Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?

Coronary Artery Disease Clinical Trial

— eRCV  

Official title:

Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03305926
• Other study ID #: CASILLAS FRM 2016
• Status: Terminated
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: April 20, 2022

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• men or women,

• aged between 30 and 75 years,

• presenting coronary artery disease without heart failure (Left ventricular ejection fraction on echocardiography (Simpson method) > 45 %).

• Patients who have provided written consent.

Exclusion Criteria:

• Adults under guardianship

• Patients without national health insurance cover

• Pregnant or breastfeeding women

• Inability to use connected numeric devices even simple operations (tablette, cardiofrequency meter, BP monitor…)

• Heart failure, with a low or preserved left ventricular ejection fraction

• Contra-indication for cardiovascular rehabilitation :

• Severe obstructive heart disease (severe and asymptomatic obstacle to left ventricular ejection)

• Acute unstable coronary syndrome

• Tight aortic valve stenosis

• Severe progressive cardiac rhythm or conduction disorders without pacing and discovered during the initial stress test

• Intracavitary thrombus

• Presence of moderate to severe pericardial effusion

• Severe pulmonary artery hypertension (systolic PAP >70mmHg)

• Recent history of venous thromboembolism (previous 3 months)

• Progressive inflammatory or infectious disease

• Inability to engage in physical exercise

• Impaired executive functions making it impossible to understand and comply with the CVR programme (Mini Mental Test < 24)

• Heart transplant

• Associated medical condition likely to impair functional capacities (examples:

non-stabilised metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilised disorder such as neoplasm, systemic diseases…)

• Physical disability in the lower limbs that could hamper reconditioning, whether neurological (central or peripheral), arterial (in particular, peripheral artery disease with a systolic index < 0.6) or orthopaedic (degenerative or inflammatory rheumatism)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.
• Follow-up visit M2
Effort test and evaluation at the end of the CVR programme
• Follow-up vsit M8
Evaluation at 8 months following the CVR programme

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak VO2, measured during an effort test		Month 2