Clinical trial NCT06320496: Evaluation of the Effect of a Physical Activity Recovery Stay
Official title: Evaluation of the Effect of a Physical Activity Recovery Stay on the Physical Condition and Quality of Life of Children in a Situation of Physical Deconditioning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Children With Cerebral Palsy
Children With Cancer
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The children taking part in the return-to-physical-activity program are referred to the Flavigny-sur-Moselle CMPRE for medical consultation due to a state of deconditioning to physical exertion concomitant with a pathological situation. The pathology most frequently encountered during this stay is cerebral palsy. However, the Flavigny CMPRE is accredited in a number of fields (orthopedics, burns, neurology, oncology), and the pathologies of the children referred to this stay are representative of these. These include children with scoliosis, obesity, Guillain-Barré syndrome, cystic fibrosis, Charcot's disease and cancer.

Brief summary: A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.

To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".

In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning.


Eligibility criteria: Inclusion Criteria:

* Children with a pathology (chronic disease, rare disease or disability) in a state of deconditioning to exercise
* Taken in charge at the CMPRE for a stay to resume physical activity

Exclusion Criteria:

* Age under 8 and over 18
* Patients undergoing rehabilitation during the stay
* Patients with a significant change in their therapeutic management during the stay
* Significant cognitive impairment preventing comprehension of instructions
* Significant club or leisure sports activity (3x/week)
* Electric wheelchair
* Non-compliance with stay (5 ½ days missed out of total stay)
* Participation in another study during the return-to-physical-activity stay

Primary outcomes:
measure: Diagnoform test score
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary outcomes:
measure: KidScreen52 quality-of-life scale score.
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Impedance measurement
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Exercise test on ergometer
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Anamnesis
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: 6-minute walk test
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Energy expenditure index
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Gluteal bridge
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Shirado test
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Sorensen test
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Timed Up and Down Stairs (TUDS) test
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Floor survey test
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28.
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: The Canadian Occupational Performance Measure
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
measure: A motivational questionnaire
timeFrame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
References: