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University of Wisconsin Meditation & Exercise Cold Study (MEPARI-2)

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ClinicalTrials.gov Identifier: NCT01654289
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Acute Respiratory Infection
Interventions Other: Mindfulness Meditation
Other: Exercise
Enrollment 413

Recruitment Details Participants recruited from the greater Madison WI (USA) community between July 2012 and September 2016.
Pre-assignment Details Prospective subjects were met in person for informed consent and enrollment in a 2-week run-in trial. Run-in tasks included baseline questionnaires, at least one phone contact, self-report questionnaires at home, and a follow-up in-person appointment. Successful completion of run-in activities allowed participants to enroll in main study.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Period Title: Overall Study
Started 138 137 138
Completed 111 109 133
Not Completed 27 28 5
Reason Not Completed
Withdrawal by Subject             10             8             5
Withdrew from intervention only             17             20             0
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control Total
Hide Arm/Group Description

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants. Total of all reporting groups
Overall Number of Baseline Participants 138 137 138 413
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 137 participants 138 participants 413 participants
49.1  (11.4) 49.2  (11.2) 50.7  (12.1) 49.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 137 participants 138 participants 413 participants
Female
105
  76.1%
107
  78.1%
101
  73.2%
313
  75.8%
Male
33
  23.9%
30
  21.9%
37
  26.8%
100
  24.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 137 participants 138 participants 413 participants
Hispanic or Latino
11
   8.0%
5
   3.6%
8
   5.8%
24
   5.8%
Not Hispanic or Latino
127
  92.0%
132
  96.4%
130
  94.2%
389
  94.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 137 participants 138 participants 413 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   3.6%
8
   5.8%
3
   2.2%
16
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   3.6%
14
  10.2%
6
   4.3%
25
   6.1%
White
121
  87.7%
105
  76.6%
123
  89.1%
349
  84.5%
More than one race
7
   5.1%
10
   7.3%
6
   4.3%
23
   5.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 138 participants 137 participants 138 participants 413 participants
138 137 138 413
1.Primary Outcome
Title Severity-weighted Total Days of ARI Illness
Hide Description The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Measure Type: Number
Unit of Measure: severity*days
1045 1010 1210
2.Secondary Outcome
Title Absenteeism
Hide Description Employment, including type of work, hours per week worked, and compensation, assessed as hourly wage, will be assessed at enrollment. Each week throughout the study participants will complete questions to assess number of hours of work missed. Study personnel blinded to allocation group status will assess and classify reasons for missed work as either ARI-related or not ARI-related. Presented as a total cumulative number of days missed of work due to an ARI-related event.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Measure Type: Number
Unit of Measure: Total # of ARI-related Missed Work days
73 81 105
3.Secondary Outcome
Title Health Care Utilization
Hide Description Cumulative total number of health care visits, ARI-related health care visits, and ARI-related prescriptions, including antibiotics and anti-influenza anti-virals will be documented. Each weekly communication will include the question, "Have you seen a doctor or visited a clinic, hospital or urgent care center?" Persons answering "Yes" will be asked the reason for the visit. Those answers will then be classified by blinded study personnel as either "Related," or "Unrelated" to ARI illness, including upper respiratory infection, influenza, pharyngitis, acute sinusitis, bronchitis, and pneumonia.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Measure Type: Number
Unit of Measure: Total # ARI-related Medical visits
22 21 24
4.Secondary Outcome
Title SF-12
Hide Description Also known as the Medical Outcomes Study Short Form, this 12-item questionnaire is commonly used to measure overall health, including physical (SF12-P) and mental health (SF12-M) subscales. It has been extensively assessed for reliability, responsiveness and criterion validity. In this study, it will be used to assess potential changes in general physical and mental health due to interventions, and as a covariate to control for baseline between-person differences in multivariate efficacy analyses. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame Baseline and 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: score on a scale
SF12-P Baseline Number Analyzed 138 participants 137 participants 138 participants
51.2
(35.6 to 67.1)
51.4
(34.9 to 67.8)
51.4
(35.1 to 67.6)
SF-12-P Exit Number Analyzed 129 participants 129 participants 129 participants
50.5
(31.4 to 71.7)
51.9
(32.2 to 70.9)
51.5
(33.9 to 69.2)
SF12-M Baseline Number Analyzed 138 participants 137 participants 138 participants
48.0
(28.0 to 67.1)
47.9
(27.1 to 68.0)
47.6
(28.2 to 66.9)
SF-12-M Exit Number Analyzed 128 participants 129 participants 132 participants
49.7
(25.2 to 66.5)
47.8
(26.2 to 65.6)
45.9
(25.1 to 66.6)
5.Secondary Outcome
Title Perceived Stress Scale (PSS-10)
Hide Description

