Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- 6-minute walk test
研究概览
简要总结
The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.
详细描述
COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation.
Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease.
The patients with COVID-19 with post-intensive care syndrome will be randomized two groups: Tele-rehabilitation group and home exercise group. There will not be a non-exercising control group due to the ethical issues. The exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients.
Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise.
The trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •To be older than 18 years
- •To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19
- •To have ability to walk independently
排除标准
- •To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions
- •To have a severe co-morbidity that exercise is contraindicated
结局指标
主要结局
6-minute walk test
时间窗: 12 months
This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six-minute walking distance will be recorded. Higher walking distance shows better outcome. Minimal clinical difference is 20-30 meter in patients surviving acute respiratory distress syndrome
次要结局
- Chair- stand test(12 months)
- Hand grip strength(12 months)
- Short form - 36(12 months)
- Timed up and go test(12 months)
- St. George's Respiratory Questionnaire(12 months)
- The COPD Assessment Test(12 months)
- Medical Research Council Dyspnea Scale(12 months)