Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT05242640
• Recruitment Status: Recruiting
• First Posted: February 16, 2022
• Last Update Posted: February 8, 2023
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Kristen Kraemer, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

The aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. The study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. A "pilot" study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Other: Mindful attention; Other: Exercise; Other: Exercise with mindful attention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
• Actual Study Start Date: January 31, 2023
• Estimated Primary Completion Date: April 2025
• Estimated Study Completion Date: March 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mindful attention; 16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones	Other: Mindful attention; Participants will listen to mindful attention audio recordings via headphones
Experimental: Exercise; 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking	Other: Exercise; Participants will complete a moderate-intensity walking program
Experimental: Exercise with mindful attention; 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones	Other: Exercise with mindful attention; Participants will complete a moderate-intensity walking program while listening to mindful attention audio recordings via headphones
No Intervention: No intervention; No intervention sessions

Outcome Measures

Primary Outcome Measures :

1. Feasibility of screening: screened to eligible ratio [ Time Frame: Through study completion, an average of 1 year ]
   percent of screened individuals that were determined eligible for the study
2. Feasibility of enrollment: eligible to enrollment ratio [ Time Frame: Through study completion, an average of 1 year ]
   percent of eligible individuals that enroll in the study; determined to be feasible if greater than or equal to 70% of eligible patients enroll
3. Feasibility of retention: retention at each assessment [ Time Frame: 6 months ]
   percent of enrolled participants retained at post-intervention and 3-month follow-up; determined to be feasible if greater than or equal to 70% retention at each assessment
4. Feasibility of interventions: attendance rates for each session [ Time Frame: 6 months ]
   percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions
5. Feasibility of survey completion: survey completion rates at each assessment [ Time Frame: 6 months ]
   percent of participants that complete surveys at post-intervention and 3-month follow-up
6. Acceptability of interventions [ Time Frame: 6 months ]
   Acceptability of the interventions will be assessed via overall satisfaction (1 = not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions
7. Acceptability of study design [ Time Frame: 6 months ]
   Acceptability of the study design will be assessed via acceptability of study procedures (1= not at all to 10 = very much); determined to be acceptable if mean rating is greater than or equal to 7.5 across 80% of sessions
8. Perspectives on study interventions [ Time Frame: Post-intervention (after 8 week intervention) ]
   Perspectives on study interventions will be assessed via exit interview

Secondary Outcome Measures :

1. Ventilatory efficiency [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention) ]
   Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring.
2. Heart rate dynamics [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention) ]
   Assessed via 24-hour heart rate monitoring
3. Positive affect [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention ]
   Positive and Negative Affect Schedule, a validated self-report measure, used to assess levels of positive affect. The positive affect subscale is made up of 10 items rated on a 5-point Likert scale. Scores range from 10 to 50 with higher scores indicating greater levels of positive affect
4. Emotion regulation [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention ]
   Difficulties in Emotion Regulation Scale, a 36-item validated self-report measure, used to assess difficulties with emotion regulation; items are rated on a 5-point Likert scale, total scores range from 36 to 180, with higher scores reflecting greater emotion regulation difficulties. 6 subscale scores with higher scores reflecting greater emotion regulation difficulties.
5. Interoceptive awareness [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention ]
   Multidimensional Assessment of Interoceptive Awareness Scale, a 32-item validated self-report measures, used to assess levels of interoceptive awareness; items are rated on a 6-point Likert scale, total scores range from 0 to 160, with higher scores reflecting greater interoceptive awareness. 8 subscales with higher scores reflecting greater interocpetive awareness
6. Self-efficacy [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention ]
   Multidimensional Self-Efficacy Scale, a 9-item validated self-report measure, used to assess levels of self-efficacy; scores range from 0-90 with higher scores reflecting greater self-efficacy
7. Self-reported physical activity [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention ]
   International Physical Activity Questionnaire, a validated self-report measure, used to assess levels of physical activity; walking MET mins/week, moderate MET mins/week and vigorous MET mins/week are calculated
8. Objective physical activity [ Time Frame: Baseline (week 0), post-intervention (after 8 week intervention) ]
   7 day activity monitoring (via ActiGraph monitor) to assess minutes per week in moderate-intensity exercise
9. In-session oxygen consumption [ Time Frame: Weeks 1 and 8 ]
   Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
10. In-session ventilatory efficiency [ Time Frame: Weeks 1 and 8 ]
    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
11. In-session respiration rate [ Time Frame: Weeks 1 and 8 ]
    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
12. In-session heart rate [ Time Frame: Weeks 1 and 8 ]
    Submaximal cardiopulmonary exercise testing (via standard metabolic cart)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 6 months at the time of medical record review: (a) BMI > 30; (b) fasting glucose ≥ 100 [5.6 mmol/L] or A1C ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/L or medications; (e) or HDL < 40mg/ dL for men and 50mg/dL for women or medications;
• insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on Godin-Shepard Leisure-Time Physical Activity Questionnaire;
• age 18-70 years;
• given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (PCP);
• access to a device with internet and videoconferencing capabilities

Exclusion Criteria:

• current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment
• >2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months
• self-reported inability to speak and read in English
• current beta blocker or calcium channel blocker medication
• uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months
• self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)

Contacts and Locations

Contacts

Contact: Kristen M Kraemer, PhD; 617-754-1443; kkraemer@bidmc.harvard.edu

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Kristen Kraemer, PhD 617-754-1443 kkraemer@bidmc.harvard.edu

Principal Investigator: Kristen M Kraemer, PhD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Kristen Kraemer, Instructor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT05242640
• Other Study ID Numbers: 2022P000037
• First Posted: February 16, 2022
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases