Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? (eRCV)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Conventional CVR programme; Other: Follow-up visit M2; Other: Follow-up vsit M8; Other: Connected CVR programme

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional CVR	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: 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
Experimental: eCVR	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peak VO2, measured during an effort test	Month 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CASILLAS FRM 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No