Clinical trial NCT05242640: Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Official title: Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Feasibility of screening: screened to eligible ratio
timeFrame: Through study completion, an average of 1 year
measure: Feasibility of enrollment: eligible to enrollment ratio
timeFrame: Through study completion, an average of 1 year
measure: Feasibility of retention: retention at each assessment
timeFrame: 6 months
measure: Feasibility of interventions: attendance rates for each session
timeFrame: 6 months
measure: Feasibility of survey completion: survey completion rates at each assessment
timeFrame: 6 months
measure: Acceptability of interventions
timeFrame: 6 months
measure: Acceptability of study design
timeFrame: 6 months
measure: Perspectives on study interventions
timeFrame: Post-intervention (after 8 week intervention)
Secondary outcomes:
measure: Ventilatory efficiency
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention)
measure: Heart rate dynamics
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention)
measure: Positive affect
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
measure: Emotion regulation
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
measure: Interoceptive awareness
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
measure: Self-efficacy
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
measure: Self-reported physical activity
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention), 3 months post-intervention
measure: Objective physical activity
timeFrame: Baseline (week 0), post-intervention (after 8 week intervention)
measure: In-session oxygen consumption
timeFrame: Weeks 1 and 8
measure: In-session ventilatory efficiency
timeFrame: Weeks 1 and 8
measure: In-session respiration rate
timeFrame: Weeks 1 and 8
measure: In-session heart rate
timeFrame: Weeks 1 and 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: