Status:
RECRUITING
Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05242640
Start Date
January 31 2023
End Date
March 31 2026
Last Update
May 23 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215