Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
研究概览
简要总结
Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.
详细描述
In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.
This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Age above 18 years
- •Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
- •Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months
- •Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
- •Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
- •Asthenia score (Pichot asthenia scale) > 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score <8) and/or
- •Weight loss > 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
- •BMI (Body Mass Index) < 20 (if age < 70 years) or < 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age < 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
- •Patient affiliated to social security system
- •Patient gave written informed consent
排除标准
- •Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
- •Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
- •Patient living in a residential facility for dependent elderly people
- •Patient not speaking french
- •Pregnant women
结局指标
主要结局
Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
时间窗: 1 month
Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)
次要结局
- Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities(1 month)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life(6 months)
- Patient's opinion concerning the rehabilitation program(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities(1 month)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression(6 months)
- Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption(6 months)