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

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT05242640

Run by

Beth Israel Deaconess Medical Center

People needed

34

Starts

2023-01-31

Expected to finish

2026-03-09

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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