跳至主要内容
临床试验/NCT06320496
NCT06320496招募中不适用

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

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Diagnoform test score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Diagnoform test score

时间窗: 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).

次要结局

  • 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)
  • Shirado test(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)
  • 6-minute walk test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Energy expenditure index(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)
  • Sorensen test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Floor survey test(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.(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • The Canadian Occupational Performance Measure(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Gluteal bridge(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • Timed Up and Down Stairs (TUDS) test(Day of patient inclusion and 3 months after, day on which the study ends for the patient)
  • A motivational questionnaire(Day of patient inclusion and 3 months after, day on which the study ends for the patient)

研究者

发起方
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
申办方类型
Other
责任方
Sponsor

研究点 (2)

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