Back to resultsA Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease (BE-PHIT)
Primary Purpose
Coronary Artery Disease, Physical Inactivity, Sedentary Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician-Led Remote Exercise Program Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Exercise, Behavior change, Physical activity, Sedentary behavior, Fitness, Behavioral science, Women's health
Eligibility Criteria
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 Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI AND Stress test (completed within 12 months after diagnosis of MI OR within 5 years prior to enrollment) OR 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. 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)10 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument11 Ability to ambulate independently Possession of and ability to use a computer and/or smart device with video conferencing capability Possession of and willing to use a home scale daily. 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physician-Led Remote Exercise Program Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
Full Information
NCT ID
NCT05611333
First Posted
November 3, 2022
Last Updated
October 19, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05611333
Brief Title
A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
Acronym
BE-PHIT
Official Title
BE-PHIT: a Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
May 28, 2023 (Actual)
Study Completion Date
July 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Physical Inactivity, Sedentary Behavior
Keywords
Coronary Artery Disease, Exercise, Behavior change, Physical activity, Sedentary behavior, Fitness, Behavioral science, Women's health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physician-Led Remote Exercise Program Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physician-Led Remote Exercise Program Intervention
Intervention Description
The physician-led remote exercise program intervention consists of three 45-minute walking classes on Zoom per week for 4 weeks.
Primary Outcome Measure Information:
Title
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
Description
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
Secondary Outcome Measure Information:
Title
Change in minutes of moderate-to-vigorous intensity physical activity (MVPA)/week
Description
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
Title
Proportion of patients achieving guideline-recommended volume of physical activity
Description
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
Title
Change in minutes of sedentary time/week
Description
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
Other Pre-specified Outcome Measures:
Title
Self-reported physical activity
Description
This will be assessed by the validated Exercise as a Vital Sign instrument (Grant et al., 2014).
Time Frame
4 and 12 weeks
Title
Change in weight (kg)
Description
This will be assessed based on reported weights by participants
Time Frame
4 and 12 weeks
Title
Change in blood pressure (mmHg)
Description
This will be assessed based on reported home blood pressure measurements using study-provided automatic blood pressure cuffs.
Time Frame
4 and 12 weeks
Title
Change in resting heart rate (bpm)
Description
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
Title
Self-determination
Description
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
Title
Psychological need satisfaction
Description
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
Title
Well-being
Description
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
Title
Health-related quality of life
Description
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
Title
General satisfaction
Description
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
Title
Likelihood to recommend
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI AND
Stress test (completed within 12 months after diagnosis of MI OR within 5 years prior to enrollment) OR
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.
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)10 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument11
Ability to ambulate independently
Possession of and ability to use a computer and/or smart device with video conferencing capability
Possession of and willing to use a home scale daily.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simin G Lee, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31163980
Citation
Nowbar AN, Gitto M, Howard JP, Francis DP, Al-Lamee R. Mortality From Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005375. doi: 10.1161/CIRCOUTCOMES.118.005375. Epub 2019 Jun 4.
Results Reference
background
PubMed Identifier
21982647
Citation
Lawler PR, Filion KB, Eisenberg MJ. Efficacy of exercise-based cardiac rehabilitation post-myocardial infarction: a systematic review and meta-analysis of randomized controlled trials. Am Heart J. 2011 Oct;162(4):571-584.e2. doi: 10.1016/j.ahj.2011.07.017. Epub 2011 Sep 3.
Results Reference
background
PubMed Identifier
27885060
Citation
Minges KE, Strait KM, Owen N, Dunstan DW, Camhi SM, Lichtman J, Geda M, Dreyer RP, Bueno H, Beltrame JF, Curtis JP, Krumholz HM. Gender differences in physical activity following acute myocardial infarction in adults: A prospective, observational study. Eur J Prev Cardiol. 2017 Jan;24(2):192-203. doi: 10.1177/2047487316679905. Epub 2016 Nov 25.
Results Reference
background
PubMed Identifier
28507059
Citation
Gorczyca AM, Eaton CB, LaMonte MJ, Manson JE, Johnston JD, Bidulescu A, Waring ME, Manini T, Martin LW, Stefanick ML, He K, Chomistek AK. Change in Physical Activity and Sitting Time After Myocardial Infarction and Mortality Among Postmenopausal Women in the Women's Health Initiative-Observational Study. J Am Heart Assoc. 2017 May 15;6(5):e005354. doi: 10.1161/JAHA.116.005354.
Results Reference
background
PubMed Identifier
35175838
Citation
Smith JR, Thomas RJ, Bonikowske AR, Hammer SM, Olson TP. Sex Differences in Cardiac Rehabilitation Outcomes. Circ Res. 2022 Feb 18;130(4):552-565. doi: 10.1161/CIRCRESAHA.121.319894. Epub 2022 Feb 17. Erratum In: Circ Res. 2022 Mar 18;130(6):e22.
Results Reference
background
PubMed Identifier
23166210
Citation
Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012 Dec 18;126(25):3097-137. doi: 10.1161/CIR.0b013e3182776f83. Epub 2012 Nov 19. No abstract available. Erratum In: Circulation. 2014 Apr 22;129(16):e462.
Results Reference
background
PubMed Identifier
24309950
Citation
Grant RW, Schmittdiel JA, Neugebauer RS, Uratsu CS, Sternfeld B. Exercise as a vital sign: a quasi-experimental analysis of a health system intervention to collect patient-reported exercise levels. J Gen Intern Med. 2014 Feb;29(2):341-8. doi: 10.1007/s11606-013-2693-9. Epub 2013 Dec 6.
Results Reference
background
PubMed Identifier
22726453
Citation
Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78.
Results Reference
background
Citation
Wilson PM, Rodgers WM, Loitz CC, Sclme G, Wilson PM. "It's Who I Am … Really!' The Importance of Integrated Regulation in Exercise Contexts. J Appl Biobehav Res. 2006;11(2):79-104.
Results Reference
background
Citation
Wilson PM, Rogers WT, Rodgers WM, Wild TC. The psychological need satisfaction in exercise scale. J Sport Exerc Psychol. 2006;28(3):231-251.
Results Reference
background
PubMed Identifier
25831962
Citation
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
Results Reference
background
PubMed Identifier
10785566
Citation
Failde I, Ramos I. Validity and reliability of the SF-36 Health Survey Questionnaire in patients with coronary artery disease. J Clin Epidemiol. 2000 Apr;53(4):359-65. doi: 10.1016/s0895-4356(99)00175-4.
Results Reference
background
PubMed Identifier
30732582
Citation
Redenius N, Kim Y, Byun W. Concurrent validity of the Fitbit for assessing sedentary behavior and moderate-to-vigorous physical activity. BMC Med Res Methodol. 2019 Feb 7;19(1):29. doi: 10.1186/s12874-019-0668-1.
Results Reference
background
PubMed Identifier
31943970
Citation
Semanik P, Lee J, Pellegrini CA, Song J, Dunlop DD, Chang RW. Comparison of Physical Activity Measures Derived From the Fitbit Flex and the ActiGraph GT3X+ in an Employee Population With Chronic Knee Symptoms. ACR Open Rheumatol. 2020 Jan;2(1):48-52. doi: 10.1002/acr2.11099. Epub 2019 Dec 2.
Results Reference
background
Learn more about this trial
A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
We'll reach out to this number within 24 hrs