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Clinical Trial Summary

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 .


Clinical Trial Description

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. Regarding several RCTs, a systematic review concluded that cognitive-behavioral therapy (CBT) interventions showed promising results, appearing to reduce fatigue and improve physical functioning. A Cochrane review on cognitive behavioral therapy in adults with chronic fatigue syndrome stated that cognitive-behavioral therapy (CBT) is effective in reducing the symptoms of fatigue at post treatment compared with usual care, and maybe more effective in reducing fatigue symptoms compared with other psychological therapies. Fifteen studies were included in the review. When comparing cognitive-behavioral therapy (CBT) with usual care, the difference in fatigue means scores at post treatment was highly significant in favor of that of cognitive-behavioral therapy (CBT) , with 40% of CBT showing clinical response in contrast with 26% in usual care. A systematic review of randomized controlled trials of treatments for chronic fatigue syndrome found that graded exercise therapy (GET) and cognitive-behavioral therapy (CBT) are effective for patients with chronic fatigue syndrome, the overall results of studies suggested a significant positive effect on fatigue, symptoms and improvements in measures of physical function. Graded exercise works best for chronic fatigue syndrome (CFS) when combined with cognitive-behavioral therapy (CBT). Training studies of High-intensity interval training (HIIT) have revealed more favorable results in a variety of physiological outcomes when compared with traditional continuous training . High-intensity interval training (HIIT) has been shown to be safe and to produce improvements in quality of life . Participants have also reported HIIT to be more enjoyable than moderate-intensity continuous training . Previous studies have indicated that high-intensity interval training (HIIT) was an effective exercise for the enhancement of aerobic and anaerobic capacity . This phenomenon is attributed to increases in the heart's pumping capacity and the mitochondrial activity . Increased aerobic capacity is related to health benefits such as longer lifespan, functional independence, psychological well-being, and quality of life . High-intensity interval training ( HIIT) appears to be a safe and well-tolerated supplement to proven fall prevention programs, due to its effects on lower limb strength reflected in functional performance tests, and on dynamic balance and subjective balance perception . So high-intensity interval training ( HIIT) will be included, as part of Graded exercise therapy GET in our study. No available research work investigates the effect of Cognitive Behavioral Therapy (CBT) and graded exercise therapy (GET) on post COVID-19 chronic fatigue syndrome. So 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 COVID-19 chronic fatigue syndrome . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05534997
Study type Interventional
Source Cairo University
Contact Samar Hosny, M.Sc. in Physical Therapy
Phone +201207677743
Email samarhosnipt@gmail.com
Status Not yet recruiting
Phase N/A
Start date October 1, 2022
Completion date October 1, 2023

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