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OpenTrials
Completed

NCT Number: NCT02047942

Telerehabilitation in Coronary Heart Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Center-based cardiac rehabilitation

Behavioral

Home-based training with telemonitoring guidance

Behavioral

Primary outcomes

  1. exercise tolerance

    Time frame: 1 year

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

  2. exercise tolerance

    Time frame: 12 weeks

    comparison of evolution of exercise tolerance from baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Hasselt University
  • Jessa Hospital

Registry information

Official study title

A Randomized Controlled Trial Comparing Home-based Training With Telemonitoring Guidance Versus Center-based Cardiac Rehabilitation in Patients With Coronary Heart Disease: the TRiCH-study

Acronym: TRiCH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2014
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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