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NCT Number: NCT06320496

Evaluation of the Effect of a Physical Activity Recovery Stay

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.

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Key information

Conditions

Children with Cerebral Palsy Children With Cancer

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location status: Recruiting

Location contact

Jonathan Pierret, PhD

CONTACT

[email protected]

+33 3 82 52 6761

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

    Quality of life scale : a T-score value is calculated. Scores range from 10 to 50, where 10 represents the lowest possible value and thus a very low health-related quality of life and 50 the maximum value, i.e. a very high health-related quality of life.

  2. Impedance measurement

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

    Recording weight on a balance : Ideally, the patient should have lost weight by the end of the reconditioning stay.

  3. Exercise test on ergometer

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

    Three-minute warm-up without resistance, then increase in difficulty every minute until you reach 80% of your theoretical maximum heart rate.

  4. Anamnesis

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

    description of the antecedents

  5. 6-minute walk test

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

    Walk the maximum distance for 6 minutes

  6. Energy expenditure index

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

    Functional walking index calculated during a regular, spontaneous 5-minute walk. This index is equal to the ratio of heart rate averaged over the 5th minute to walking speed.

  7. Gluteal bridge

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

    Physical exercise that helps to strengthen the gluteus muscles (located in the buttocks) and hamstrings. The longer you hold the position, the better is.

  8. Shirado test

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

    Assessment of abdominal endurance: keep your shoulders off the ground while lying on your back with your feet raised. The maximum duration of this test is three minutes. Low performance if time less than 60 seconds, maximum if time greater than 150 seconds.

  9. Sorensen test

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

    Assessment of trunk extensor endurance: hold the weight of your trunk in isometric position for as long as possible, with your arms crossed over your chest. The maximum duration of this test is 240 seconds. The longer the position is maintained, the better.

  10. 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

    he participant stands 1 foot from the bottom of a 14-step flight of stairs. The participant is instructed to "Quickly, but safely go up the stairs, turn around on the top step (landing) and come all the way down until both feet land on the bottom step (landing." The participants are allowed to choose any method of traversing the stairs. The TUDS score was the time in seconds from the "go" cue until the second foot returned to the bottom landing. Shorter times indicated better functional ability.

  11. Floor survey test

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

    Evaluation and exercise element designed to teach the subject to get up from the ground using the righting sequence

  12. 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

    Clinical assessment of postural control

  13. The Canadian Occupational Performance Measure

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

    Tool used in occupational therapy to identify people's occupational problems

  14. A motivational questionnaire

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

    A tool for assessing involvement and motivation levels : 7 questions score between 0 and 10. 0 = no motivation 10 = total motivation

Study contacts

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

Jonathan Pierret, PhD

CONTACT

[email protected]

+33 3 82 52 6761

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2024
Registry last updated
May 8, 2026

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

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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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