Exercise Prescription in Cardiac Rehabilitation

Myocardial Infarction Clinical Trial

Official title:

Exercise Prescription in Cardiac Rehabilitation: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925493
• Other study ID #: BH-19-087
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: September 3, 2020

Study information

• Verified date: January 2021
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 3, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Baystate Medical Center	Springfield College

Country where clinical trial is conducted

United States, 

References & Publications (20)

Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001 Sep 20;345(12):892-902. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

McConnell TR. Counterpoint: All patients do no need an exercise test before starting cardiac rehabilitation. Journal of Clinical Exercise Physiology. 2013;2:45-48

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruit 60 patients	The number of patients that signed informed consent to participate in the study	One year
Primary	Retain patients for at least 12 exercise sessions of cardiac rehab	The percentage of patients that exercised for at least 12 sessions of cardiac rehab	within 3 months of recruitment
Secondary	Peak exercise capacity at the completion of cardiac rehabilitation	Peak VO2 as measured on a maximal cardiopulmonary stress test	Within 6 months of study enrollment
Secondary	Change in functional exercise capacity from baseline to end of cardiac rehab	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.	Within 6 months of study enrollment
Secondary	Adherence to Cardiac Rehabilitation (CR)	Total number of CR sessions completed	Within 6 months of enrollment
Secondary	Change in Patient Exercise Confidence	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).	Within 6 months of enrollment
Secondary	The number of patients with at least one or more adverse events in CR	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.	Within 6 months of enrollment