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Recruiting NCT05611333

A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease

Conditions: Coronary Artery Disease, Physical Inactivity, Sedentary Behavior

Sex: Female
Ages: 40 Years – 75 Years
Phase: NA
Enrollment: 60
Sponsor: Brigham and Women's Hospital

Location: United States

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. Additionally, 10 people in the exercise group group will be asked to participate in brief interviews after the program for feedback on the program.

Eligibility Criteria

Inclusion Criteria:Age 40-75 yearsFemale sexDiagnosis of coronary artery disease with 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) withCoronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI.Stress test completed within 12 months after diagnosis of MICompleted visit with Mass General Brigham (MGB) cardiologist within 12 months prior to enrollmentSelf-reported physical inactivity (any amount of PA less than guideline-recommended amount of 150 minutes/week of at least moderate intensity aerobic exercise)8 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument (Grant et al., 2014).Ability to ambulate independentlyPossession of and ability to use a computer and/or smart device with video conferencing capabilityWilling to use a Fitbit activity tracker daily.Exclusion Criteria: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)Musculoskeletal or plantar wounds/injuriesSevere mental or cognitive disabilitiesInability to speak English

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611333). StuddyBuddy aggregates publicly available trial information.