- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047942
Telerehabilitation in Coronary Heart Disease (TRiCH)
June 20, 2019 updated by: Véronique Cornelissen, KU Leuven
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
-
Leuven, Belgium, 3001
- KU Leuven
-
-
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
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
ACTIVE_COMPARATOR: 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
|
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exercise tolerance
Time Frame: 1 year
|
comparison of evolution of exercise tolerance from baseline to one-year
|
1 year
|
exercise tolerance
Time Frame: 12 weeks
|
comparison of evolution of exercise tolerance from baseline to 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
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)
February 1, 2014
Primary Completion (ACTUAL)
August 1, 2017
Study Completion (ACTUAL)
August 1, 2017
Study Registration Dates
First Submitted
January 27, 2014
First Submitted That Met QC Criteria
January 27, 2014
First Posted (ESTIMATE)
January 28, 2014
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOVE-AGE_09_2013
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.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
Clinical Trials on Center-based cardiac rehabilitation
-
Université de SherbrookeActive, not recruiting
-
Mayo ClinicJohns Hopkins University; University of California, Irvine; University of Mississippi...Not yet recruitingCardiovascular Diseases | Telemedicine | Cardiac EventUnited States
-
Mayo ClinicNational Institute of Nursing Research (NINR)RecruitingHeart Failure | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Stable Angina Pectoris | Acute Myocardial InfarctionUnited States
-
Federico II UniversityCompletedAcute Myocardial InfarctionItaly
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedCardiovascular Diseases | Cardiac Risk FactorsBrazil
-
University of ChesterUniversity Hospitals of Derby and Burton NHS Foundation TrustCompletedCardiovascular DiseasesUnited Kingdom
-
Universidade do PortoCentro Hospitalar de Vila Nova de Gaia/Espinho; Research Center in Physical...CompletedCoronary Artery DiseasePortugal
-
Maxima Medical CenterCompletedMyocardial Infarction | Acute Coronary SyndromeNetherlands
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingCardiovascular Diseases | Cardiovascular Risk FactorBrazil