Trials / Terminated
TerminatedNCT03305926
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical capacity, accelerating return to activities and reinsertion and reducing mortality. It associates reconditioning to effort and therapeutic education for the optimal control of " risk factors ". It corresponds to a global approach to patients, thus counterbalancing the tendency to hyperspecialise in medicine. However, because of the lack of specialised centres, only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in e-health, the deployment of the Internet and certain " connected " devices may provide alternatives outside hospital, by enabling the follow-up of patients and their physiological parameters (heart rate, blood pressure, weigh, physical activity…), and the adaptation - using an interactive web platform - of the physical activity programme, nutrition, compliance with medication and weaning from smoking. This project proposes to evaluate the effects of a so-called " connected " CVR programme, and to show its non-inferiority compared with a conventional CVR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Conventional CVR programme | Programme in a CVR centre involving 20 sessions of reconditioning to effort, 3 times per week for roughly 7 weeks, as well as 14 sessions of therapeutic education in groups. |
| OTHER | Connected CVR programme | First week in the CVR centre with 3 sessions combining reconditioning to effort, individual interviews and targeted therapeutic education, so as to define the objectives and methods of the connected CVR at home for the 6 following weeks. |
| OTHER | Follow-up visit M2 | Effort test and evaluation at the end of the CVR programme |
| OTHER | Follow-up vsit M8 | Evaluation at 8 months following the CVR programme |
Timeline
- Start date
- 2018-05-14
- Primary completion
- 2022-04-20
- Completion
- 2022-04-20
- First posted
- 2017-10-10
- Last updated
- 2022-12-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03305926. Inclusion in this directory is not an endorsement.