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Exercise Prescription in Cardiac Rehabilitation

Study Description
Brief Summary:
Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease. There are two common methods of exercise prescription, an effort based exercise prescription and target heart rate based exercise prescription. The purpose of this research study is to identify the best way to exercise in cardiac rehabilitation. There are three main goals of this study. First, the investigators want to know if an exercise test should be done near the beginning of cardiac rehabilitation. Second, the investigators want to understand what type of exercises should be recommend to patients. Third, the investigators want to understand if a personal heart rate monitor will improve adherence to a target heart rate for exercise. As part of this study, some patients will undergo an exercise stress test on a treadmill to determine a target heart rate. These patients will be given a heart rate goal to use when they exercise. Some patients will be given a personal heart rate monitor to improve adherence.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Myocardial Infarction Coronary Artery Bypass Graft Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range Behavioral: Heart rate monitors Not Applicable

Detailed Description:
Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease that reduces cardiovascular morbidity and mortality, increases quality of life, and is cost-effective. Recent retrospective studies show that higher exercise gains during CR are associated with reduced long-term morbidity and mortality among patients with both coronary artery disease and systolic heart failure. However, it is unclear which methods maximize exercise gains in CR. Recent retrospective studies have suggested that performing stress testing early in CR may allow for better tailoring of an exercise prescription and thus increase exercise gains. In this study, the investigators propose to do a randomized controlled trial of 60 patients at Baystate Medical Center CR, in which two thirds of the patients will undergo exercise testing prior to starting CR. The exercise test will determine the initial target heart rate range (THRR) and will also influence subsequent exercise progression. Additionally, half of the patients undergoing a stress test will receive a personal heart rate monitor to help improve adherence to the exercise prescription and THRR. The primary outcome is to determine feasibility, protocol fidelity, and effect sizes in preparation for a fully powered subsequent trial that will measure the impact of stress testing and a target heart rage range exercise prescription on exercise gain during CR.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Prescription in Cardiac Rehabilitation: A Pilot Randomized Controlled Trial
Actual Study Start Date : June 17, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : September 3, 2020
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control Group Procedures (RPE based exercise)
Patients in the control group will follow standard exercise prescription protocols in CR. Exercise intensity will be guided by the patient's reported rating of perceived exertion (RPE). The modified Borg scale will be used by the patients to determine their RPE. Therefore, a scale of 1-10 will be used. The general goal will be to exercise between intensity level 3 or 4 (i.e. moderate intensity), per current program standards. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise as appropriate. Exercise progression will be guided by RPE and clinical assessment.
Experimental: Exercise Test and Heart Rate Range
Patients randomly assigned to this group will complete a graded exercise test (GXT) per standard protocols. The researchers will obtain the patients peak heart rate from this stress test. Obtaining an accurate peak heart rate will allow for the calculation of a target heart rate range (THRR) using the Karvonen formula. Based upon the Karvonen formula, the THRR will be between 60-80% of the patient's heart rate reserve. The Karvonen formula can be calculated as follows ((peak heart rate - resting heart rate) X % intensity (0.6 or 0.8) + resting heart rate)). An example would be: (155 -75) X (.6) + 75) = 123; ((155 - 75) X (.8) + 75 = 139) THRR: 123 - 139. Patients will then adjust their exercise intensity to match this target heart rate range for the duration of their time in cardiac rehabilitation. Cardiac rehabilitation staff will provide feedback about heart rate when they are able.
 Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.
Experimental: Exercise Test, Heart Rate Range, and Heart Rate Monitor

Patients randomly assigned to this group will also undergo a stress test (GXT) and exercise within a target heart rate range (THRR) during cardiac rehabilitation comparable to second arm of the trial. Additionally, they will receive a personal heart rate monitor (HRM). This monitor will consist of a polar heart rate chest strap and polar watch. Patients will be asked to wear this during cardiac rehabilitation and adjust their own exercise intensity. This will provide continuous feedback to the patient about their heart rate. Cardiac rehabilitation staff will also provide feedback when available.

