Adapted Physical ActivityDURATECH-APANCT07495891
Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases
A study testing Health and Fitness Program in people with Adapted Physical Activity and Smartwatches, run by Hopital La Musse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adapted Physical Activity, Smartwatches, Chronic Disease
- What is being tested?
- Health and Fitness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital La Musse
Saint-Sébastien-de-Morsent
Héloïse BAILLET, 0232293047, h.baillet@hlrs-lamusse.net
About this study
Official title: 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.
- Conditions
- Adapted Physical Activity, Smartwatches, Chronic Disease, Motivation for Physical Activity, Physical Fitness
- Being tested
- Health and Fitness Program
- Keywords
- Adapted physical activity, Chronic diseases, Smartwatch, Sustainability of effects, Motivation for physical activity, Self-efficacy in physical activity, Physical fitness, Longitudinal follow-up
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Fitness ProgramOther
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 (
| Study group | Role | What they receive |
|---|---|---|
| Group A: APA for 3 months, without a smartwatch | Experimental | APA for 3 months, without a smartwatch Receives: Other: Health and Fitness Program |
| Group B: APA for 3 months, with a smartwatch | Experimental | APA for 3 months, with a smartwatch Receives: Other: Health and Fitness Program |
| Group C: APA for 6 months, without a smartwatch | Experimental | APA for 6 months, without a smartwatch Receives: Other: Health and Fitness Program |
| Group D: APA for 6 months, with a smartwatch | Experimental | APA for 6 months, with a smartwatch Receives: Other: Health and Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: 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."
Measured: 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.
Measured: 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).
Measured: At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Mar 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adapted Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495891
- Sponsor's protocol ID
- 2025-A02386-43
- Acronym
- DURATECH-APA
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07495891
- Acronym / sponsor ID
- DURATECH-APA / 2025-A02386-43
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: APA for 3 months, without a smartwatch | Experimental | Other: Health and Fitness ProgramAPA for 3 months, without a smartwatch |
| Group B: APA for 3 months, with a smartwatch | Experimental | Other: Health and Fitness ProgramAPA for 3 months, with a smartwatch |
| Group C: APA for 6 months, without a smartwatch | Experimental | Other: Health and Fitness ProgramAPA for 6 months, without a smartwatch |
| Group D: APA for 6 months, with a smartwatch | Experimental | Other: Health and Fitness ProgramAPA for 6 months, with a smartwatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health and Fitness ProgramCommon 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 ( | Other | 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 |
Primary outcome
Improvements in physical fitness and anthropometric parameters
Time frame: At the start of the program, 3 months after the first assessment, and then 6 months, 12 months, and 18 months
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
4 secondary outcomes
The Health-Related Physical Activity Motivation Scale
Time frame: 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)
Time frame: 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
Time frame: At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.
The meCUE
Time frame: At the start of the program, and then 3 months, 6 months, 12 months, and 18 months after the first assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and Fitness Program in people with Adapted Physical Activity and Smartwatches, run by Hopital La Musse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Héloïse BAILLET, Dr (+33(0)232293047, h.baillet@hlrs-lamusse.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in physical fitness and anthropometric parameters (time frame: At the start of the program, 3 months after the first assessment, and then 6 months, 12 months, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.