A Behavioral Science-Enhanced PHysician-led Remote Group Exercise InTervention for Women With Coronary Artery Disease
NCT ID: NCT05611333
Last Updated: 2023-10-23
Study Results
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Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2022-11-02
2023-07-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Musculoskeletal or plantar wounds/injuries
3. Severe mental or cognitive disabilities
4. Inability to speak English
40 Years
80 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Simin G. Lee
Physician
Principal Investigators
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Simin G Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Wilson PM, Rogers WT, Rodgers WM, Wild TC. The psychological need satisfaction in exercise scale. J Sport Exerc Psychol. 2006;28(3):231-251.
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.
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.
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.
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.
Other Identifiers
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2022P002541
Identifier Type: -
Identifier Source: org_study_id
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