Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
- Conditions
- Metabolic Syndrome
- Interventions
- Other: ExerciseOther: Mindful attentionOther: Exercise with mindful attention
- Registration Number
- NCT05242640
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) BMI ≥ 25; (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
- current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure) in which exercise would be contraindicated or that would preclude HRV analyses (e.g., some arrhythmias); (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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Exercise Exercise 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking Mindful attention Mindful attention 16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones Exercise with mindful attention Exercise with mindful attention 16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones
- Primary Outcome Measures
Name Time Method Perspectives on study interventions Post-intervention (after 8 week intervention) Perspectives on study interventions will be assessed via exit interview
Feasibility of screening: screened to eligible ratio Through study completion, an average of 1 year percent of screened individuals that were determined eligible for the study
Feasibility of retention: retention at each assessment 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
Feasibility of interventions: attendance rates for each session 6 months percent session attendance; determined to be feasible if participants attend greater than or equal to 75% of sessions
Feasibility of survey completion: survey completion rates at each assessment 6 months percent of participants that complete surveys at post-intervention and 3-month follow-up
Acceptability of interventions 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
Feasibility of enrollment: eligible to enrollment ratio 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
Acceptability of study design 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
- Secondary Outcome Measures
Name Time Method Heart rate dynamics Baseline (week 0), post-intervention (after 8 week intervention) Assessed via 24-hour heart rate monitoring
Emotion regulation 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.
Ventilatory efficiency Baseline (week 0), post-intervention (after 8 week intervention) Assessed via a maximal cardiopulmonary exercise test, using expired gas analysis under continuous electrocardiographic monitoring.
Positive affect 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
Interoceptive awareness 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
In-session oxygen consumption Weeks 1 and 8 Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
In-session respiration rate Weeks 1 and 8 Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Self-reported physical activity 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
In-session heart rate Weeks 1 and 8 Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Self-efficacy 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
Objective physical activity 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
In-session ventilatory efficiency Weeks 1 and 8 Submaximal cardiopulmonary exercise testing (via standard metabolic cart)
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States