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NCT Number: NCT07495891

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

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.

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Key information

Conditions

Adapted Physical Activity Chronic Disease Disease Attributes Motivation for Physical Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Fitness Smartwatches

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 (

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 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).

  2. 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 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."

  3. 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 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.

  4. 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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Héloïse BAILLET, Dr

CONTACT

[email protected]

+33(0)232293047

Sponsors and collaborators

Lead sponsor

Hopital La Musse

Other

Registry information

Official study 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

Acronym: DURATECH-APA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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