Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases

NCT07495891 | Not Yet Recruiting

• 1 other identifier: 2025-A02386-43
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the extent to which different approaches to adapted physical activity coaching influence physical fitness, psycho-behavioral, and anthropometric parameters in patients with stabilized chronic conditions who have been referred to a Sport-Health Center by their physician. The trial includes four parallel groups, distinguishing between two program durations (3 months or 6 months) and the use or non-use of a smartwatch as a tool for monitoring activity. All participants complete 24 sessions of adapted physical activity (APA), in accordance with the standard practices of the La Musse Sport-Health Center, where the study is entirely conducted. However, the distribution of sessions differs by group: two sessions per week over three months or one session per week over six months. Randomization is stratified by age, sex, and baseline fitness level. Assessments are conducted at the following five time points: enrollment (T0), end of the 3-month program (T1), end of the 6-month program (T2), followed by follow-up at 12 months (T3) and 18 months (T4), to observe the durability of the effects after the supervised phase. The primary outcome measure is improvement in physical fitness and anthropometric parameters, objectively measured using tests recognized for their reliability (TDM6, Sit-to-Stand 30s, Timed Up and Go, Sit and Reach, grip strength, BMI, waist circumference). The secondary outcomes focus on changes in motivation toward health-related physical activity (EMAPS), perceived self-efficacy to engage in physical activity (ECS), and self-reported physical activity (IPAQ-SF), which will be collected regularly throughout the program, more frequently than in standard care. A total of 280 patients will be enrolled to ensure sufficient statistical power, taking into account an anticipated loss-to-follow-up rate over 18 months. Data collection and processing will be pseudonymized and conducted on the secure network of La Musse Hospital.

Conditions

Adapted Physical Activity; Smartwatches; Chronic Disease; Motivation for Physical Activity; Physical Fitness

Keywords

Adapted physical activity; Chronic diseases; Smartwatch; Sustainability of effects; Motivation for physical activity; Self-efficacy in physical activity; Physical fitness; Longitudinal follow-up

Outcome Measures

Primary Outcomes (1)

• Improvements in physical fitness and anthropometric parameters

  Several tests will be conducted: The TDM6, which assesses cardiorespiratory fitness by measuring the distance (in meters) covered while walking at a brisk pace for six minutes; The 30-second "Sit to Stand" test, which measures quadriceps muscle endurance as well as physical capacity; The handgrip test, which assesses upper limb muscle strength; The "Sit and Reach" test, which assesses lower limb flexibility and the range of motion of the posterior chain; The "Timed Up and Go" test, which assesses overall functional mobility through a sequence of movements (standing up from a chair, walking three meters, turning around, returning, and sitting down); Body Mass Index (BMI) will be calculated using body weight (in kilograms) divided by height squared (in meters); Body weight will be measured using a calibrated electronic scale, with the participant fully clothed and barefoot; Waist circumference will be measured using a non-stretchable anthropometric tape measuring tape, placed midway bet

  At the start of the program, 3 months after the first assessment, and then 6 months, 12 months, and 18 months

Secondary Outcomes (4)

• The Health-Related Physical Activity Motivation Scale

  At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment

• The Exercise Confidence Survey (ECS)

  At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.

• The International Physical Activity Questionnaire

  At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.

• The meCUE

  At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.

Study Arms (4)

Group A: APA for 3 months, without a smartwatch

EXPERIMENTAL

APA for 3 months, without a smartwatch

Other: Health and Fitness Program

Group B: APA for 3 months, with a smartwatch

EXPERIMENTAL

APA for 3 months, with a smartwatch

Other: Health and Fitness Program

Group C: APA for 6 months, without a smartwatch

EXPERIMENTAL

APA for 6 months, without a smartwatch

Other: Health and Fitness Program

Group D: APA for 6 months, with a smartwatch

EXPERIMENTAL

APA for 6 months, with a smartwatch

Other: Health and Fitness Program

Interventions

Health and Fitness Program OTHER

Common Practices at MSS In the standard setting of MSS La Musse, participants are referred by their primary care physician, a specialist involved in prescribing physical activity programs. Each participant undergoes an individual pre-test guided by the protocols of the National Observatory of Physical and Sports Activities (ONAPS), which assesses various parameters of physical fitness as well as certain psychological aspects (see Appendix - ONAPS protocol). These assessments serve as the basis for referral to a personalized physical activity plan (PPAP), developed jointly with a physical activity instructor. These assessments serve as the basis for referral to a personalized physical activity plan (PPAP), developed jointly with a physical activity instructor. This PPAP defines weekly goals centered on independent physical activity (gentle mobility, self-directed exercises at home), combating a sedentary lifestyle (reducing time spent resting), and participation in supervised sessions (

Group A: APA for 3 months, without a smartwatch; Group B: APA for 3 months, with a smartwatch; Group C: APA for 6 months, without a smartwatch; Group D: APA for 6 months, with a smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• French-speaking patients
• Patients with a chronic condition diagnosed by a doctor
• Patients with a doctor's prescription for APA
• Patients capable of understanding instructions
• Patients enrolled in the Social Security system
• Patients referred to Maison Sport Santé La Musse by a doctor for the first time
• Medical contraindications to physical exertion
• Pregnant women
• Individuals under legal guardianship, conservatorship, or judicial protection.
• Severe cognitive or motor impairment
• Lack of proficiency in French
• Patients in the acute phase requiring specialized care
• Patients simultaneously participating in another interventional research study
• Inability to attend sessions regularly or adhere to the schedule of evaluations.

You may not qualify if:

• Completion of fewer than 16 APA sessions (less than 70% of sessions)
• Acute exacerbation of a chronic condition during follow-up
• Completion of a patient therapeutic education program

Sponsors & Collaborators

• Hopital La Musse: lead

MeSH Terms

Conditions

Chronic Disease

Interventions

Health

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Central Study Contacts

Héloïse BAILLET, Dr

CONTACT

+33(0)232293047; h.baillet@hlrs-lamusse.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03