Physical Literacy-Based Intervention for Chronic Disease Management

NCT ID: NCT06325306

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-10-30

Brief Summary

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The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:

* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?
* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?

Participants will:

* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.
* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.

Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes.

Detailed Description

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The study employs a quasi-experimental design to investigate the impact of physical literacy-based interventions in chronic disease management. Participants are recruited from the Citoyen en mouvement pour ma santé program, designed for adults with chronic diseases in Belgium, facilitating their engagement in adapted physical activity (APA) group sessions. The study structure includes a control group (no intervention), a traditional APA group, and an APA with Physical Literacy (APA+PL) group, each consisting of approximately 65 participants to account for potential dropouts and ensure robust statistical analysis.

The intervention lasts six months, with initial and follow-up assessments at three and six months. These evaluations measure physical literacy dimensions-motivation, confidence, physical competence, knowledge, and engagement-using a combination of questionnaires and physical tests. The assessment tool, inspired by Whitehead's definitions and the IPLA framework, encompasses six core dimensions of physical literacy. It integrates closed-ended questions for quantitative analysis and open-ended questions for qualitative insights, offering a comprehensive view of participants physical literacy journey.

The APA+PL intervention is meticulously planned, following the Physical Literacy Interventions Reporting Template (PLIRT), focusing on enhancing physical literacy through tailored physical activity sessions. These sessions, led by qualified APA educators, are structured to integrate physical literacy elements seamlessly into the exercise routines. The program includes varied physical activities aiming to improve physical fitness (endurance, strength, flexibility, balance) and instill a deeper understanding and appreciation of physical literacy in participants.

The study data analysis plan involves a mixed-methods approach, capturing both the quantitative changes in physical literacy scores and the qualitative experiences of participants. Quantitative data will be analyzed using mixed ANOVA models to evaluate within-subject changes and between-group differences in physical literacy scores. Qualitative data, derived from open-ended questionnaire responses, will undergo thematic analysis to identify recurring themes and insights into the participants experiences and perceptions of the intervention.

Researchers will perform subgroup analyses based on age, gender, and chronic disease type, with adjusted analyses for potential confounders. The study seeks to understand the broader implications of physical literacy interventions in chronic disease management, aiming to inform future public health strategies and promote sustained engagement in physical activities among chronic disease patients.

This comprehensive approach to evaluating physical literacy interventions will contribute significantly to the understanding of how these interventions can be optimized to support chronic disease management in adult populations, potentially guiding future healthcare practices and policies.

Conditions

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Chronic Disease Chronic Disease Management Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Participants in this arm receive no specific intervention. They are on a waiting list for the 'Citoyen en mouvement pour ma santé' program, allowing for natural observation of their health progression without targeted physical literacy interventions. This group serves as a baseline to compare the effects of the adapted physical activity (APA) programs with and without physical literacy components.

Group Type NO_INTERVENTION

No interventions assigned to this group

Traditional APA Group

This group engages in a standard adapted physical activity program, focusing on improving physical fitness and mobility. The intervention is designed for chronic disease management, emphasizing regular physical exercises without an explicit incorporation of physical literacy principles. The same APA educator supervises all sessions to maintain consistency in the delivery of physical activity interventions.

Group Type EXPERIMENTAL

Traditional APA

Intervention Type BEHAVIORAL

12 sessions of 1,5 hour are organized (once per week). The first session is primarily focused on the PL assessment, followed by a comprehensive introduction to physical conditioning exercises. Each of the subsequent sessions (n=10), participants will receive an intervention focused on the development of their physical fitness (endurance, strength, flexibility, balance). Each session will commence with a 15 minute warm-up comprising of a blend of cardiovascular and joint mobilization exercises. The core part of each session will be dedicated to session-specific exercises targeting key physical competencies such as endurance, strength, flexibility, and balance, along with other motor skills. . The size of the group will never exceed a number of 15 participants. At the conclusion of each session, participants will be guided through a return-to-calm sequence that included stretching and relaxation exercises.

