Clinical Trials Directory

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

TypeNameDescription
OTHERConventional CVR programmeProgramme 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.
OTHERConnected CVR programmeFirst 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.
OTHERFollow-up visit M2Effort test and evaluation at the end of the CVR programme
OTHERFollow-up vsit M8Evaluation 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.