The PSS-10 has been validated in multiple studies. PSS scores predict rates of viral infection among volunteers inoculated with rhinovirus, and correlate with physiologic and self-report indicators of ARI illness, including nasal IL-6 level. Because stress reduction is one of the hypothesized mechanisms of action, this study population will include working-age participants, who are presumed to be more stressed. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  • Scores ranging from 0-13 would be considered low stress.
  • Scores ranging from 14-26 would be considered moderate stress.
  • Scores ranging from 27-40 would be considered high perceived stress.
Time Frame Baseline and 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: score on a scale
PSS-10 Baseline Number Analyzed 138 participants 137 participants 138 participants
13.1
(-0.3 to 25.0)
13.3
(-0.5 to 25.3)
12.4
(0.8 to 24.0)
PSS-10 Exit Number Analyzed 128 participants 129 participants 133 participants
11.6
(0.8 to 26)
13.3
(-0.5 to 27.4)
13.4
(0.6 to 26.2)
6.Secondary Outcome
Title Mindfulness-based Self Efficacy Scale (MSES)
Hide Description

The MSES is one of the more recent questionnaires, developed by Cayoun and Freestun to assess effects of MBSR training on perceived self-efficacy. The MSES assesses 7 domains related to mindfulness self-efficacy, including behavior, cognition, interoception, affect, interpersonal, avoidance and mindfulness. The MSES will provide a nice counterpart to the ESES to help distinguish effects of interventions on ARI outcomes. The lower the score, the lower self-efficacy is in using mindfulness skills.

The current lack of psychometric data for the MSES renders the following ranges very tentative. They are currently only a rough clinical guide and scores must be interpreted with caution.

0-34 Poor sense of self-efficacy 35-69 Weak sense of self-efficacy 70-104 Moderate sense of self-efficacy 105-140 Good sense of self-efficacy

Time Frame 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Standard Deviation)
Unit of Measure: score on a scale
97.6  (15.7) 97.3  (14.7) 96.8  (14.6)
7.Secondary Outcome
Title Exercise Self-Efficacy Scale (ESES)
Hide Description Self-efficacy has been defined as "the belief in one's capabilities to organize and execute the courses of action required to manage prospective situations." The ESES scale was developed based on work by Bandura and colleagues,and has been validated by Shin, Kroll,and Everett. For this study, the ESES will be used to verify results of the exercise intervention, and to help explain potential mediational effects of exercise. The total score is derived by summing the scores for the individual items; possible scores range from 0 to 180. Total score (out of 180) is sum of item scores. Higher score represents greater perceived self efficacy.
Time Frame Baseline and 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: score on a scale
ESES - Baseline Number Analyzed 138 participants 136 participants 137 participants
112.5
(41.0 to 191.0)
112.4
(40.3 to 191.6)
116.0
(39.9 to 192.1)
ESES - Exit Number Analyzed 128 participants 129 participants 138 participants
94.3
(8.9 to 160.2)
104.4
(13.4 to 155.8)
84.6
(13.3 to 155.9)
8.Secondary Outcome
Title Pittsburgh Sleep Quality Index (PSQI)
Hide Description Sleep quality has been linked to several important quality of life and health outcomes. The PSQI is widely used and has been assessed for reliability and validity.In this study, improved sleep is a potential mediator of intervention effects, and a potentially important outcome on its own. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Time Frame Baseline and 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: score on a scale
PSQI - BASELINE Number Analyzed 136 participants 133 participants 136 participants
5.8
(-0.7 to 12.0)
6.2
(-1.4 to 12.7)
5.7
(-0.8 to 12.1)
PSQI - EXIT Number Analyzed 128 participants 127 participants 132 participants
5.1
(-0.1 to 11.8)
5.3
(-0.4 to 12.0)
5.8
(-1.3 to 13.0)
9.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description Body habitus is associated with many disease processes, and may be related to immune function and susceptibility to respiratory infection. Height will be assessed at baseline only. Weight will be measured at baseline, 1 and 4 months post-intervention, and at exit. Baseline BMI will be calculated and used as a covariate in statistical models. BMI will also be considered a secondary outcome of potential importance.
Time Frame Baseline and 8 months (exit from study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: kg/m2
BMI - BASELINE Number Analyzed 138 participants 137 participants 138 participants
29.8
(13.7 to 44.4)
29.3
(15.4 to 42.7)
29.0
(16.0 to 42.0)
BMI - EXIT Number Analyzed 128 participants 128 participants 132 participants
28.2
(24.2 to 33.4)
27.4
(24.3 to 32.0)
27.9
(24.1 to 33.0)
10.Secondary Outcome
Title Blood Pressure
Hide Description Standard brachial blood pressure will be assessed by trained nurses using calibrated sphygmomanometers.
Time Frame Baseline and 8 months (exit from study)
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Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Mean (Full Range)
Unit of Measure: mm Hg
Systolic - Baseline Number Analyzed 138 participants 137 participants 138 participants
120.4
(92.0 to 156.4)
121.8
(94.2 to 154.2)
124.2
(91.6 to 156.8)
Diastolic-Baseline Number Analyzed 138 participants 137 participants 138 participants
74.3
(59.4 to 92.3)
75.0
(58.3 to 93.4)
75.8
(57.7 to 94.0)
Systolic - Exit Number Analyzed 127 participants 127 participants 131 participants
121.0
(109.0 to 133.0)
122.0
(108.0 to 130.0)
124.0
(113.0 to 132.0)
Diastolic - Exit Number Analyzed 127 participants 127 participants 131 participants
77.0
(69.0 to 82.0)
76.0
(69.0 to 82.0)
78.0
(71.0 to 83.0)
11.Secondary Outcome
Title Pro-Inflammatory Cytokines
Hide Description Laboratory-assessed objective measures will primarily serve to corroborate self-reports of disease severity. High sensitivity C-reactive protein (HS-CRP) is a well-established indicator of disease severity during respiratory infection, and can be measured in serum and in nasal wash.Concentrations of interleukin-6 (IL-6)and interleukin-8 (IL-8)in nasal wash have been shown to correlate with illness severity. More recently, interferon-gamma-induced protein 10 (IP-10) has been shown to be measurably increased in both serum and nasal wash during times of acute viral ARI. Biomarker levels were measured at the two standardized follow-up visits in December and March when participants were not ill.
Time Frame Baseline, 4 months post-intervention (December) and 8 months post-intervention (March).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obtained participant data reported.
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description:

