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Telerehabilitation in Coronary Heart Disease (TRiCH)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Center-based cardiac rehabilitation
Home-based training with telemonitoring guidance
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Center-based cardiac rehabilitation

Home-based training with telemonitoring guidance

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

exercise tolerance
comparison of evolution of exercise tolerance from baseline to one-year
exercise tolerance
comparison of evolution of exercise tolerance from baseline to 12 weeks

Secondary Outcome Measures

Full Information

First Posted
January 27, 2014
Last Updated
June 20, 2019
Sponsor
KU Leuven
Collaborators
Jessa Hospital, Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT02047942
Brief Title
Telerehabilitation in Coronary Heart Disease
Acronym
TRiCH
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Jessa Hospital, Hasselt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Center-based cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Home-based training with telemonitoring guidance
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Center-based cardiac rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Home-based training with telemonitoring guidance
Primary Outcome Measure Information:
Title
exercise tolerance
Description
comparison of evolution of exercise tolerance from baseline to one-year
Time Frame
1 year
Title
exercise tolerance
Description
comparison of evolution of exercise tolerance from baseline to 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3001
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
31787026
Citation
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.
Results Reference
derived
PubMed Identifier
29934286
Citation
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.
Results Reference
derived

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Telerehabilitation in Coronary Heart Disease

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