The investigators are using the heart rate monitors because cardiac rehab staff are not always able to adjust exercise intensity for all patients, and telemetry is not always used.

 Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.

Behavioral: Heart rate monitors
Heart rate monitors (HRM) will be given to half of the patients randomly assigned to exercise stress testing group. Patients will receive a polar heart rate chest strap and polar watch. Patients will be asked to wear both, the chest strap and the watch during cardiac rehabilitation. Ultimately, we hope that the use of HRM is not necessary, but it may be needed to assure that patients in the THHR are able to consistently know their HR and adjust their exercise prescription. This will also increase the likelihood that there is a difference in heart rates between the THRR group from the RPE group.
Outcome Measures
Primary Outcome Measures :
  1. Recruit 60 patients [ Time Frame: One year ]
    The number of patients that signed informed consent to participate in the study

  2. Retain patients for at least 12 exercise sessions of cardiac rehab [ Time Frame: within 3 months of recruitment ]
    The percentage of patients that exercised for at least 12 sessions of cardiac rehab


Secondary Outcome Measures :
  1. Peak exercise capacity at the completion of cardiac rehabilitation [ Time Frame: Within 6 months of study enrollment ]
    Peak VO2 as measured on a maximal cardiopulmonary stress test

  2. Change in functional exercise capacity from baseline to end of cardiac rehab [ Time Frame: Within 6 months of study enrollment ]
    The change in functional exercise capacity as measured in METS as calculated using the online formula, http://www.fedel.com/mets/, obtained from calibrated treadmill speed and incline during usual exercise training workloads.

  3. Adherence to Cardiac Rehabilitation (CR) [ Time Frame: Within 6 months of enrollment ]
    Total number of CR sessions completed

  4. Change in Patient Exercise Confidence [ Time Frame: Within 6 months of enrollment ]
    Patients confidence, fear, and anxiety will be measured using surveys at baseline, after 6 sessions of cardiac rehab, and at the end of cardiac rehab. The confidence ruler is a 0 to 10 scale. A higher score on the confidence survey, indicates a greater level of confidence. A minimum score of 0 and a max score of 10 will be used per question, therefore, patients can receive a minimum score of 0 (low confidence) and a maximum score of 100 (high confidence). Fear and Anxiety will be measured using an anxiety questionnaire. Each question has a scale from 1 to 5 indicting very little fear to very fearful. A lower score on the anxiety scale indicates less anxiety or fear. Patients can receive a score from 6 (very little fear) to 30 (very fearful).

  5. The number of patients with at least one or more adverse events in CR [ Time Frame: Within 6 months of enrollment ]
    The percentage of patients that have an adverse clinical event that precludes or stops exercise during cardiac rehabilitation. The adverse event is determined by the opinion of the treating clinician, the patient was unable to start or continue exercising based on one or more of the following subcategories; high or low blood pressure, dyspnea, tachycardia, or chest pain as defined by the treating clinician who stopped or precluded exercise.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are referred with an eligible diagnosis to CR.
  • Patients with myocardial infarction, percutaneous coronary intervention, or bypass surgery

Exclusion Criteria:

