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

Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases: the Influence of Program Duration and the Use of a Smartwatch

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Disease; Physical Fitness; Adapted Physical Activity; Motivation for Physical Activity; Smartwatches
• Intervention / Treatment: Other: Health and Fitness Program

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Héloïse BAILLET, Dr; Phone Number: +33(0)232293047; Email: h.baillet@hlrs-lamusse.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Non inclusion Criteria :

• 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.
• Patients who have already completed a program at the Maison Sport Santé

Exclusion Criteria:

• Completion of fewer than 16 APA sessions (less than 70% of sessions)
• Acute exacerbation of a chronic condition during follow-up
• For groups without smartwatches, the use of a digital tool such as a physical activity tracker by participants would constitute an exclusion criterion
• Completion of a patient therapeutic education program

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: APA for 3 months, without a smartwatch; APA for 3 months, without a smartwatch	Other: Health and Fitness Program; 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 (
Experimental: Group B: APA for 3 months, with a smartwatch; APA for 3 months, with a smartwatch	Other: Health and Fitness Program; 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 (
Experimental: Group C: APA for 6 months, without a smartwatch; APA for 6 months, without a smartwatch	Other: Health and Fitness Program; 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 (
Experimental: Group D: APA for 6 months, with a smartwatch; APA for 6 months, with a smartwatch	Other: Health and Fitness Program; 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 (

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Health-Related Physical Activity Motivation Scale	The Health-Related Physical Activity Motivation Scale (EMAPS) measures the various forms of motivation described by self-determination theory. It consists of 18 items rated on a seven-point scale and includes six dimensions (intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation).	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)	The Exercise Confidence Survey (ECS) is a questionnaire designed to measure perceived self-efficacy in the regular practice of physical activity. It consists of 12 items organized into two dimensions: adherence to PA, which assesses confidence in maintaining physical activity despite various obstacles (fatigue, stress, lack of support, obligations), and time management, which focuses on the ability to organize one's schedule to incorporate PA. Responses are rated on a five-point scale ranging from "I know I can't" to "I know I can."	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	The International Physical Activity Questionnaire - Short Form (IPAQ-SF, 7-day) is used to assess self-reported physical activity over the previous week. It includes questions on the frequency and duration of vigorous and moderate-intensity activities, walking, as well as time spent sitting. Responses are converted into MET-minutes per week, allowing individuals to be classified into three levels of physical activity: low, moderate, or high. An official French version is available and widely used, although psychometric validation of the short form remains limited.	At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.
The meCUE	The meCUE (Modular Evaluation of Key Components of the User Experience) scale is a standardized questionnaire used to evaluate the key components of the user experience, whether instrumental (utility, usability) or non-instrumental (aesthetics, status, engagement).	At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.

Collaborators and Investigators

• Sponsor: Hopital La Musse

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physical fitness; Smartwatch; Chronic diseases; Adapted physical activity; Longitudinal follow-up; Motivation for physical activity; Sustainability of effects; Self-efficacy in physical activity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Population Characteristics; Health
• Other Study ID Numbers: 2025-A02386-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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