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Coronary Artery DiseaseNCT06614634

Comparison of Conventional and Tele-cardiac Rehabilitation

A study testing Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Cardiovascular risk modification in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Cardiovascular risk modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Sep 2022to 28 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University Hospital, Department of Physical Medicine and Rehabilitation

    Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Remotely supervised exercise at home or outdoors, Hospital-based exercise program, Cardiovascular risk modification, Phone calls with reinforcement feedback
Keywords
Cardiac rehabilitation, Telerehabilitation, Coronary artery disease, Tele-cardiac rehabilitation, Fear of activity
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remotely supervised exercise at home or outdoorsOther

    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 programOther

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

  • Cardiovascular risk modificationBehavioural

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

  • Phone calls with reinforcement feedbackOther

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

Study groups in NCT06614634
Study groupRoleWhat they receive
Tele-cardiac rehabilitation groupExperimentalPatients 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.
Receives: Other: Remotely supervised exercise at home or outdoors; Behavioral: Cardiovascular risk modification; Other: Phone calls with reinforcement feedback
Hospital-based rehabilitation groupActive comparatorParticipants 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.
Receives: Other: Hospital-based exercise program; Behavioral: Cardiovascular risk modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (6)

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

    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.

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

  2. Oxygen (O₂) pulse at maximal exercise

    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.

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

  3. Carbon dioxide respiratory equivalent (VE/VCO₂)

    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.

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

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

    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.

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

  5. First-Minute Heart Rate Recovery

    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.

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

  6. Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD) score

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start19 Sep 2022
  3. Primary completion16 Nov 2023
  4. Study completion28 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients with coronary artery disease who met the inclusion criteria were allocated into hospital-based and tele-cardiac rehabilitation groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614634
Sponsor's protocol ID
Cardiac telerehab
Status last verified
Sep 2024
First submitted
24 Sep 2024
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25354951

  • 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.

    PubMed 29343930

  • 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.

    PubMed 31562874

  • 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.

    PubMed 14232808

  • 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.

    PubMed 21084784

  • 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.

    PubMed 17960052

  • 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.

    PubMed 17989266

  • 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.

    PubMed 17452607

  • 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.

    PubMed 15998671

  • 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.

    PubMed 32176113

Questions about this trial

What is this clinical trial studying?

A study testing Remotely supervised exercise at home or outdoors, Hospital-based exercise program and Cardiovascular risk modification in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

World Health Organization Quality of Life Scale-BREF score (time frame: From enrollment day to the end of the rehabilitation program at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06614634, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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