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
Overall Number of Participants Analyzed 138 137 138
Median (Full Range)
Unit of Measure: pg/mL
hsCRP - Baseline Number Analyzed 138 participants 137 participants 138 participants
1.6
(0.7 to 4.5)
1.4
(0.6 to 3.9)
1.5
(0.7 to 4.8)
hsCRP - December Number Analyzed 132 participants 127 participants 134 participants
1.7
(0.8 to 4.8)
1.7
(0.7 to 3.3)
1.6
(0.7 to 4.4)
hsCRP - March Number Analyzed 127 participants 126 participants 131 participants
1.3
(0.7 to 3.3)
1.3
(0.6 to 3.2)
1.4
(0.6 to 3.9)
IL-6 nasal - Baseline Number Analyzed 133 participants 129 participants 132 participants
1.3
(0.8 to 2.2)
1.0
(0.6 to 2.1)
1.1
(0.5 to 2.3)
IL-6 nasal - December Number Analyzed 138 participants 137 participants 138 participants
1.7
(0.8 to 3.9)
1.8
(0.8 to 2.9)
1.3
(0.6 to 2.8)
IL-6 nasal - March Number Analyzed 128 participants 129 participants 130 participants
1.6
(0.9 to 2.6)
1.6
(0.8 to 2.8)
1.6
(0.8 to 3.6)
IL-6 serum - Baseline Number Analyzed 138 participants 137 participants 138 participants
1.6
(1.0 to 2.8)
1.8
(1.1 to 2.9)
1.7
(1.0 to 2.9)
IL-6 serum - December Number Analyzed 132 participants 128 participants 134 participants
1.6
(0.9 to 3.2)
1.7
(1.0 to 3.0)
1.5
(1.0 to 2.6)
IL-6 serum - March Number Analyzed 127 participants 127 participants 132 participants
1.7
(0.9 to 2.6)
1.6
(0.9 to 2.5)
1.8
(1.1 to 3.0)
IP-10 - Baseline Number Analyzed 138 participants 137 participants 138 participants
141
(117 to 183)
156
(126 to 198)
152
(127 to 198)
IP-10 - December Number Analyzed 132 participants 128 participants 134 participants
140
(116 to 183)
139
(116 to 172)
148
(121 to 205)
IP-10 - March Number Analyzed 127 participants 126 participants 132 participants
149
(114 to 192)
145
(111 to 190)
147
(123 to 192)
IL-8 - Baseline Number Analyzed 138 participants 137 participants 138 participants
167
(86 to 313)
157
(79 to 271)
194
(87 to 352)
IL-8 - December Number Analyzed 133 participants 129 participants 132 participants
238
(144 to 356)
214
(127 to 354)
255
(140 to 446)
IL-8 - March Number Analyzed 128 participants 129 participants 130 participants
258
(157 to 424)
227
(158 to 414)
248
(155 to 390)
Time Frame Each cohort was followed for no more than 10 months (August through June).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mindfulness Meditation Exercise Wait-list Control
Hide Arm/Group Description

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as “experimental” participants.
All-Cause Mortality
Mindfulness Meditation Exercise Wait-list Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)      0/137 (0.00%)      0/138 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mindfulness Meditation Exercise Wait-list Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/138 (0.00%)      0/137 (0.00%)      0/138 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mindfulness Meditation Exercise Wait-list Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/138 (7.25%)      20/137 (14.60%)      16/138 (11.59%)    
Cardiac disorders       
Cardiac Disorders *  1/138 (0.72%)  1 8/137 (5.84%)  8 1/138 (0.72%)  1
General disorders       
General *  5/138 (3.62%)  5 7/137 (5.11%)  7 8/138 (5.80%)  8
Musculoskeletal and connective tissue disorders       
Musculoskeletal *  10/138 (7.25%)  10 13/137 (9.49%)  13 16/138 (11.59%)  16
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Bruce Barrett MD PhD
Organization: University of Wisconsin
Phone: 608-263-2220
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01654289     History of Changes
Other Study ID Numbers: 2012-0207
R01AT006970 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2012
First Posted: July 31, 2012
Results First Submitted: May 29, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018