Clinical trial NCT03305926: Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?
Official title: Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: peak VO2, measured during an effort test
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: