A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
Condition: Coronary Artery Disease; Physical Inactivity; Sedentary Behavior
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

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.
    

Intervention name(s): Physician-Led Remote Exercise Program Intervention
Intervention type(s): Behavioral
Intervention description(s): The physician-led remote exercise program intervention consists of three 45-minute walking classes on Zoom per week for 4 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Coronary Artery Disease; Exercise; Behavior change; Physical activity; Sedentary behavior; Fitness; Behavioral science; Women's health