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临床试验/NCT06832709
NCT06832709招募中不适用

Etat Des Lieux de la santé Physique, Sociale et Psychologique Des Aidants Dans le Cadre Des Maladies Respiratoires Chroniques

Lille University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
functional capacity

研究概览

简要总结

The ageing of the population is accompanied by an increase in the frequency of chronic illnesses, leading to a rise in the number of caregivers. These caregivers do not have the time to look after their own health, and they are very often in a deteriorated mental state with no knowledge of their level of fitness. A deterioration in their fitness can be a source of the development of diseases induced by a sedentary lifestyle. On the other hand, patients with chronic respiratory disease can benefit from respiratory rehabilitation (RR), which includes outpatient or home-based physical activity. The literature has demonstrated an improvement in the mental state of caregivers following a RR carried out by their loved ones without taking an interest in their fitness. The aim of the study will be to establish 1. a representation of the level of fitness and mental state of caregivers; 2. to assess the presence/absence of benefits on fitness and mental state of caregivers depending on the form of RR: home versus outpatient where the caregiver is not integrated in this last form.

详细描述

The literature reports more anxiety and depressive symptoms , a greater psychological and social burden and a poorer quality of life in caregivers than in their non-caregivers peers. Knowing the fitness of caregivers, by means of an assessment of their abilities, would make it possible to define their profile, which should reflect an altered fitness linked to a state of ill-being. The results of these assessments would make it possible to establish a prevention policy, and following a rehabilitation programme for their patients, their health should improve. For caregivers who agree to take part in the study, their physical, mental and social health will be assessed. The total duration of the visit, including all the assessments, is estimated at 1h30. We expect the fitness and mental and social state of all the caregivers to deteriorate in line with the indicators available in the literature for people of the same age who are not carers. Following care of the patients, we expect an improvement in fitness and mental state of the carers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Be of legal age;
  • Have a sick relative taking part in a RR program, either as an outpatient at the Clinique de la Mitterie or at home with FormAction Santé;
  • Have the cognitive ability to understand the instructions for carrying out the physical tests and the questions for answering the questionnaires;
  • Be able to read;
  • Have no disability preventing them from carrying out the physical tests;
  • Have given their written consent to take part in the research;
  • Be willing to comply with all the research procedures and duration.

排除标准

  • Refusal to sign consent;
  • Operation less than one month old;
  • Presence of psychological or psychiatric disorders;
  • Impossibility of receiving informed information;
  • Impossibility of participating in the entire study;
  • Contraindication to physical activity.

研究组 & 干预措施

a program of rehabilitation in a specialized center

Active Comparator

group of caregivers which their loved ones followed a program of rehabilitation in a specialized center

干预措施: a program of rehabilitation (Other)

program of rehabilitation at home

Experimental

group of caregivers which their loved ones followed a program of rehabilitataion at home

结局指标

主要结局

functional capacity

时间窗: 8 weeks

achieve the highest number of steps on a stepper in 6 minutes

次要结局

  • assessments of fitness(8 weeks)
  • Short battery physical fitness test(8 weeks)
  • Assessment of the state of health felt by the two parts of the EuroQol Group questionnaire (1990),(8 weeks)
  • Physical and mental fatigue questionnaire (Michielsen et al. 2003)(8 weeks)
  • Charlson Comorbidity Score(8 weeks)
  • Visual analog scales to measure shortness of breath and fatigue felt in the legs(8 weeks)
  • Questionnaire on the Perceived Social Burden of Caregivers (Zarit et al., 1986)(8 weeks)
  • Anxiety and Depression Symptoms Questionnaire (Zigmond et al. 1983)(8 weeks)
  • EPICES social insecurity questionnaire (Sass et al. 2006)(8 weeks)

研究者

发起方
Lille University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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