Comparison of Conventional and Tele-cardiac Rehabilitation
NCT ID: NCT06614634
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-09-19
2023-12-28
Brief Summary
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Detailed Description
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Both rehabilitation programs lasted for four weeks, with three exercise sessions per week. In the HBCR group, patients underwent supervised exercise sessions in the cardiac rehabilitation (CR) unit, including individualized aerobic and resistance training. Aerobic exercises were based on the patient's peak VO2 from a baseline cardiopulmonary exercise test (CPET), aiming to achieve 60-80% of the maximum heart rate. Resistance training involved the use of elastic bands targeting major muscle groups, with a progressive increase in repetitions based on patient tolerance.
The TCR group received a home-based exercise program that included aerobic and resistance training. Aerobic exercises, such as walking, were performed for 30 minutes, three times a week, monitored via a Polar H9 heart rate device. Patients were instructed to maintain heart rates within the same range as the HBCR group. Resistance exercises were similar to those in the HBCR group, using elastic bands provided at the beginning of the study. Weekly remote follow-ups were conducted via phone calls to assess adherence, review heart rate data, and provide encouragement.
Initial and final evaluations included the CPET, the Coronary Artery Disease-Specific Activity Fear Scale (AKKOR-KAH), and the WHOQOL-BREF Quality of Life Questionnaire. Outcome measures assessed changes in peak oxygen consumption (VO2 max), exercise capacity, quality of life, and fear of activity.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Tele-cardiac rehabilitation group
Patients in the tele-cardiac rehabilitation group initially underwent a similar trial exercise session as those in the hospital-based rehabilitation group. During this session, patients were informed about exercise duration and intensity, using the heart rate monitor (Polar H9) and elastic bands, and transferring data to the web application (Polar Flow web). Subsequently, patients were instructed to perform aerobic and strengthening exercises at home/outdoors at least 3 days a week for four weeks. During the program, the researcher called them once a week for reinforcement. Phone calls included symptom inquiry and encouraging feedback regarding exercise parameters recorded on the Polar H9 website in the previous week. In the second week, patients underwent an interim exercise session under supervision in our CPR unit and a similar face-to-face interview was conducted. The program was concluded at the end of four weeks.
Remotely supervised exercise at home or outdoors
Aerobic and strengthening exercise program at home/outdoors at least three days a week for four weeks using a Polar H9 heart rate monitor and elastic band.
Cardiovascular risk modification
Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.
Phone calls with reinforcement feedback
Calls once a week that include symptom inquiries and encouraging feedback on exercise logs.
Hospital-based rehabilitation group
Participants in the hospital-based rehabilitation group performed aerobic and strengthening exercises under the supervision of a physiotherapist/nurse/research doctor three days a week for four weeks in the cardiopulmonary rehabilitation unit. Aerobic exercise included 30-minute treadmill walking at 60-80% of the peak VO2 value obtained in the cardiopulmonary exercise test. After the end of the aerobic exercise, upper and lower extremity muscle strengthening exercises were performed with warm-up and cool-down periods using medium-tension elastic bands under the supervision of a physiotherapist. At the end of four weeks, the program was terminated and a follow-up evaluation was conducted.
Hospital-based exercise program
The aerobic and strengthening exercise program three days a week for four weeks under supervision in our cardiopulmonary rehabilitation unit.
Cardiovascular risk modification
Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.
Interventions
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Remotely supervised exercise at home or outdoors
Aerobic and strengthening exercise program at home/outdoors at least three days a week for four weeks using a Polar H9 heart rate monitor and elastic band.
Hospital-based exercise program
The aerobic and strengthening exercise program three days a week for four weeks under supervision in our cardiopulmonary rehabilitation unit.
Cardiovascular risk modification
Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.
Phone calls with reinforcement feedback
Calls once a week that include symptom inquiries and encouraging feedback on exercise logs.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of clinically stable coronary artery disease (CAD), defined as stable angina pectoris, a history of myocardial infarction, history of percutaneous coronary intervention, or coronary artery bypass graft surgery.
