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

October 19, 2023 updated by: Simin G. Lee, Brigham and Women's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
Time Frame: 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).
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
Time Frame: 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).
12 weeks
Proportion of patients achieving guideline-recommended volume of physical activity
Time Frame: 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).
4 weeks and 12 weeks
Change in minutes of sedentary time/week
Time Frame: 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.
4 weeks and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical activity
Time Frame: 4 and 12 weeks
This will be assessed by the validated Exercise as a Vital Sign instrument (Grant et al., 2014).
4 and 12 weeks
Change in weight (kg)
Time Frame: 4 and 12 weeks
This will be assessed based on reported weights by participants
4 and 12 weeks
Change in blood pressure (mmHg)
Time Frame: 4 and 12 weeks
This will be assessed based on reported home blood pressure measurements using study-provided automatic blood pressure cuffs.
4 and 12 weeks
Change in resting heart rate (bpm)
Time Frame: 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.
4 and 12 weeks
Self-determination
Time Frame: 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).
4 and 12 weeks
Psychological need satisfaction
Time Frame: 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).
4 and 12 weeks
Well-being
Time Frame: 4 and 12 weeks
Health-related well-being will be assessed by the validated WHO-5 Well-Being Scale (Topp et al., 2015).
4 and 12 weeks
Health-related quality of life
Time Frame: 4 and 12 weeks
Health-related quality of life will be assessed by the validated Short Form-36 Survey (Failde et al., 2000).
4 and 12 weeks
General satisfaction
Time Frame: 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.
4 weeks
Likelihood to recommend
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Simin G Lee, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

May 28, 2023

Study Completion (Actual)

July 23, 2023

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P002541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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