Evaluation of the Effect of a Physical Activity Recovery Stay

Children With Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320496
• Other study ID #: IRR-FLAVIGNY-2021-2
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: Jonathan Pierret, PhD
• Phone: +33 3 82 52 6761
• Email: jonathan.pierret[@]ugecam.assurance-maladie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children With Cancer
• Children With Cerebral Palsy

Locations

Country	Name	City	State
France	Institut Régional de Médecine Physique et de Réadaptation	Nancy

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	KidScreen52 quality-of-life scale score.	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.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Impedance measurement	Recording weight on a balance : Ideally, the patient should have lost weight by the end of the reconditioning stay.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Exercise test on ergometer	Three-minute warm-up without resistance, then increase in difficulty every minute until you reach 80% of your theoretical maximum heart rate.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Anamnesis	description of the antecedents	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	6-minute walk test	Walk the maximum distance for 6 minutes	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Energy expenditure index	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.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Gluteal bridge	Physical exercise that helps to strengthen the gluteus muscles (located in the buttocks) and hamstrings. The longer you hold the position, the better is.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Shirado test	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.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Sorensen test	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.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Timed Up and Down Stairs (TUDS) test	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.	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	Floor survey test	Evaluation and exercise element designed to teach the subject to get up from the ground using the righting sequence	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	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.	Clinical assessment of postural control	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	The Canadian Occupational Performance Measure	Tool used in occupational therapy to identify people's occupational problems	Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary	A motivational questionnaire	A tool for assessing involvement and motivation levels : 7 questions score between 0 and 10. 0 = no motivation 10 = total motivation	Day of patient inclusion and 3 months after, day on which the study ends for the patient