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Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?

NCT03305926 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-12-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2022-04-20
Completion
2022-04-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305926 on ClinicalTrials.gov