Comparison of Conventional and Tele-cardiac Rehabilitation

September 24, 2024 updated by: Levent Karataş, Gazi University

Comparison of Center-Based and Tele Cardiac Rehabilitation on Functional Capacity, Quality of Life, and Fear of Activity in Coronary Artery Disease: A Patient-Preferred, Controlled, Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, patient-preference, controlled study aimed to investigate the comparative effects of tele-cardiac rehabilitation (TCR) and hospital-based cardiac rehabilitation (HBCR) on functional capacity, fear of activity, and quality of life in patients with coronary artery disease (CAD). The study was conducted between February 2022 and May 2024 at the university's Physical Medicine and Rehabilitation Department. Patients were enrolled based on specific inclusion and exclusion criteria, including stable CAD and adequate technological access for TCR participation. The study design allowed participants to choose between TCR and HBCR after receiving information about both programs, reflecting real-life clinical decision-making scenarios.

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Behavioral: Cardiovascular risk modification
Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.
Other: Phone calls with reinforcement feedback
Calls once a week that include symptom inquiries and encouraging feedback on exercise logs.
Active Comparator: 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.
Behavioral: Cardiovascular risk modification
Psychosocial support for physical activity counselling, heart-healthy diet, referral for smoking cessation and stress management.
Other: Hospital-based exercise program
The aerobic and strengthening exercise program three days a week for four weeks under supervision in our cardiopulmonary rehabilitation unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life Scale-BREF score
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
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)
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-product at the 11. minute of modified Bruce exercise test
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Double-product is obtained by multiplying heart rate and systolic blood pressure at a time point of exercise. It gradually increases as the workload increases during exercise. Double-product is an indirect indicator of myocardial oxygen demand. In this study a specific time point, 11. minute of the modified Bruce exercise test was addressed. There were two reasons for this. First, most patients pass the ventilatory anaerobic threshold between the 9. to 12. minutes of the modified Bruce testing protocol. The other reason is to compare the double product value at a similar workload before and after the rehabilitation program.
From enrollment day to the end of the rehabilitation program at 4 weeks
Oxygen (O₂) pulse at maximal exercise
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
The oxygen pulse expresses the volume of oxygen expelled from the ventricles in each heartbeat. It is calculated by dividing the amount of oxygen consumed in one minute by the heart rate, that is, by the formula VO₂/heart rate. Its unit is expressed as ml/beat. This ratio is equal to the product of the stroke volume and the arteriovenous oxygen difference. Therefore, it reflects the change in stroke volume and the oxygen utilization capacity of the muscles during exercise.
From enrollment day to the end of the rehabilitation program at 4 weeks
Carbon dioxide respiratory equivalent (VE/VCO₂)
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
The respiratory equivalent of carbon dioxide is expressed as VE/VCO₂ and is the ratio of the current minute ventilation (VE) to the carbon dioxide production (VCO₂) during incremental aerobic exercise. It is the amount of breathing required to remove the produced CO₂. It represents dead space ventilation and increases in patients with lung diseases such as heart failure and pulmonary hypertension.
From enrollment day to the end of the rehabilitation program at 4 weeks
Exercise time at which Ventilation Anaerobic Threshold (VAT) is reached
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks

The ventilatory anaerobic threshold (VAT) refers to the point during incremental exercise at which ventilation increases disproportionately to oxygen consumption (VO₂) due to a rise in carbon dioxide (CO₂) production. This marks the transition from predominantly aerobic metabolism, where oxygen is used to produce energy, to increased anaerobic metabolism, where the body starts relying more on non-oxygen-dependent processes for energy production.

As exercise intensity increases, the muscles begin to produce more lactate. When the production of lactate exceeds the body's ability to clear it efficiently, it starts to accumulate in the bloodstream. To buffer the acid produced by lactate, the body produces more CO₂, leading to a corresponding increase in breathing rate (ventilation) to eliminate the excess CO₂. In this study, the time point to achieve VAT in the modified Bruce exercise test protocol was recorded.
From enrollment day to the end of the rehabilitation program at 4 weeks
First-Minute Heart Rate Recovery
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
Heart rate recovery (HRR) refers to the rate at which the heart rate declines following the cessation of exercise, reflecting the balance of autonomic nervous system function, specifically the reactivation of parasympathetic (vagal) tone and withdrawal of sympathetic stimulation. In this study, HRR was assessed as the reduction in heart rate within the first minute of recovery after maximal exertion during exercise testing. A faster HRR is generally considered a marker of superior cardiovascular fitness and autonomic function. Conversely, impaired HRR, particularly a decline of fewer than 12 beats per minute in the first minute post-exercise, has been strongly associated with increased cardiovascular and all-cause mortality, as highlighted in numerous studies. This makes HRR a valuable prognostic tool in assessing long-term outcomes in patients with cardiovascular disease.
From enrollment day to the end of the rehabilitation program at 4 weeks
Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD) score
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
FACT-CAD is a scale used to measure fear of activity in patients with CAD. It consists of 21 questions that evaluate fear of activity and behavioural changes in patients with CAD. Each question receives an answer as ''always, often, sometimes, very rarely, never''. The data obtained allow us to comment on the patient's post-cardiac event behavioural changes and fear of activity. A higher score represents an increased fear of activity.
From enrollment day to the end of the rehabilitation program at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Levent Karataş, MD, Gazi university faculty of medicine
  • Principal Investigator: Ülkü Nesrin Demirsoy, MD, Gazi university faculty of medicine
  • Principal Investigator: Nihan Burhandağ, MD, Gazi university faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiac telerehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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