  • Permanent Atrial fibrillation, as this would interfere with using a target heart rate range during cardiac rehabilitation.
  • Patients with pacemakers, as the polar heart rate monitor interferes with pacing lines on the telemetry system.
  • Stable angina, as chest pain could become a limiting factor as exercise training progresses, rather than using target heart rates.
  • Patients with high risk unrevascularized coronary artery disease including left main coronary disease >60% or proximal left anterior descending artery (LAD) >80%, per the discretion of the medical director.
  • Patients with heart transplant or left-ventricular assist device, as heart rates can be inaccurate and difficult to measure.
  • Patients who plan to attend fewer than 12 sessions of CR, for reasons that might include need to return to work, high copays, transportation, lack of insurance, or lack of interest in the program.
  • Patients who join the Baystate CR program after having completed more than 3 sessions of CR at a different CR program.
  • Major orthopedic limitations to exercise, such as history of amputation or exercise-limiting joint pain, or inability to walk on a treadmill, because all patients will have to complete a stress test on a treadmill and objective data collected during CR will be recorded during treadmill exercise.
  • Patients who plan to undergo a clinically indicated stress test in the next 3 months as this would potentially interfere with the exercise prescription in the control group.
  • Any elective hospitalization or revascularization procedure (such as PCI or CABG) that are planned to occur in the next 3 months. These could interrupt exercise training or change target heart rate ranges.
  • Any other condition in which exercise training or exercise testing would be contraindicated such as severe uncontrolled hypertension, diabetes, arrhythmia, or severe valvular disease, as determined by the Medical Director of Cardiac Rehabilitation.
  • Any other condition that would prohibit adherence to study protocols, such as active drug use, or untreated mental health conditions that would interfere with following instructions.
  • Patients judged to be at very high or high-risk of early drop-out, per current program risk stratification
Contacts and Locations

