Effect of Intensive Combined Rehabilitation Therapy for Patients With Post COVID 19 Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The fatigue severity level
研究概览
简要总结
The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .
详细描述
A significant proportion of COVID-19 patients are suffering from prolonged Post-COVID-19 Fatigue Syndrome, with characteristics typically found in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). More recent studies of post-COVID-19 patients, over an extended period (6 months or more), have highlighted post-exertional malaise and relapses, both key characteristics of ME/CFS.
With over 147 million confirmed cases of COVID-19 worldwide currently and globally, the number of post-COVID-19 patients with chronic fatigue syndrome like symptoms is likely to be in the order of millions. This will present a worldwide, significant, ongoing health problem. With this impending flow of health crisis, it is hoped more intensive research into post covid chronic fatigue syndrome with a specific focus on study of these illnesses will likely bring significant advances.
Chronic fatigue syndrome is a disabling condition with a high impact on individuals and society, which causes a substantial economic burden. The persistent and debilitating nature of chronic fatigue syndrome often results in a reduction in work and family life activities, as well as an increase in health care costs. Because it becomes difficult for patients with chronic fatigue syndrome to continue employment at morbid levels, many have little choice but to leave their jobs.
Management of fatigue states requires multidisciplinary input and will not be appropriately addressed if follow-up is by treating medical physicians alone. A suite of interventions, including graded exercise and cognitive behavioral therapy, are needed to manage chronic fatigue syndrome and may be relevant to post infectious fatigue.
Research evaluating the efficacy of graded exercise therapy (GET) in alleviating the symptoms of chronic fatigue found that at the end of treatment, the exercise group rated themselves as significantly more improved and less fatigued than the control group. A decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. Graded exercise appears to be an effective treatment for CFS, and it operates in part by reducing the degree to which patients focus on their symptoms.
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 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 post covid patients (6 months recovery after last negative PCR diagnosis)
- •Patients will be selected using the Oxford diagnostic criteria for CFS which required disabling fatigue to be the primary problem, in the absence of an exclusionary medical or psychiatric diagnosis. Patients will fulfil the following criteria for CFS :
- •fatigue as a principal symptom.
- •fatigue definite onset that is not life long.
- •fatigue should have been present for a minimum of 6 months during which it was present for more than 50% of the time.
- •Other symptoms may be present, particularly myalgia, mood and sleep disturbance.
- •Both sexs will be included
- •Body mass index range from (18.5 to 24.9 kg/m2)
- •Patients' age range will be 18 to 34 years old .
- •Presence of significant fatigue since COVID-
- •Able to understand and willing to sign a written informed consent document.
- •Willing and able to complete study procedures.
排除标准
- •On medications that would influence exercise performance such as beta blockers or antiretroviral therapy
- •Enrolled in another interventional clinical research trial
- •Pregnancy
- •Significant hepatic or renal dysfunction
- •History or cardiac condition as determined by National Institutes of Health (NIH) cardiology to be unsafe for exercise participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non-idiopathic cardiomyopathy)
- •Patients with a current diagnosis of schizophrenia, manic depressive illness, substance abuse, eating disorder or proven organic brain disease.
结局指标
主要结局
The fatigue severity level
时间窗: 12 weeks
The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)
aerobic capacity and endurance
时间窗: 12 weeks
Aerobic capacity and endurance will be measured via The 6 Minute Walk Test. The test will be performed at Modern University for the technology and information rehabilitation center corridor.
the Fall risk
时间窗: 12 weeks
Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).
Maximal hand grip strength and fatigue resistance
时间窗: 12 weeks
Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer
次要结局
未报告次要终点
研究者
Samar Hosny
Assistant lecturer
Cairo University