Evaluation of the Effect of a Physical Activity Recovery Stay

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06320496
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Children with Cerebral Palsy, Children with Cancer
Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nancy, France

Status

Recruiting

Address

Institut Régional de Médecine Physique et de Réadaptation

Nancy, , 54000

Site Contact

Jonathan Pierret, PhD

[email protected]

+33 3 82 52 6761

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