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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional CVR programme
Connected CVR programme
Follow-up visit M2
Follow-up vsit M8
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Chu Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional CVR

eCVR

Arm Description

Outcomes

Primary Outcome Measures

peak VO2, measured during an effort test

Secondary Outcome Measures

Full Information

First Posted
October 4, 2017
Last Updated
November 29, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03305926
Brief Title
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?
Acronym
eRCV
Official Title
Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Early termination due to changes in care management following the COVID context (remote/connected rehabilitation)
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional CVR
Arm Type
Active Comparator
Arm Title
eCVR
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Conventional CVR programme
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Connected CVR programme
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Follow-up visit M2
Intervention Description
Effort test and evaluation at the end of the CVR programme
Intervention Type
Other
Intervention Name(s)
Follow-up vsit M8
Intervention Description
Evaluation at 8 months following the CVR programme
Primary Outcome Measure Information:
Title
peak VO2, measured during an effort test
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

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Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation?

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