Locations
Layout table for location information
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Springfield College
Investigators
Layout table for investigator information
Study Director: Peter K Lindenauer, MD Baystate Medical Center
Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE June 17, 2019
Actual Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Recruit 60 patients [ Time Frame: One year ]
    The number of patients that signed informed consent to participate in the study
  • Retain patients for at least 12 exercise sessions of cardiac rehab [ Time Frame: within 3 months of recruitment ]
    The percentage of patients that exercised for at least 12 sessions of cardiac rehab
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Peak exercise capacity at the completion of cardiac rehabilitation [ Time Frame: Within 6 months of study enrollment ]
    Peak VO2 as measured on a maximal cardiopulmonary stress test
  • Change in functional exercise capacity from baseline to end of cardiac rehab [ Time Frame: Within 6 months of study enrollment ]
    The change in functional exercise capacity as measured in METS as calculated using the online formula, http://www.fedel.com/mets/, obtained from calibrated treadmill speed and incline during usual exercise training workloads.
  • Adherence to Cardiac Rehabilitation (CR) [ Time Frame: Within 6 months of enrollment ]
    Total number of CR sessions completed
  • Change in Patient Exercise Confidence [ Time Frame: Within 6 months of enrollment ]
    Patients confidence, fear, and anxiety will be measured using surveys at baseline, after 6 sessions of cardiac rehab, and at the end of cardiac rehab. The confidence ruler is a 0 to 10 scale. A higher score on the confidence survey, indicates a greater level of confidence. A minimum score of 0 and a max score of 10 will be used per question, therefore, patients can receive a minimum score of 0 (low confidence) and a maximum score of 100 (high confidence). Fear and Anxiety will be measured using an anxiety questionnaire. Each question has a scale from 1 to 5 indicting very little fear to very fearful. A lower score on the anxiety scale indicates less anxiety or fear. Patients can receive a score from 6 (very little fear) to 30 (very fearful).
  • The number of patients with at least one or more adverse events in CR [ Time Frame: Within 6 months of enrollment ]
    The percentage of patients that have an adverse clinical event that precludes or stops exercise during cardiac rehabilitation. The adverse event is determined by the opinion of the treating clinician, the patient was unable to start or continue exercising based on one or more of the following subcategories; high or low blood pressure, dyspnea, tachycardia, or chest pain as defined by the treating clinician who stopped or precluded exercise.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Prescription in Cardiac Rehabilitation
Official Title  ICMJE Exercise Prescription in Cardiac Rehabilitation: A Pilot Randomized Controlled Trial
Brief Summary Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease. There are two common methods of exercise prescription, an effort based exercise prescription and target heart rate based exercise prescription. The purpose of this research study is to identify the best way to exercise in cardiac rehabilitation. There are three main goals of this study. First, the investigators want to know if an exercise test should be done near the beginning of cardiac rehabilitation. Second, the investigators want to understand what type of exercises should be recommend to patients. Third, the investigators want to understand if a personal heart rate monitor will improve adherence to a target heart rate for exercise. As part of this study, some patients will undergo an exercise stress test on a treadmill to determine a target heart rate. These patients will be given a heart rate goal to use when they exercise. Some patients will be given a personal heart rate monitor to improve adherence.
Detailed Description Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease that reduces cardiovascular morbidity and mortality, increases quality of life, and is cost-effective. Recent retrospective studies show that higher exercise gains during CR are associated with reduced long-term morbidity and mortality among patients with both coronary artery disease and systolic heart failure. However, it is unclear which methods maximize exercise gains in CR. Recent retrospective studies have suggested that performing stress testing early in CR may allow for better tailoring of an exercise prescription and thus increase exercise gains. In this study, the investigators propose to do a randomized controlled trial of 60 patients at Baystate Medical Center CR, in which two thirds of the patients will undergo exercise testing prior to starting CR. The exercise test will determine the initial target heart rate range (THRR) and will also influence subsequent exercise progression. Additionally, half of the patients undergoing a stress test will receive a personal heart rate monitor to help improve adherence to the exercise prescription and THRR. The primary outcome is to determine feasibility, protocol fidelity, and effect sizes in preparation for a fully powered subsequent trial that will measure the impact of stress testing and a target heart rage range exercise prescription on exercise gain during CR.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Coronary Artery Bypass Graft
Intervention  ICMJE
  • Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
    Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.
  • Behavioral: Heart rate monitors
    Heart rate monitors (HRM) will be given to half of the patients randomly assigned to exercise stress testing group. Patients will receive a polar heart rate chest strap and polar watch. Patients will be asked to wear both, the chest strap and the watch during cardiac rehabilitation. Ultimately, we hope that the use of HRM is not necessary, but it may be needed to assure that patients in the THHR are able to consistently know their HR and adjust their exercise prescription. This will also increase the likelihood that there is a difference in heart rates between the THRR group from the RPE group.
Study Arms  ICMJE
  • No Intervention: Control Group Procedures (RPE based exercise)
    Patients in the control group will follow standard exercise prescription protocols in CR. Exercise intensity will be guided by the patient's reported rating of perceived exertion (RPE). The modified Borg scale will be used by the patients to determine their RPE. Therefore, a scale of 1-10 will be used. The general goal will be to exercise between intensity level 3 or 4 (i.e. moderate intensity), per current program standards. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise as appropriate. Exercise progression will be guided by RPE and clinical assessment.
  • Experimental: Exercise Test and Heart Rate Range
    Patients randomly assigned to this group will complete a graded exercise test (GXT) per standard protocols. The researchers will obtain the patients peak heart rate from this stress test. Obtaining an accurate peak heart rate will allow for the calculation of a target heart rate range (THRR) using the Karvonen formula. Based upon the Karvonen formula, the THRR will be between 60-80% of the patient's heart rate reserve. The Karvonen formula can be calculated as follows ((peak heart rate - resting heart rate) X % intensity (0.6 or 0.8) + resting heart rate)). An example would be: (155 -75) X (.6) + 75) = 123; ((155 - 75) X (.8) + 75 = 139) THRR: 123 - 139. Patients will then adjust their exercise intensity to match this target heart rate range for the duration of their time in cardiac rehabilitation. Cardiac rehabilitation staff will provide feedback about heart rate when they are able.
    Intervention: Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
  • Experimental: Exercise Test, Heart Rate Range, and Heart Rate Monitor

    Patients randomly assigned to this group will also undergo a stress test (GXT) and exercise within a target heart rate range (THRR) during cardiac rehabilitation comparable to second arm of the trial. Additionally, they will receive a personal heart rate monitor (HRM). This monitor will consist of a polar heart rate chest strap and polar watch. Patients will be asked to wear this during cardiac rehabilitation and adjust their own exercise intensity. This will provide continuous feedback to the patient about their heart rate. Cardiac rehabilitation staff will also provide feedback when available.

