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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05611333

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Physical Inactivity Sedentary Behavior	Behavioral: Physician-Led Remote Exercise Program Intervention	N/A

Detailed Description

This study will employ a mixed methods design including a pilot randomized controlled trial (RCT), followed by semi-structured interviews, 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.

Following completion of the 4-week intervention, 10 participants in the intervention arm will be asked to participate in brief semi-structured interviews to provide general feedback on the exercise program.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

BE-PHIT: a Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physician-Led Remote Exercise Program Intervention Participants randomized to the intervention arm will attend three 45-minute walking sessions over Zoom per week for 4 weeks. Additionally, 10 people in this group will be asked to participate in brief interviews after the program for feedback on the program. All participants will be asked to wear Fitbit activity trackers to track steps every day and to regularly use blood pressure cuffs to measure blood pressure at home. All participants will also be asked to complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.	Behavioral: Physician-Led Remote Exercise Program Intervention The physician-led remote exercise program intervention consists of three 45-minute walking classes on Zoom per week for 4 weeks.
No Intervention: Control Participants in the control group will continue with usual care. All participants will be asked to wear Fitbit activity trackers to track steps every day and to regularly use blood pressure cuffs to measure blood pressure at home. All participants will also be asked to complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.

Arm

Intervention/Treatment

Experimental: Physician-Led Remote Exercise Program Intervention

Participants randomized to the intervention arm will attend three 45-minute walking sessions over Zoom per week for 4 weeks. Additionally, 10 people in this group will be asked to participate in brief interviews after the program for feedback on the program. All participants will be asked to wear Fitbit activity trackers to track steps every day and to regularly use blood pressure cuffs to measure blood pressure at home. All participants will also be asked to complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.

Behavioral: Physician-Led Remote Exercise Program Intervention

The physician-led remote exercise program intervention consists of three 45-minute walking classes on Zoom per week for 4 weeks.

No Intervention: Control

Participants in the control group will continue with usual care. All participants will be asked to wear Fitbit activity trackers to track steps every day and to regularly use blood pressure cuffs to measure blood pressure at home. All participants will also be asked to complete a brief set of surveys at the beginning of the study, after 4 weeks, and after 12 weeks.

Outcome Measures

Primary Outcome Measures

Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week [4 weeks]
This will be assessed based on documented physical activity on Fitbit devices provided to all participants. A third-party research application program interface (API) called Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Using its proprietary algorithm, the Fitbit tracker will convert raw acceleration data into activity counts in 60-s sampling intervals that define activity intensities as 0 = sedentary, 1 = light PA, 2 = moderate PA, and 3 = vigorous PA. MVPA minutes per week will be extracted through Fitabase (Semanik et al., 2019).

Secondary Outcome Measures

Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week [12 weeks]
This will be assessed based on documented physical activity on Fitbit devices provided to all participants. Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Using its proprietary algorithm, the Fitbit tracker will convert raw acceleration data into activity counts in 60-s sampling intervals that define activity intensities as 0 = sedentary, 1 = light PA, 2 = moderate PA, and 3 = vigorous PA. MVPA minutes per week will be extracted through Fitabase (Semanik et al., 2019).
Proportion of patients achieving guideline-recommended volume of physical activity [4 weeks and 12 weeks]
Standard clinical guidelines recommend 150 minutes/week of moderate intensity or 75 minutes/week of vigorous intensity physical activity (Fihn et al., 2012). This will be measured based on objective physical activity captured on Fitbit devices provided to all participants. Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Using its proprietary algorithm, the Fitbit tracker will convert raw acceleration data into activity counts in 60-s sampling intervals that define activity intensities as 0 = sedentary, 1 = light PA, 2 = moderate PA, and 3 = vigorous PA. MVPA minutes per week will be extracted through Fitabase (Semanik et al., 2019).
Change in minutes of sedentary time/week [4 weeks and 12 weeks]
Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Using its proprietary algorithm, the Fitbit tracker will convert raw acceleration data into activity counts in 60-s sampling intervals that define activity intensities as 0 = sedentary, 1 = light PA, 2 = moderate PA, and 3 = vigorous PA (Redenius et al., 2019). Sedentary time per week will be extracted through Fitabase.

Other Outcome Measures

Self-reported physical activity [4 and 12 weeks]
This will be assessed by the validated Exercise as a Vital Sign instrument (Grant et al., 2014).
Change in weight (kg) [4 and 12 weeks]
This will be assessed based on reported weights by participants
Change in blood pressure (mmHg) [4 and 12 weeks]
This will be assessed based on reported home blood pressure measurements using study-provided automatic blood pressure cuffs.
Change in resting heart rate (bpm) [4 and 12 weeks]
This will be determined from Fitbit tracker data. Fitabase (Small Steps Labs, LLC, San Diego, CA) will be used to exporting the data from the Fitbit at 60-second sampling intervals. Resting heart rate data will be extracted through Fitabase.
Self-determination [4 and 12 weeks]
Self-determination is a psychology framework for human motivation and behavior that posits that individuals adopt and persist in activities when they are intrinsically motivated or when they have extrinsic motivation modulated by the belief that such activities are consistent with one's identity or that they will result in important outcomes (Teixeira et al., 2012). Self-determination will be assessed by administration of the validated Exercise Regulations Questionnaire (Wilson et al., 2006).
Psychological need satisfaction [4 and 12 weeks]
Fulfillment of psychological needs for autonomy, competence, and relatedness is a key driver of intrinsic motivation. Therefore, psychological need satisfaction will be assessed by the validated Psychological Need Satisfaction in Exercise Scale (Wilson et al, 2006).
Well-being [4 and 12 weeks]
Health-related well-being will be assessed by the validated WHO-5 Well-Being Scale (Topp et al., 2015).
Health-related quality of life [4 and 12 weeks]
Health-related quality of life will be assessed by the validated Short Form-36 Survey (Failde et al., 2000).
General satisfaction [4 weeks]
General satisfaction with the exercise program will be assessed among participants randomized to the intervention arm with a 5-point Likert scale general satisfaction survey where 1 = very dissatisfied and 5 = very satisfied.
Likelihood to recommend [4 weeks]
The likelihood to recommend the exercise program will be assessed in intervention participants with the validated Net Promoter Score where 1 = not at all likely to recommend and 10 = very likely to recommend.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 40-75 years
Female sex
Diagnosis 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) with
Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI.
Stress test completed within 12 months after diagnosis of MI
Completed visit with Mass General Brigham (MGB) cardiologist within 12 months prior to enrollment
Self-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 independently
Possession of and ability to use a computer and/or smart device with video conferencing capability
Willing 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/injuries
Severe mental or cognitive disabilities
Inability to speak English