Clinical trial NCT05611333: A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
Official title: BE-PHIT: a Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Physical Inactivity
Sedentary Behavior
Keywords: Coronary Artery Disease
Exercise
Behavior change
Physical activity
Sedentary behavior
Fitness
Behavioral science
Women's health
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 59
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Ischemic heart disease is the leading cause of death in the United States and worldwide (Nowbar et al., 2019). Exercise has been shown to be effective in preventing repeat heart attacks, hospitalizations and death among heart attack survivors (Lawler et al., 2011). But, few heart attack survivors -- particularly women -- get the recommended amount of physical activity (Minges et al., 2017; Gorczyca et al., 2017). The goal of this pilot study is to test the potential of an innovative new doctor-led exercise program to improve physical activity and quality of life for women who have had heart attacks in the past. Women who take part in the study will be randomly assigned to participation in the exercise program (which will consist of three 45-minute exercise sessions on Zoom per week) or usual care (attending medical appointments and following doctors' recommendations). All participants will be asked to wear Fitbit activity trackers to track steps every day, to use blood pressure cuffs to measure blood pressure at home, and complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.

Detailed description: This study will employ a pilot randomized controlled trial (RCT) design to compare an intervention group and a control group receiving usual care.

The pilot RCT will include 60 sedentary adult women with a history of stable coronary artery disease (CAD) who will be randomized to the intervention arm (4-week physician-led remote exercise program) or usual care. The primary outcome will be change in minutes/week of moderate-to-vigorous physical activity (MVPA) at 4 weeks, which will be measured with Fitbit trackers provided to all participants. Secondary outcomes will include change in MVPA at 12 weeks, the proportion of patients achieving guidelines-recommended volumes of physical activity (PA) at 4 and 12 weeks, change in minutes of sedentary time per week at 4 and 12 weeks, change in cardiometabolic health measures (e.g. self-reported weight, blood pressure, and resting heart rate), and change in survey-based measures of self determination, intrinsic motivation, well-being, and quality of life. Additional feasibility outcomes will include satisfaction, and likelihood to recommend.

Eligibility criteria: Inclusion Criteria:

1. Age 40-80 years 2. Female sex 3. Diagnosis of coronary artery disease that meets criteria for one of the following:

a. Stable obstructive CAD i. A history of myocardial infarction (MI) at least 12 months prior to enrollment, history of coronary artery bypass graft surgery (CABG), and/or history of percutaneous coronary intervention (PCI) with

1. Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI AND
2. Stress test (completed within 12 months after diagnosis of MI OR within 5 years prior to enrollment) OR
3. Absence of anginal symptoms following revascularization ii. Previous imaging (e.g. coronary computed tomographic angiography \[CCTA\] or coronary angiography) demonstrating any stenosis 50% or greater in the left main coronary artery, 70% or greater in any other coronary artery, or both.

   b. Non-obstructive CAD i. Previous imaging (e.g. CCTA or coronary angiography) with/without additional stress testing demonstrating coronary artery stenosis 1 to 49% in the left main coronary artery or 1-70% in any other epicardial coronary artery with or without stress testing negative for ischemia.

   ii. Previous imaging (e.g. calcium scoring or conventional computed tomography) demonstrating calcified coronary artery plaque with or without stress testing negative for ischemia.
4. Completed visit with Mass General Brigham (MGB) cardiologist within 12 months prior to enrollment
5. Self-reported physical inactivity (any amount of PA less than guideline-recommended amount of 150 minutes/week of at least moderate intensity aerobic exercise)10 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument11
6. Ability to ambulate independently
7. Possession of and ability to use a computer and/or smart device with video conferencing capability
8. Possession of and willing to use a home scale daily.
9. Willing to use a Fitbit activity tracker daily.

Exclusion Criteria:

1. A history of conditions that limit or contraindicate exercise (e.g., myocardial infarction within 48 hours, unstable angina, heart failure with reduced ejection fraction, severe aortic stenosis, uncontrolled cardiac arrhythmias, myocarditis, acute pulmonary embolism, severe pulmonary hypertension, aortic dissection, hypertrophic obstructive cardiomyopathy, hypertension greater than 200/110 mmHg, known obstruction of the left coronary artery)
2. Musculoskeletal or plantar wounds/injuries
3. Severe mental or cognitive disabilities
4. Inability to speak English

Primary outcomes:
measure: Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
timeFrame: 12 weeks
measure: Proportion of patients achieving guideline-recommended volume of physical activity
timeFrame: 4 weeks and 12 weeks
measure: Change in minutes of sedentary time/week
timeFrame: 4 weeks and 12 weeks
Other outcomes:
measure: Self-reported physical activity
timeFrame: 4 and 12 weeks
measure: Change in weight (kg)
timeFrame: 4 and 12 weeks
measure: Change in blood pressure (mmHg)
timeFrame: 4 and 12 weeks
measure: Change in resting heart rate (bpm)
timeFrame: 4 and 12 weeks
measure: Self-determination
timeFrame: 4 and 12 weeks
measure: Psychological need satisfaction
timeFrame: 4 and 12 weeks
measure: Well-being
timeFrame: 4 and 12 weeks
measure: Health-related quality of life
timeFrame: 4 and 12 weeks
measure: General satisfaction
timeFrame: 4 weeks
measure: Likelihood to recommend
timeFrame: 4 weeks
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Simin G Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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