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NCT05207072: REHAB+

Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients

Status unknown Last updated 26 January 2022
What this trial tests

trial in Cardiac Rehabilitation in 900 participants. Status unknown.

Timeline
6 December 2021
Primary endpoint
1 September 2023
1 December 2023

Quick facts

Lead sponsorMaastricht University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment900
Start date6 December 2021
Primary completion1 September 2023
Estimated completion1 December 2023
Sites4 locations across Netherlands, Spain

Conditions studied

Sponsor

Maastricht University

Who can join

18 and older, any sex, with Cardiac Rehabilitation or Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiac rehabilitation (CR) programmes are effective measures to reduce recurrent ischemic events in post-acute coronary syndrome (ACS) patients. However, participation rates in CR programmes following myocardial infarction remain low and their long-term effects are uncertain. Home-based CR in combination with novel innovative e-Health applications could overcome barriers to accessibility and participation. Rehab+, a mobile cardiac rehabilitation (mCR) programme co-created with patients and rehabilitation centres, is designed to future-proof CR and to make CR more accessible to patients. Moreover, Rehab+ will be offered for 12 consecutive months after myocardial infarction and could therefore result in greater sustained effects. This prospective, investigator-initiated, multicentre, matched control, observational trial intends to enroll 900 post-ACS patients. Subjects following ACS will be enrolled in the hospital if they meet all the eligibility criteria. Each subject will be able to choose between one of the 2 treatment groups, i.e. 12 months of mCR or 6-8 weeks of traditional centre-based CR. The follow-up for each subject will take 12 months for both groups. The primary objective of this study is to assess whether mCR programme result in better sustained effects on physical, mental and social outcomes in post-ACS patients, as compared to post-ACS patients who follow the traditional CR programme. The main hypothesis is that mCR is expected to result in greater improvement in Quality of Life at 12 months as compared to traditional CR.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Cardiac Rehabilitation

Currently open trials in the same condition.

Other Maastricht University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05207072.

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