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

July 5, 2021 updated by: Comité Départemental Olympique et Sportif de Seine Saint Denis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with a chronic disease who don't practice physical activity, which is part of the treatment

Description

Inclusion Criteria:

  • Adults with a chronic disease
  • Consenting
  • medical aptitude to physical activity
  • registrated in one of the two resumption programs

Exclusion Criteria:

  • Doing less than a session of physical activity per week during the resumption program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital program of resumption
Program of resumption with physical activities in the hospital
Other: Physical activities in hospital
3 month in a resumption program of physical activity in hospital
Non hospital program of resumption
Program of resumption outside hospital with discovery sessions
Other: Physical activity outside hospital
3 month in a resumption program of physical activity outside hospital with discovery sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practice of physical activity
Time Frame: 12 month
During a year we follow the physical activity rate with the IPAQ questionary and interviews. With interviews we also question the kind of physical activity.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported perceptions of quality of life
Time Frame: 12 month

The evaluation of the quality of life will be measured at 4 points of the study via the SF-12 questionnaire.

The SF-12 is a general health assessment questionnaire derived from the SF-36: it combines synthetic information with a score on the physical dimension and a score on the mental dimension. It includes 12 items, divided into the same 8 dimensions as the SF-36 (physical activity; life and relationships with others; physical pain; perceived health; vitality; limitations due to psychological state; limitations due to physical state; psychological health. These eight dimensions are used to measure two summary scores of the quality of life of individuals: the physical composite score (PCS) and the mental composite score (MCS) (Leplège Alain, 2001).

Each quality of life score will be compared with the different phases of physical activity in order to monitor its evolution and influence on adherence to physical activity and its continuation.
12 month
Perceptions of enjoyment in practice of physical activity
Time Frame: 12 month

The enjoyment of physical activity will be measured at three points in the study, T1, T2 and T3, using the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1989). This scale determines the pleasure taken in the practice of physical activity over a given period. Using 4 statements (e.g., "I liked the activities I did"), responses are rated on a scale of 1 to 5 from "strongly disagree" to "strongly agree. A high score is synonymous with great pleasure in practicing physical activity.

Each score will be compared to the different phases of physical activity in order to follow the evolution and the influence of pleasure in the practice for its adherence and continuation.
12 month
The qualitative motivational criteria of physical activity practice
Time Frame: 12 month

The qualitative motivational criteria collected through 4 semi-structured interviews:

  • at T0: reasons for entering the program
  • at T1: intra-program factors that modified PA behavior
  • at T2: information on PA practice following the program: supervised (what type of structure), independent, activity(ies) practiced + factors allowing PA maintenance and PA practice in the last 3 months
  • at T3: information on PA practice following the program: supervised (what type of facility), independent, activity(ies) practiced + factors allowing PA maintenance and PA practice in the last 6 months
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of discovery sessions
Time Frame: 12 month
With interviews we'd like to know the influence of discovery sessions on the long-term commitment in practice of physical activity
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comité Départemental Olympique et Sportif de Seine Saint Denis

Investigators

  • Principal Investigator: Olivier Riquier, PhD std, Comité Départemental Olympique et Sportif de Seine Saint Denis / Université de Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERSISTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All individual informations will be anonymous

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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