Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs

Chronic Disease Clinical Trial

Official title: Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs

Status Not yet recruiting

Clinical Trial Summary

Although physical activity remains an essential pillar of chronicle diseases treatment, long-term adherence to physical activity (PA) continues to prove problematic. A 2019 meta-analysis as well as an overview on the treatment of chronic diseases through physical activity recommend the development of strategies for long-term adherence. Several research paths should be considered in this context.

Through the observation and the comparison of two different programs, the aim of this study is to explore what determining factors will predispose patients to include physical activity in their lifestyle and make a long-term commitment to it/to exercising.

Clinical Trial Description

Research design This is a multi-center, longitudinal, minimal risk, category 2 observational comparative study with a convergent parallel mixed method design (Creswell 2015).

The work and intervention arrangements of the two gateway programs are not altered by the research protocol, so the follow-up is strictly observational. As such, it should not affect the usual framework of care and follow-up of patients followed for a long-term condition.

It is a comparative study because it is based on the observation of 2 structures whose methods of care by the PA differ for the same objective.

The patients were followed up during the 3 months of the resumption program and then for 9 months following this program, i.e. 12 consecutive months, which makes it a longitudinal study.

The design is said to be a parallel mixed method study because in the first phase, quantitative data (attendance, quality of life, motivation via questionnaires) and qualitative data (interviews on the reasons for continuing or abandoning PA practice) are collected and analyzed at the same time and analyzed separately. QUANT+QUAL In the second phase, these data are combined in order to integrate the results from the quantitative and qualitative methods, which should allow for a cross-interpretation of the results. Using the convergent parallel mixed method, the qualitative data will complement the quantitative data in order to analyze PA behavior in relation to the interviews on factors that modified PA practice.

Process Data will be collected at T0 inclusion (at enrollment in the resumption program), at 3 months (end of the resumption program), at 6 and 12 months after inclusion.

Inclusion in the study (T0) will be performed by the physical activity educators at the time of enrollment in the corresponding resumption program. The study will be presented to patients meeting the inclusion criteria. And the physical activity educator will inform the patient and collect orally the patient's non-opposition to participate, as well as the non-opposition to the use of the patient's data. If the patient agrees, the physical activity educator will proceed to collect the following data: socio-demographic data, IPAQ, SF-12. The patient will then be informed of a forthcoming physical or telephone appointment for a semi-structured interview with the principal investigator on the reasons for entering the program. The patient will be given a letter of information about the progress of the study with the contact information of the principal investigator.

At the end of enrolment (T0), a copy of the inclusion form, the identification form and the data collected will be sent by email to the principal investigator who will anonymise them.

During 3 months, until T1, the program investigator collects the attendance data of each patient.

At T1, i.e. T0 + 3 months, the corresponding resumption program investigator transmits the attendance data as well as the data from the IPAQ, SF-12 and IMI tests collected during the orientation interview at the end of the program. Patients are informed of a future physical or telephone interview about intra-program factors that have changed PA behavior. Patients are also informed again about the further course of the study (interviews at 6 months and 1 year). In case of absence or temporary impossibility to complete all the tests with the physical activity educator, they can be carried out during a telephone interview.

At T2, i.e. T0 + 6 months, the principal investigator will meet the participants physically or by telephone 6 months (+/- 3 weeks) after their entry into the program. During this interview, the IPAQ, SF-12, and IMI tests were administered, as well as a semi-structured interview on the factors that allowed participants to maintain their PA and their PA practice over the past 3 months.

At T3, i.e., T0 + 12 months, the principal investigator conducted a physical or telephone interview with the participants 12 months (+/- 3 weeks) after they entered the program. During this interview, the IPAQ, SF-12 and IMI tests were administered, as well as a semi-structured interview on the factors allowing the maintenance of PA and the PA practice of the last 6 months. ;

Related Conditions & MeSH terms

• Chronic Disease

• NCT number: NCT04954209
• Study type: Observational
• Source: Comité Départemental Olympique et Sportif de Seine Saint Denis
• Contact: Olivier Riquier, PhD std
• Phone: +33617333194
• Email: olivier.riquier@cdos93.org
• Status: Not yet recruiting
• Start date: September 2021
• Completion date: October 2024