* Classified as having a low to moderate risk of experiencing a new cardiac event, according to established risk stratification guidelines.
* Possession of a smartphone and reliable internet access at home to facilitate participation in telehealth interventions.
Exclusion Criteria
* Presence of a pacemaker or implantable cardioverter-defibrillator that may interfere with study protocols.
* Hospitalization for any cardiac condition within the last 6 weeks prior to enrollment.
* Evidence of residual coronary artery stenosis necessitating revascularization procedures.
* Classification of heart failure as New York Heart Association (NYHA) Class IV, indicating severe functional limitations.
* Diagnosis of untreated malignancy that could affect participation and outcomes.
* Presence of orthopedic, neurological, or psychiatric disorders that may hinder assessment or engagement in prescribed exercise regimens.
18 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Levent Karataş
M.D.
Principal Investigators
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Ülkü Nesrin Demirsoy, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University Faculty of Medicine
Nihan Burhandağ, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University Faculty of Medicine
Levent Karataş, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University Faculty of Medicine
Locations
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Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, , Turkey (Türkiye)
Countries
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References
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Kraal JJ, Peek N, Van den Akker-Van Marle ME, Kemps HM. Effects of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: short-term results of the FIT@Home study. Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):26-31. doi: 10.1177/2047487314552606.
Amaravathi E, Ramarao NH, Raghuram N, Pradhan B. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52. doi: 10.4103/ijoy.IJOY_57_16.
Ozyemisci-Taskiran O, Demirsoy N, Atan T, Yuksel S, Coskun O, Aytur YK, Tur BS, Karakas M, Turak O, Topal S. Development and Validation of a Scale to Measure Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD). Arch Phys Med Rehabil. 2020 Mar;101(3):479-486. doi: 10.1016/j.apmr.2019.09.001. Epub 2019 Sep 25.
WASSERMAN K, MCILROY MB. DETECTING THE THRESHOLD OF ANAEROBIC METABOLISM IN CARDIAC PATIENTS DURING EXERCISE. Am J Cardiol. 1964 Dec;14:844-52. doi: 10.1016/0002-9149(64)90012-8. No abstract available.
Forman DE, Myers J, Lavie CJ, Guazzi M, Celli B, Arena R. Cardiopulmonary exercise testing: relevant but underused. Postgrad Med. 2010 Nov;122(6):68-86. doi: 10.3810/pgm.2010.11.2225.
Holverda S, Bogaard HJ, Groepenhoff H, Postmus PE, Boonstra A, Vonk-Noordegraaf A. Cardiopulmonary exercise test characteristics in patients with chronic obstructive pulmonary disease and associated pulmonary hypertension. Respiration. 2008;76(2):160-7. doi: 10.1159/000110207. Epub 2007 Oct 25.
Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.
Arena R, Myers J, Abella J, Peberdy MA, Bensimhon D, Chase P, Guazzi M. Development of a ventilatory classification system in patients with heart failure. Circulation. 2007 May 8;115(18):2410-7. doi: 10.1161/CIRCULATIONAHA.107.686576. Epub 2007 Apr 23.
Lauer M, Froelicher ES, Williams M, Kligfield P; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention. Exercise testing in asymptomatic adults: a statement for professionals from the American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention. Circulation. 2005 Aug 2;112(5):771-6. doi: 10.1161/CIRCULATIONAHA.105.166543. Epub 2005 Jul 5.
Batalik L, Dosbaba F, Hartman M, Batalikova K, Spinar J. Benefits and effectiveness of using a wrist heart rate monitor as a telerehabilitation device in cardiac patients: A randomized controlled trial. Medicine (Baltimore). 2020 Mar;99(11):e19556. doi: 10.1097/MD.0000000000019556.
Other Identifiers
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Cardiac telerehab
Identifier Type: -
Identifier Source: org_study_id
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