NCT05702216

Brief Summary

Cardiac tele-rehabilitation in a hybrid form can be a choise for the management of cardiovascular diseases. The aim is to increase the participation rate of patients in cardiac rehabilitation. This new form of care can be as effective as traditional care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

January 18, 2023

Last Update Submit

December 26, 2023

Conditions

Cardiac Tele-rehabilitation

Keywords

Cardiac tele-rehabilitation, cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test

    Distance covered in the 6-minute walk test

    6 weeks before baseline

Secondary Outcomes (2)

  • Stress test

    6 weeks before baseline

  • Wall Squat Test

    6 weeks before baseline

Study Arms (2)

Cardiac rehabilitation

OTHER
Other: Rehabilitation

Cardiac Tele-rehabilitation

OTHER

Tele cardiac rehabilitation in hybrid form

Other: Rehabilitation

Interventions

RehabilitationOTHER

Hybrid approach in cardiac telerehabilitation. Patients underwent 20 cardiac rehabilitation sessions: alternatively, patients underwent 10 classical cardiac rehabilitation sessions in the clinic and 10 cardiac telerehabilitation sessions at home.

Cardiac Tele-rehabilitationCardiac rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 ans
  • Patients with heart disease

You may not qualify if:

  • Cardiac decompensation
  • No stabilised acute coronary syndrome
  • Decompensated heart failure
  • Severe ventricular rhythm disorders
  • Severe functional limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique la Mitterie

Lille, 59160, France

Location

Related Publications (1)

  • Racodon M, Peze T, Masson P. Analysis of physical exercise in cardiac patients following cardiovascular rehabilitation. Acta Cardiol. 2020 Nov;75(7):598-603. doi: 10.1080/00015385.2019.1639269. Epub 2019 Jul 17.

    PMID: 31314680BACKGROUND

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Michaël RACODON, Ph.D

    CLINIQUE LA MITTERIE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research coordinator

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

October 29, 2021

Primary Completion

September 5, 2022

Study Completion

March 31, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)