Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?
NCT ID: NCT03305926
Last Updated: 2022-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2018-05-14
2022-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional CVR
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.
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
eCVR
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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CASILLAS FRM 2016
Identifier Type: -
Identifier Source: org_study_id
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