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

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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]

Secondary outcome measures (4)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07495891 · 2025-A02386-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