NCT05646849

Brief Summary

Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity. 1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity. It is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity. That is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jan 2023Jul 2026

First Submitted

Initial submission to the registry

November 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

November 21, 2022

Last Update Submit

March 25, 2024

Conditions

Cardiac RehabilitationAcute Coronary SyndromeHeart Failure

Keywords

Cardiac RehabilitationAcute Coronary SyndromeHeart Failure

Outcome Measures

Primary Outcomes (1)

  • To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity

    accelerometer

    at 6 months

Secondary Outcomes (12)

  • to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation.

    at 6 months

  • to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation.

    at 6 months

  • to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups

    at 6 months

  • to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups

    at 6 months

  • to describe the maintenance of the physical activity of the two groups according to the seasonality following the end of the cardiac rehabilitation (winter, spring, summer, autumn).

    at 6 months

  • +7 more secondary outcomes

Study Arms (2)

Classic care

NO INTERVENTION

Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation.

Connected application

EXPERIMENTAL

Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.

Other: Connected application

Interventions

Connected applicationOTHER

Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.

Connected application

Eligibility Criteria

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

You may qualify if:

  • Patient participating in cardiac rehabilitation
  • Patient with a smartphone compatible with the application
  • Patient with internet connection
  • Patient having signed the written consent to participate

You may not qualify if:

  • Patient reluctant or unable to comply with the protocol
  • Pregnant, parturient and nursing mothers
  • Persons deprived of their liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Cholet

Cholet, 49300, France

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Paul Da Ros Vettoretto

    Centre Hospitalier de Cholet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Gaume

CONTACT

+33241496000unite-recherche-clinique@ch-cholet.fr

DRCI CHU Angers

CONTACT

+33241356329drci-promotion-interne@chu-angers.fr

Study Design

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

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 12, 2022

Study Start

January 12, 2023

Primary Completion

January 11, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)