Comparison of Conventional and Tele-cardiac Rehabilitation

NCT06614634 | Completed

• 1 other identifier: Cardiac telerehab
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effects of tele-cardiac rehabilitation (TCR) and hospital-based cardiac rehabilitation (HBCR) on functional capacity (maximum oxygen consumption), fear of activity and quality of life in patients with coronary artery disease. CAD). The rehabilitation program included patient-specific aerobic and peripheral muscle strengthening exercises for four weeks and 3 sessions per week. While the HBCR group performed the exercise program under supervision in the cardiac rehabilitation (CR) unit, the TCR group performed the exercise program at home/outdoors using a Polar H9 heart rate monitor and elastic band.

Conditions

Coronary Artery Disease; Cardiac Rehabilitation; Telecardiac Rehabilitation; Aerobic Exercise

Keywords

Cardiac rehabilitation; Telerehabilitation; Coronary artery disease; Tele-cardiac rehabilitation; Fear of activity

Outcome Measures

Primary Outcomes (2)

• World Health Organization Quality of Life Scale-BREF score

  This scale is used for a brief assessment of the quality of life in routine clinical practice, large-scale epidemiological studies, or clinical trials. It comprises 27 questions that evaluate general health status, physical health, psychological status, social relations and environmental issues sub-titles. Each question receives an answer corresponding to 1-5 points. The percentages of the scores obtained from each sub-title allow us to make a quantitative interpretation of domains of the quality of life. Increased scores represent higher life quality.

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Maximum oxygen consumption (VO₂ max)

  It is the highest amount of oxygen that patients can consume during incremental aerobic exercise and is considered the best indicator of exercise capacity.

  From enrollment day to the end of the rehabilitation program at 4 weeks

Secondary Outcomes (6)

• Double-product at the 11. minute of modified Bruce exercise test

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Oxygen (O₂) pulse at maximal exercise

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Carbon dioxide respiratory equivalent (VE/VCO₂)

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Exercise time at which Ventilation Anaerobic Threshold (VAT) is reached

  From enrollment day to the end of the rehabilitation program at 4 weeks

• First-Minute Heart Rate Recovery

  From enrollment day to the end of the rehabilitation program at 4 weeks

Study Arms (2)

Tele-cardiac rehabilitation group

EXPERIMENTAL

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.

Other: Remotely supervised exercise at home or outdoors; Behavioral: Cardiovascular risk modification; Other: Phone calls with reinforcement feedback

Hospital-based rehabilitation group

ACTIVE COMPARATOR

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.

Other: Hospital-based exercise program; Behavioral: Cardiovascular risk modification

Interventions

Remotely supervised exercise at home or outdoors OTHER

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.

Tele-cardiac rehabilitation group

Hospital-based exercise program OTHER

The aerobic and strengthening exercise program three days a week for four weeks under supervision in our cardiopulmonary rehabilitation unit.

Hospital-based rehabilitation group

Cardiovascular risk modification BEHAVIORAL

Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.

Hospital-based rehabilitation group; Tele-cardiac rehabilitation group

Phone calls with reinforcement feedback OTHER

Calls once a week that include symptom inquiries and encouraging feedback on exercise logs.

Tele-cardiac rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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.

You may not qualify if:

• Presence of severe ventricular arrhythmias during low to moderate exercise intensity or a documented history of myocardial ischemia, unstable angina, or abnormal exercise test results during initial evaluation.
• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 25354951 BACKGROUND

• 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.

  PMID: 29343930 BACKGROUND

• 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.

  PMID: 31562874 BACKGROUND

• 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.

  PMID: 14232808 BACKGROUND

• 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.

  PMID: 21084784 BACKGROUND

• 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.

  PMID: 17960052 BACKGROUND

• 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.

  PMID: 17989266 BACKGROUND

• 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.

  PMID: 17452607 BACKGROUND

• 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.

  PMID: 15998671 BACKGROUND

• 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.

  PMID: 32176113 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ülkü Nesrin Demirsoy, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Nihan Burhandağ, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Levent Karataş, MD

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Patients with coronary artery disease who met the inclusion criteria were allocated into hospital-based and tele-cardiac rehabilitation groups.

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: September 19, 2022
• Primary Completion: November 16, 2023
• Study Completion: December 28, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)