Telerehabilitation in Coronary Heart Disease

NCT02047942 | Completed

• 1 other identifier: MOVE-AGE_09_2013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• exercise tolerance

  comparison of evolution of exercise tolerance from baseline to one-year

  1 year

• exercise tolerance

  comparison of evolution of exercise tolerance from baseline to 12 weeks

  12 weeks

Study Arms (3)

Center-based cardiac rehabilitation

ACTIVE COMPARATOR

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

Behavioral: Center-based cardiac rehabilitation

Home-based training with telemonitoring guidance

EXPERIMENTAL

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.

Behavioral: Home-based training with telemonitoring guidance

Control

NO INTERVENTION

Interventions

Center-based cardiac rehabilitation BEHAVIORAL

Center-based cardiac rehabilitation

Home-based training with telemonitoring guidance BEHAVIORAL

Home-based training with telemonitoring guidance

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• yrs \< age \< 76 years
• access to internet facilities or PC at home

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Jessa Hospital: collaborator
• Hasselt University: collaborator

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

Related Publications (2)

• 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.

  PMID: 31787026 DERIVED

• 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.

  PMID: 29934286 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

BE (1)