An interventional study of Physician-Led Remote Exercise Program Intervention in Coronary Artery Disease, Physical Inactivity and Sedentary Behavior, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention
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.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 59 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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.
Exclusion Criteria:
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
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.
The physician-led remote exercise program intervention consists of three 45-minute walking classes on Zoom per week for 4 weeks.
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
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).
Time frame: 4 weeks
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
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).
Time frame: 12 weeks
Proportion of patients achieving guideline-recommended volume of physical activity
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).
Time frame: 4 weeks and 12 weeks
Change in minutes of sedentary time/week
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.
Time frame: 4 weeks and 12 weeks
Self-reported physical activity
This will be assessed by the validated Exercise as a Vital Sign instrument (Grant et al., 2014).
Time frame: 4 and 12 weeks
Change in weight (kg)
This will be assessed based on reported weights by participants
Time frame: 4 and 12 weeks
Change in blood pressure (mmHg)
This will be assessed based on reported home blood pressure measurements using study-provided automatic blood pressure cuffs.
Time frame: 4 and 12 weeks
Change in resting heart rate (bpm)
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.
Time frame: 4 and 12 weeks
Self-determination
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).
Time frame: 4 and 12 weeks
Psychological need satisfaction
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).
Time frame: 4 and 12 weeks
Well-being
Health-related well-being will be assessed by the validated WHO-5 Well-Being Scale (Topp et al., 2015).
Time frame: 4 and 12 weeks
Health-related quality of life
Health-related quality of life will be assessed by the validated Short Form-36 Survey (Failde et al., 2000).
Time frame: 4 and 12 weeks
General satisfaction
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.
Time frame: 4 weeks
Likelihood to recommend
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.
Time frame: 4 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Ran from Nov 2022 to primary completion in May 2023, 6 months.
Of 856 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 6 months is below that.
Counting every sponsor, half of 1,033 studies reached it within 29 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital →