Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Assessment of fatigue with Fatigue Severity Scale
研究概览
简要总结
Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Patients who have been seriously ill and have been admitted to the ward with high oxygen mixtures or have been admitted to the ICU will be selected primarily. The program includes supervised rehabilitation sessions 2 times a week for 2 months. Patients will be evaluated during recruitment and at the end of the program. Patients who can not attend the program due to logistical/transport issues will be re-evaluated in 2 months and constitute the control population. Investigators hypothesis is that post COVID-19 patients who have persistent symptoms, including fatigue following a supervised rehabilitation program will have fewer symptoms after the end of the program compared to similar patients who do not attend a rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Candidates for inclusion in the study are:
- •Patients recovering from COVID-19 disease AND suffering from persistent limitations (>=1 month) of their physical activity and reduction of their quality of life and associated symptoms including shortness of breath, fatigue, weakness of the upper and lower extremities, post-traumatic stress, pain, etc.
- •Priority will be given to patients suffering from more symptoms and disabilities. Patients who might suffer more after COVID-19 disease are:
- •Patients admitted to the ICU, especially those who were intubated.
- •Patients who needed high oxygen mixtures (high-flow nasal cannula -HFNC, non-re-breathing mask) as well as those who were older and had prolonged hospitalization.
排除标准
- •Patients who suffer from active disease will not be included until they stop being infectious.
- •Patients treated with COVID-19 infection where the main reason for hospitalization was not the virus infection (e.g. due to coronary heart disease, surgery, etc.) will also be excluded.
- •Patients suffering from dementia,
- •patients with myocarditis
- •patients with thromboembolic disease that receive anticoagulants for less than a month
- •patients chronically paralyzed,
- •patients with paraplegia,
- •patients with multiple injuries
- •patients with serious orthopedic problems that cause disability
- •patients suffering from very serious underlying diseases such as end-stage cancer,
- •patients with neurological diseases that cause disability, require rehabilitation clinics and special interventions (speech therapy, kinesiotherapy, patients with tracheostomy etc.).
结局指标
主要结局
Assessment of fatigue with Fatigue Severity Scale
时间窗: 2 months
Assessment of fatigue using the Fatigue Severity Scale. The minimum score is 9 and maximum score is 63. Higher values mean higher fatigue severity.
Assessment of fatigue with FACIT fatigue Scale
时间窗: 2 months
The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Score range is from 0-52 and the higher the score the better QOL (quality of life).
Assessment of fatigue using chalder fatigue scale.
时间窗: 2 months
The chalder fatigue scale is scored bimodally with a range from 0 to 11 assessing the number of symptoms. It is also scored in Likert style with a range of 0-33 in order to asses the severity of symptoms. The higher the scores indicate more and more severe symptoms.
Assessment of respiratory symptoms after COVID-19 with CAT.
时间窗: 2 months
Assessment of symptoms after COVID-19 using the COPD Assessment Test (CAT). Minimum score is 0 and maximum score is 40. Patients with higher scores are more impaired. Patients with a score of 10 or more are considered significantly impaired after COVID-19 infection.
次要结局
- Assessment of shortness of breath(2 months)
- Assessment of quality of life using SF-36 questionnaire.(2 months)
- Assessment of anxiety and depression with HADS(2 months)
- Assessment of functional capacity with one minute sit to stand test.(2 months)
- Assessment of functional capacity with Short Physical Performance Battery.(2 months)
- Assessment of Post Traumatic Stress Disorder with the Impact of Event Scale revised.(2 months)
- Assessment of lung diffusion capacity.(2 months)
- Assessment of physical activity with IPAQ.(2 months)
- Assessment of lower extremity strength(2 months.)
- Assessment of respiratory function with FVC(2 months)
- Assessment of balance.(2 months)
- Assessment of symptoms after COVID-19 with PCFS.(2 months)
- Assessment of functional capacity with 6MWT.(2 months)
- Assessment of cognitive dysfunction(2 months)
- Assessment of respiratory function with FEV1(2 months)
- Assessment of quality of life using EQ-5D-5L questionnaire.(2 months)
- Assessment of depression with Beck Depression Inventory(2 months)
研究者
Andreas Asimakos
Principal Investigator
Evangelismos Hospital