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

Beth Israel Lahey Health

Status: Enrolling

Conditions: Metabolic Syndrome

Treatments: Other: Mindful attention; Other: Exercise with mindful attention; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05242640

2022P000037

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Mindful attention

Experimental group

Description:

16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones

Treatment:

Other: Mindful attention

Exercise

Experimental group

Description:

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking

Treatment:

Other: Exercise

Exercise with mindful attention

Experimental group

Description:

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones

Treatment:

Other: Exercise with mindful attention

No intervention

No Intervention group

Description:

No intervention sessions