Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation (APA&CO2)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Acute Coronary Syndrome; Cardiac Rehabilitation
• Intervention / Treatment: Other: Connected application

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DRCI CHU Angers; Phone Number: +33241356329; Email: drci-promotion-interne@chu-angers.fr
• Study Contact Backup: Name: Marie Gaume; Phone Number: +33241496000; Email: unite-recherche-clinique@ch-cholet.fr

Study Locations

• France
  • Cholet, France, 49300
    • Recruiting
    • CH Cholet
    • Contact: YOUNA GOURRONC, DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Classic care; Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation.
Experimental: Connected application; Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.	Other: Connected application; Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
to describe the use of the application in the intervention group	number of recorded sessions	at 6 months
to describe patient satisfaction in the intervention group	scale 0-10 (min 0 - max 10)	at 6 months
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
to describe the interactions with other users in the intervention group	scale 0-4 (min 0 -max 4)	at 6 months
to describe participation in challenges in the intervention group	scale 0-3 (min 0 - max 3)	at 6 months
to describe the continued use of the application in the intervention group	number of recorded sessions	at 12 months
to describe the continued use of the application in the intervention group	number of recorded sessions	at 18 months

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Paul Da Ros Vettoretto, Centre Hospitalier de Cholet

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): January 11, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Acute Coronary Syndrome; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Acute Coronary Syndrome
• Other Study ID Numbers: 2022-A01974-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No