NCT06320496

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

February 5, 2024

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnoform test score

    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).

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

Secondary Outcomes (14)

  • 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

  • Exercise test on ergometer

    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

  • 6-minute walk test

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

  • +9 more secondary outcomes

Study Arms (1)

Deconditioning to physical exertion

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.

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 20, 2024

Study Start

March 22, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations