Status:
UNKNOWN
Effect of Implant-based Telerehabilitation
Lead Sponsor:
Hasselt University
Conditions:
Heart Failure
Telemedicine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients with an implanted CRT device in Jessa Hospital Hasselt in Belgium.
Detailed Description
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients with an implanted CRT device in Jessa Hospital Hasselt in Belgium. Subjects that do not violate any of the exc...
Eligibility Criteria
Inclusion
- \- Patients with an implanted CRT-D or CRT-P device in which monitoring of physical activity is possible
- CRT device must be implanted for at least three months
- Dutch speaking and understanding
- Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
- Age ≥ 18 years
- CRT capable of transmitting data about physical activity in an interpretable manner
- Willingness and physically able to follow an email-based or SMS-based telemonitoring program and other study procedures in a 12 weeks follow-up period.
- Clinically stable without inducible ischemia or high-risk ventricular arrhythmia, confirmed by the last available maximal ergo-spirometry test
- Possession of smartphone or email address, which the patients regularly check, in order to receive feedback from the research staff
Exclusion
- The presence of an absolute or relative contraindication to moderate- intensity exercise
- Participation in a cardiac revalidation program in the months before enrollment in the study
- Patients with planned interventional procedure or surgery in next three months
- Present cardiovascular complaints that might interfere with exertion: unstable angina, recent ICD shock etc.
- Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
- Orthopedic, neurologic, or any other pathologic condition that makes the patient physically unable to follow an email-based or SMS-based telemonitoring program
- Any condition, which, in the opinion of the investigator, would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigator's judgment
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04376983
Start Date
March 1 2020
End Date
April 30 2023
Last Update
March 15 2022
Active Locations (1)
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1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500