Exploring mind-body exercises to improve physical activity in people with metabolic syndrome

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

This study is testing different mind-body exercise programs to see if they can help people with metabolic syndrome be more active and how well participants like them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05242640 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility and acceptability of a pilot factorial design that investigates different components of mind-body exercise interventions for individuals with metabolic syndrome. Participants will be assigned to one of four groups: a walking program, a mindful attention program, a combination of both, or no program at all. The study will assess factors such as enrollment, adherence, retention, and participant feedback on the interventions. By understanding these components, the research seeks to inform future larger-scale studies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with metabolic syndrome who are insufficiently active and have medical clearance for moderate-intensity exercise.

Not a fit: Patients with current diagnoses of coronary artery disease or other chronic heart diseases that contraindicate exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance physical activity engagement among patients with metabolic syndrome, potentially improving their overall health outcomes.

How similar studies have performed: Other studies have shown promise in using mind-body interventions for improving health outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Boston, Massachusetts

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

Study contacts

• Study coordinator: Kristen M Kraemer, PhD

Conditions Metabolic Syndrome