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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646849
Other study ID # 2022-A01974-39
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 12, 2023
Est. completion date July 1, 2026

Study information

Verified date March 2024
Source University Hospital, Angers
Contact Marie Gaume
Phone +33241496000
Email unite-recherche-clinique@ch-cholet.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.


Recruitment information / eligibility

Status Recruiting
Enrollment 208
Est. completion date July 1, 2026
Est. primary completion date January 11, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patient reluctant or unable to comply with the protocol - Pregnant, parturient and nursing mothers - Persons deprived of their liberty or under guardianship

Study Design


Intervention

Other:
Connected application
Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.

Locations

Country Name City State
France Ch Cholet Cholet

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation. questionnaires IPAQ at 6 months
Secondary to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation. questionnaire EMAPS at 6 months
Secondary to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups questionnaires IPAQ at 6 months
Secondary to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups questionnaire EMAPS at 6 months
Secondary 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). accelerometer at 6 months
Secondary to describe the use of the application in the intervention group number of recorded sessions at 6 months
Secondary to describe patient satisfaction in the intervention group scale 0-10 (min 0 - max 10) at 6 months
Secondary to describe the frequency of use of patients in the intervention group to be recorded their sessions scale 0-4 (min 0 - max 4) at 6 months
Secondary to describe the interactions with other users in the intervention group scale 0-4 (min 0 -max 4) at 6 months
Secondary to describe participation in challenges in the intervention group scale 0-3 (min 0 - max 3) at 6 months
Secondary to describe the continued use of the application in the intervention group number of recorded sessions at 12 months
Secondary to describe the continued use of the application in the intervention group number of recorded sessions at 18 months
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