Status:
TERMINATED
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03305926
Start Date
May 14 2018
End Date
April 20 2022
Last Update
December 1 2022
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000