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Recruiting NCT06320496

Evaluation of the Effect of a Physical Activity Recovery Stay

Observational Children With Cerebral Palsy Children With Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Children With Cerebral Palsy, Children With Cancer. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Diagnoform test score [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
Secondary outcome measures (12)
  • KidScreen52 quality-of-life scale score. [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Impedance measurement [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Exercise test on ergometer [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Anamnesis [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • 6-minute walk test [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Energy expenditure index [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Gluteal bridge [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Shirado test [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Sorensen test [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Timed Up and Down Stairs (TUDS) test [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]
  • Floor survey test [Time frame: 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. [Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient]

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

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

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Institut Régional de Médecine Physique et de Réadaptation — Nancy

Identifiers

NCT: NCT06320496 · IRR-FLAVIGNY-2021-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