APA+PL Group

Participants in this arm participate in an adapted physical activity program enriched with physical literacy elements. The intervention aims to enhance physical activity engagement through increased motivation, confidence, knowledge, and understanding. This arm explores the added benefits of integrating physical literacy into traditional APA programs for chronic disease patients.

Group Type EXPERIMENTAL

APA+PL

Intervention Type BEHAVIORAL

The general content and duration of this intervention is the same as in the traditional APA intervention, but with an extra particular and explicit emphasis on PL dimensions (6) during the sessions. While the dimension of physical competence is consistently incorporated into the sessions, the remaining 5 dimensions of PL are addressed twicely over the course of the semester with the setting of specific goals and intervention content. This could involve quizzes or games integrated into circuits or exercise workshops, role-play exercises simulating real-life situations, or social interactions between participants with a particular focus on PL-related topics. In addition to the sessions, a follow-up telephone call is scheduled between the educator and each participant during the 2 weeks following the initial PL assessment to share individual PL assessment results and assist participants in setting person-centered goals using a motivational interviewing technique.

Interventions

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Traditional APA

12 sessions of 1,5 hour are organized (once per week). The first session is primarily focused on the PL assessment, followed by a comprehensive introduction to physical conditioning exercises. Each of the subsequent sessions (n=10), participants will receive an intervention focused on the development of their physical fitness (endurance, strength, flexibility, balance). Each session will commence with a 15 minute warm-up comprising of a blend of cardiovascular and joint mobilization exercises. The core part of each session will be dedicated to session-specific exercises targeting key physical competencies such as endurance, strength, flexibility, and balance, along with other motor skills. . The size of the group will never exceed a number of 15 participants. At the conclusion of each session, participants will be guided through a return-to-calm sequence that included stretching and relaxation exercises.

Intervention Type BEHAVIORAL

APA+PL

The general content and duration of this intervention is the same as in the traditional APA intervention, but with an extra particular and explicit emphasis on PL dimensions (6) during the sessions. While the dimension of physical competence is consistently incorporated into the sessions, the remaining 5 dimensions of PL are addressed twicely over the course of the semester with the setting of specific goals and intervention content. This could involve quizzes or games integrated into circuits or exercise workshops, role-play exercises simulating real-life situations, or social interactions between participants with a particular focus on PL-related topics. In addition to the sessions, a follow-up telephone call is scheduled between the educator and each participant during the 2 weeks following the initial PL assessment to share individual PL assessment results and assist participants in setting person-centered goals using a motivational interviewing technique.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years or older.
* Diagnosed with one or more chronic diseases.
* Possessing a medical clearance to participate in physical activities.
* Enrolled in the Citoyen en mouvement pour ma santé program.
* Willing and able to give informed consent for participation in the study.

Exclusion Criteria

* Individuals younger than 18 years.
* Without a formal diagnosis of a chronic disease.
* Lacking medical clearance for engaging in physical activity.
* Not enrolled in the Citoyen en mouvement pour ma santé program.
* Unable to provide informed consent due to cognitive impairment or other reasons.
* Those who have severe mobility limitations or other health conditions that preclude safe participation in the physical activity sessions as determined by medical assessment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Alexandre MOUTON

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Sportif du Sart-Tilman

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Alexandre Mouton, Phd

Role: CONTACT

+32 4366 38 96

Jean-Pierre Weerts, M.S.

Role: CONTACT

+3243663818

Facility Contacts

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Jean-Pierre Weerts, M.A.

Role: primary

+32 4366 3818

Cédric Lehance, M.A.

Role: backup

+32 477490055

References

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Mouton A, Weerts JP, Carl J. Physical literacy-based intervention for chronic disease management: a quasi-experimental study protocol. BMC Sports Sci Med Rehabil. 2025 May 30;17(1):136. doi: 10.1186/s13102-025-01175-6.

Reference Type DERIVED
PMID: 40448250 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.chuliege.be/jcms/c2_26224880/en-mouvement-pour-ma-sante/accueil

Website of the general project Citoyen en mouvement pour ma santé.

Other Identifiers

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B7072023000102

Identifier Type: OTHER

Identifier Source: secondary_id

2023/392

Identifier Type: -

Identifier Source: org_study_id

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