Post-COVID-19 SyndromeNCT05534997
Rehabilitation Therapy for Post COVID 19 Chronic Fatigue Syndrome
A study testing intensive combined rehabilitation therapy in people with Post-COVID-19 Syndrome, run by Cairo University.
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 . Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- intensive combined rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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-19.
- Able to understand and willing to sign a written informed consent document.
- Willing and able to complete study procedures.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intensive Combined Rehabilitation Therapy for Patients With Post COVID 19 Chronic Fatigue Syndrome
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 .
Read the detailed 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 .
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- intensive combined rehabilitation therapy
- Keywords
- chronic fatigue, graded exercise, cognitive behavioral therapy
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive combined rehabilitation therapyOther
graded exercise therapy and cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | will receive the post covid protocol conventional treatment in form of medication and 24 sessions of combined rehabilitation exercise program in the form of Graded exercise therapy (GET) and cognitive behavioral therapy (CBT). Patients will attend two sessions per week for 12 weeks. Sessions will be taken at Modern university for technology and information physical therapy rehabilitation center . A home exercise program will be prescribed on at least five days a week. Patients will be contacted by phone daily for the 12 weeks treatment sessions, for following up the home exercise program. Receives: Other: intensive combined rehabilitation therapy |
| Group B | No intervention | will receive the post covid protocol conventional treatment in form of medication and specialist medical care provided by doctors with specialist experience in CFS. All patients will be given a leaflet explaining the illness and the nature of this treatment. Treatment will consist of an explanation of chronic fatigue syndrome, generic advice such as to avoid extremes of activity and rest, specific advice on self-help and symptomatic pharmacotherapy (especially for insomnia, pain and mood) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fatigue severity level
The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)
Measured: 12 weeks
aerobic capacity and endurance
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.
Measured: 12 weeks
Maximal hand grip strength and fatigue resistance
Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer
Measured: 12 weeks
the Fall risk
Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre and post test parallel groups randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534997
- Sponsor's protocol ID
- Chronic fatigue syndrome
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
PubMed 32784198Elboim-Gabyzon M, Buxbaum R, Klein R. The Effects of High-Intensity Interval Training (HIIT) on Fall Risk Factors in Healthy Older Adults: A Systematic Review. Int J Environ Res Public Health. 2021 Nov 11;18(22):11809. doi: 10.3390/ijerph182211809.
PubMed 34831565Dennis A, Wamil M, Alberts J, Oben J, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Brady M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A; COVERSCAN study investigators. Multiorgan impairment in low-risk individuals with post-COVID-19 syndrome: a prospective, community-based study. BMJ Open. 2021 Mar 30;11(3):e048391. doi: 10.1136/bmjopen-2020-048391.
PubMed 33785495Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997 Mar;154(3):408-14. doi: 10.1176/ajp.154.3.408.
PubMed 9054791
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Combined Rehabilitation Therapy for Patients With Post COVID 19 Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT05534997
- Acronym / sponsor ID
- Chronic fatigue syndrome
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- chronic fatigue, graded exercise, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pre and post test parallel groups randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: intensive combined rehabilitation therapywill receive the post covid protocol conventional treatment in form of medication and 24 sessions of combined rehabilitation exercise program in the form of Graded exercise therapy (GET) and cognitive behavioral therapy (CBT). Patients will attend two sessions per week for 12 weeks. Sessions will be taken at Modern university for technology and information physical therapy rehabilitation center . A home exercise program will be prescribed on at least five days a week. Patients will be contacted by phone daily for the 12 weeks treatment sessions, for following up the home exercise program. |
| Group B | No intervention | –will receive the post covid protocol conventional treatment in form of medication and specialist medical care provided by doctors with specialist experience in CFS. All patients will be given a leaflet explaining the illness and the nature of this treatment. Treatment will consist of an explanation of chronic fatigue syndrome, generic advice such as to avoid extremes of activity and rest, specific advice on self-help and symptomatic pharmacotherapy (especially for insomnia, pain and mood) . |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 :
- 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 .
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive combined rehabilitation therapygraded exercise therapy and cognitive behavioral therapy | Other | Group A |
Primary outcome
The fatigue severity level
Time frame: 12 weeks
The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)
aerobic capacity and endurance
Time frame: 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.
Maximal hand grip strength and fatigue resistance
Time frame: 12 weeks
Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer
the Fall risk
Time frame: 12 weeks
Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 32784198Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
- Background: PubMed 34831565Elboim-Gabyzon M, Buxbaum R, Klein R. The Effects of High-Intensity Interval Training (HIIT) on Fall Risk Factors in Healthy Older Adults: A Systematic Review. Int J Environ Res Public Health. 2021 Nov 11;18(22):11809. doi: 10.3390/ijerph182211809.
- Background: PubMed 33785495Dennis A, Wamil M, Alberts J, Oben J, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Brady M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A; COVERSCAN study investigators. Multiorgan impairment in low-risk individuals with post-COVID-19 syndrome: a prospective, community-based study. BMJ Open. 2021 Mar 30;11(3):e048391. doi: 10.1136/bmjopen-2020-048391.
- Background: PubMed 9054791Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997 Mar;154(3):408-14. doi: 10.1176/ajp.154.3.408.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing intensive combined rehabilitation therapy in people with Post-COVID-19 Syndrome, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Hosny, M.Sc. in Physical Therapy (+201207677743, samarhosnipt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fatigue severity level (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534997, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.