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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Other: Follow-up visit M2
Other: Conventional CVR programme
Other: Connected CVR programme
Other: Follow-up vsit M8

Study type

Interventional

Funder types

Other

Identifiers

NCT03305926
CASILLAS FRM 2016

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Conventional CVR
Active Comparator group
Treatment:
Other: Follow-up visit M2
Other: Follow-up vsit M8
Other: Conventional CVR programme
eCVR
Experimental group
Treatment:
Other: Connected CVR programme
Other: Follow-up visit M2
Other: Follow-up vsit M8

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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