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Clinical Trials/NCT06320496
NCT06320496
Recruiting
Not Applicable

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

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est1 site in 1 country50 target enrollmentMarch 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Enrollment
50
Locations
1
Primary Endpoint
Diagnoform test score
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2022
End Date
December 2025
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Diagnoform test score

Time Frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient

To evaluate the effect of the return to physical activity stay prescribed by the doctors at the Flavigny CMPRE on the physical condition of the children taking part in the stay Score between 0 and 20 for each part of the test, with 20 being the best score (and therefore the best physical condition).

Secondary Outcomes

  • KidScreen52 quality-of-life scale score.(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Impedance measurement(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Shirado test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Exercise test on ergometer(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • 6-minute walk test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Energy expenditure index(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Anamnesis(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Sorensen test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Floor survey test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • 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.(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • The Canadian Occupational Performance Measure(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Gluteal bridge(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Timed Up and Down Stairs (TUDS) test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • A motivational questionnaire(Day of patient inclusion and 3 months after, day on which the study ends for the patient)

Study Sites (1)

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