    The investigators are using the heart rate monitors because cardiac rehab staff are not always able to adjust exercise intensity for all patients, and telemetry is not always used.

    Interventions:
    • Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
    • Behavioral: Heart rate monitors
Publications *
  • Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2. Review. Update in: Cochrane Database Syst Rev. 2016;1:CD001800.
  • Brawner CA, Abdul-Nour K, Lewis B, Schairer JR, Modi SS, Kerrigan DJ, Ehrman JK, Keteyian SJ. Relationship Between Exercise Workload During Cardiac Rehabilitation and Outcomes in Patients With Coronary Heart Disease. Am J Cardiol. 2016 Apr 15;117(8):1236-41. doi: 10.1016/j.amjcard.2016.01.018. Epub 2016 Jan 28.
  • Keteyian SJ, Leifer ES, Houston-Miller N, Kraus WE, Brawner CA, O'Connor CM, Whellan DJ, Cooper LS, Fleg JL, Kitzman DW, Cohen-Solal A, Blumenthal JA, Rendall DS, Piña IL; HF-ACTION Investigators. Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol. 2012 Nov 6;60(19):1899-905. doi: 10.1016/j.jacc.2012.08.958. Epub 2012 Oct 10.
  • Brawner CA, Al-Mallah MH, Ehrman JK, Qureshi WT, Blaha MJ, Keteyian SJ. Change in Maximal Exercise Capacity Is Associated With Survival in Men and Women. Mayo Clin Proc. 2017 Mar;92(3):383-390. doi: 10.1016/j.mayocp.2016.12.016. Epub 2017 Feb 6.
  • Keteyian SJ, Kerrigan DJ, Ehrman JK, Brawner CA. Exercise Training Workloads Upon Exit From Cardiac Rehabilitation in Men and Women: THE HENRY FORD HOSPITAL EXPERIENCE. J Cardiopulm Rehabil Prev. 2017 Jul;37(4):257-261. doi: 10.1097/HCR.0000000000000210.
  • Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001 Sep 20;345(12):892-902. Review.
  • Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. Epub 2007 Sep 24.
  • Pack QR, Squires RW, Lopez-Jimenez F, Lichtman SW, Rodriguez-Escudero JP, Zysek VN, Thomas RJ. The current and potential capacity for cardiac rehabilitation utilization in the United States. J Cardiopulm Rehabil Prev. 2014 Sep-Oct;34(5):318-26. doi: 10.1097/HCR.0000000000000076. Review.
  • Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044. Review.
  • Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002 Mar 14;346(11):793-801.
  • Keteyian SJ, Brawner CA, Savage PD, Ehrman JK, Schairer J, Divine G, Aldred H, Ophaug K, Ades PA. Peak aerobic capacity predicts prognosis in patients with coronary heart disease. Am Heart J. 2008 Aug;156(2):292-300. doi: 10.1016/j.ahj.2008.03.017. Epub 2008 May 22.
  • Pack QR, Bauldoff G, Lichtman SW, Buckley M, Eichenauer K, Gavic A, Garvey C, King ML; American Association of Cardiovascular and Pulmonary Rehabilitation Quality of Care Committee. Prioritization, Development, and Validation of American Association of Cardiovascular and Pulmonary Rehabilitation Performance Measures. J Cardiopulm Rehabil Prev. 2018 Jul;38(4):208-214. doi: 10.1097/HCR.0000000000000358.
  • Soga Y, Yokoi H, Ando K, Shirai S, Sakai K, Kondo K, Goya M, Iwabuchi M, Nobuyoshi M. Safety of early exercise training after elective coronary stenting in patients with stable coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):230-4. doi: 10.1097/HJR.0b013e3283359c4e.
  • Iliou MC, Pavy B, Martinez J, Corone S, Meurin P, Tuppin P; CRS investigators and GERS (Groupe Exercice Réadaptation, Sport) from French Society of Cardiology. Exercise training is safe after coronary stenting: a prospective multicentre study. Eur J Prev Cardiol. 2015 Jan;22(1):27-34. doi: 10.1177/2047487313505819. Epub 2013 Sep 20.
  • Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34.
  • Hamm LF. Point: High quality or just average - the need for exercise testing before cardiac rehabilitation. Journal of Clinical Exercise Physiology. 2013;2:42-45
  • McConnell TR. Counterpoint: All patients do no need an exercise test before starting cardiac rehabilitation. Journal of Clinical Exercise Physiology. 2013;2:45-48
  • Scheinowitz M, Harpaz D. Safety of cardiac rehabilitation in a medically supervised, community-based program. Cardiology. 2005;103(3):113-7. Epub 2005 Jan 19.
  • Goto Y, Sumida H, Ueshima K, Adachi H, Nohara R, Itoh H. Safety and implementation of exercise testing and training after coronary stenting in patients with acute myocardial infarction. Circ J. 2002 Oct;66(10):930-6.
  • Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2021) 		48
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		60
Actual Study Completion Date  ICMJE September 3, 2020
Actual Primary Completion Date March 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are referred with an eligible diagnosis to CR.
  • Patients with myocardial infarction, percutaneous coronary intervention, or bypass surgery

Exclusion Criteria:

  • Permanent Atrial fibrillation, as this would interfere with using a target heart rate range during cardiac rehabilitation.
  • Patients with pacemakers, as the polar heart rate monitor interferes with pacing lines on the telemetry system.
  • Stable angina, as chest pain could become a limiting factor as exercise training progresses, rather than using target heart rates.
  • Patients with high risk unrevascularized coronary artery disease including left main coronary disease >60% or proximal left anterior descending artery (LAD) >80%, per the discretion of the medical director.
  • Patients with heart transplant or left-ventricular assist device, as heart rates can be inaccurate and difficult to measure.
  • Patients who plan to attend fewer than 12 sessions of CR, for reasons that might include need to return to work, high copays, transportation, lack of insurance, or lack of interest in the program.
  • Patients who join the Baystate CR program after having completed more than 3 sessions of CR at a different CR program.
  • Major orthopedic limitations to exercise, such as history of amputation or exercise-limiting joint pain, or inability to walk on a treadmill, because all patients will have to complete a stress test on a treadmill and objective data collected during CR will be recorded during treadmill exercise.
  • Patients who plan to undergo a clinically indicated stress test in the next 3 months as this would potentially interfere with the exercise prescription in the control group.
  • Any elective hospitalization or revascularization procedure (such as PCI or CABG) that are planned to occur in the next 3 months. These could interrupt exercise training or change target heart rate ranges.
  • Any other condition in which exercise training or exercise testing would be contraindicated such as severe uncontrolled hypertension, diabetes, arrhythmia, or severe valvular disease, as determined by the Medical Director of Cardiac Rehabilitation.
  • Any other condition that would prohibit adherence to study protocols, such as active drug use, or untreated mental health conditions that would interfere with following instructions.
  • Patients judged to be at very high or high-risk of early drop-out, per current program risk stratification
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925493
Other Study ID Numbers  ICMJE BH-19-087
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 12 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement
Responsible Party Quinn Pack, MD, MSc, Baystate Medical Center
Study Sponsor  ICMJE Baystate Medical Center
Collaborators  ICMJE Springfield College
Investigators  ICMJE
Study Director: Peter K Lindenauer, MD Baystate Medical Center
PRS Account Baystate Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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