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Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial ((PACE-life)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173572
Recruitment Status : Active, not recruiting
First Posted : November 22, 2019
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder.

Participants: 56 individuals with schizophrenia spectrum disorders.

Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day.

Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Brief Psychotic Disorder Schizophreniform Disorders Unspecified Schizophrenia Spectrum and Other Psychotic Disorder Behavioral: PACE-Life Behavioral: Exercise Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking Group
Participants will be walking two times a week in supervised groups with the psychiatric clinic and will also participate in independent walks done at a location of their own choosing outside group participation.
Behavioral: PACE-Life
PACE-Life Groups will occur twice per week for 30 minutes for the entire intervention without changes in frequency and duration. The intensity, however, of both group walks and home-based walks will increase throughout this intervention in a step-wise fashion to create an exercise dose response to maximize impact on CRF.
Other Name: Exercise Intervention

Active Comparator: Fitbit Alone
Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues.
Behavioral: Exercise Intervention
Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking.
Other Name: Fitbit




Primary Outcome Measures :
  1. Difference in Participant's Total Distance During 6-minute Walk [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).


Secondary Outcome Measures :
  1. Mean Difference in Minutes Spent Walking [ Time Frame: Baseline and the last study visit (up to 20 weeks) ]
    Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.

  2. Mean Difference in Daily Steps [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.

  3. Mean Difference Overall UCLA Loneliness Scale Score [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).

  4. Mean Difference Overall PANSS Score [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).

  5. Mean Difference in Body Weight Change [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).

  6. Mean difference in blood pressure change [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).

  7. Mean Difference in Resting Heart Rate Change [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).


Other Outcome Measures:
  1. Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).

  2. Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).

  3. Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).

  4. Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).

  5. Mean Difference in Composite Score on the Autonomy Support Scale [ Time Frame: Baseline and the last study visit (Up to 20 weeks) ]
    Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.

  6. End of Study Survey [ Time Frame: Post treatment only (16 weeks) ]
    Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-V diagnosis of a SSD (Schizophrenia, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, and Unspecified Schizophrenia Spectrum and Other Psychotic Disorder)
  • Between the ages of 18-65, both genders, and any ancestry
  • IQ>70. IQ will be assessed using the WASI
  • No hospitalizations for psychiatric reasons in the last 3 months
  • Clinically stable (no psychiatric medication changes within the past month)
  • Are not already engaging in consistent moderate-intensity exercise (cutoff = 60 min/week for the past 6 months)
  • Present with no contra-indication to engage in regular moderate intensity exercise based on the American College of Sports Medicine guidelines
  • Willing and able to provide informed consent or has legal guardian present to provide informed consent.

Exclusion Criteria:

  • Pregnant women will be excluded because pregnancy alters autonomic and immune responsiveness, increase weight gain, and can influence heart rate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173572


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
North Carolina Psychiatric Research Center
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: David L Penn, PhD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04173572    
Other Study ID Numbers: 19-2286
1R34MH111852-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time Frame: 9 to 36 months following publication
Access Criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Walking
Exercise
Physical Health
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes