Telerehabilitation in Coronary Heart Disease

NCT ID: NCT02047942

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-08-31

Brief Summary

Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage in enough physical activity to obtain benefits or in the long-term struggle to maintain a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on health related physical fitness. One strategy might be the use of home-based training in combination of telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical fitness. It is hypothesized that patients randomized to a home-based training program with telemonitoring guidance will demonstrate higher levels of physical activity at one year of follow-up, resulting in higher levels of physical fitness, compared to patients who have been enrolled to the supervised center-based cardiac rehabilitation program or control group. Ninety patients will be randomized to Home-based training, a center-based cardiac rehabilitation program or an advice only group (= control group). Assessment will be performed at baseline, immediately at completion of the intervention and at one-year of follow-up and will include measurements of exercise tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial function, health-related quality.

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)); Myocardial Infarction; Percutaneous Transluminal Cutting Balloon Angioplasty of Popliteal Vein Using Fluoroscopic Guidance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Center-based cardiac rehabilitation

Patients randomized to the center-based training group will continue their training sessions at the outpatient clinics of UZ Leuven under direct supervision of physical therapists

Group Type: ACTIVE_COMPARATOR

Center-based cardiac rehabilitation

Intervention Type: BEHAVIORAL

Home-based training with telemonitoring guidance

Patients will receive an patient-tailored exercise prescription and will be asked to perform the exercise sessions in their home environment wearing heart rate monitors. Training data will be accessed by the research group on weekly basis in order to keep a record of frequency; duration and intensity of the sessions. Feedback will be given weekly to every patient.

Group Type: EXPERIMENTAL

Home-based training with telemonitoring guidance

Intervention Type: BEHAVIORAL

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Center-based cardiac rehabilitation

Intervention Type: BEHAVIORAL

Home-based training with telemonitoring guidance

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with CAD (post-PCI, post-MI, post-CABG)
• Patients on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 6 weeks
• Patients have successfully completed the 3 month ambulatory cardiac rehabilitation in hospital program
• 39 yrs < age < 76 years
• access to internet facilities or PC at home

Exclusion Criteria

• Significant undercurrent illness last 6 weeks
• Known severe ventricular arrhythmia with functional or prognostic significance; significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at screening or heart disease that limits exercise
• Co-morbidity that may significantly influence one-year prognosis
• Functional of mental disability that may limit exercise

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Véronique Cornelissen

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

References

Avila A, Claes J, Buys R, Azzawi M, Vanhees L, Cornelissen V. Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness? Eur J Prev Cardiol. 2020 Mar;27(4):367-377. doi: 10.1177/2047487319892201. Epub 2019 Dec 1.

Reference Type: DERIVED

PMID: 31787026 (View on PubMed)

Avila A, Claes J, Goetschalckx K, Buys R, Azzawi M, Vanhees L, Cornelissen V. Home-Based Rehabilitation With Telemonitoring Guidance for Patients With Coronary Artery Disease (Short-Term Results of the TRiCH Study): Randomized Controlled Trial. J Med Internet Res. 2018 Jun 22;20(6):e225. doi: 10.2196/jmir.9943.

Reference Type: DERIVED

PMID: 29934286 (View on PubMed)

Other Identifiers

MOVE-AGE_09_2013

Identifier Type: -

Identifier Source: org_study_id