NCT03305926

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2018

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

December 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

October 4, 2017

Last Update Submit

November 29, 2022

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • peak VO2, measured during an effort test

    Month 2

Study Arms (2)

Conventional CVR

ACTIVE COMPARATOR
Other: Conventional CVR programmeOther: Follow-up visit M2Other: Follow-up vsit M8

eCVR

EXPERIMENTAL
Other: Connected CVR programmeOther: Follow-up visit M2Other: Follow-up vsit M8

Interventions

Conventional CVR programmeOTHER

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.

Conventional CVR
Connected CVR programmeOTHER

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.

eCVR
Follow-up visit M2OTHER

Effort test and evaluation at the end of the CVR programme

Conventional CVReCVR
Follow-up vsit M8OTHER

Evaluation at 8 months following the CVR programme

Conventional CVReCVR

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 10, 2017

Study Start

May 14, 2018

Primary Completion

April 20, 2022

Study Completion

April 20, 2022

Last Updated

December 1, 2022

Record last verified: 2022-05

Locations

FR(1)