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NCT05207072: REHAB+
Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients
trial in Cardiac Rehabilitation in 900 participants. Status unknown.
1 September 2023
Quick facts
| Lead sponsor | Maastricht University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 900 |
| Start date | 6 December 2021 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 4 locations across Netherlands, Spain |
Conditions studied
- Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
- Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
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.
Verify or expand the search:
- PubMed search for NCT05207072
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05207072 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University
- Last refreshed: 26 January 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing