Chronic COVID-19 SyndromeNCT06829940
Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
A study testing Baduanjin exercise training (BET) in people with Chronic COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Post-COVID recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. The unpleasant symptoms of chronic post-viral/post-COVID syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic COVID-19 Syndrome
- What is being tested?
- Baduanjin exercise training (BET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 40 patients will be recruited in the study.
- age ≥ 18 to ≤ 50 years old
- achieved three diagnostic items/criteria of ICF will be included in this BET trial: Fatigue lasting over 6 months, which significantly limits daily activities, reducing the person's usual activity level by more than 50%, as confirmed by a doctor.
- At least three of the following symptoms:
- Generalized muscle weakness Difficulty sleeping Frequent headaches A painful throat Muscle tenderness throughout the body Migratory joint pain Swollen lymph nodes in the neck or armpits Fatigue lasting more than a day after typical activities
Who cannot join
- Patients with a history of medical or complementary treatments for ICF disorder in the 6 months before contracting COVID or after recovery.
- Individuals who have engaged in therapeutic exercise, pharmacological treatments, or complementary therapies for post-COVID symptoms within the last six months prior to enrollment.
- ICF patients regularly using antidepressants or antipsychotics were excluded.
- Those who take sleeping pills regularly were also excluded.
- Patients with autoimmune diseases, malignant conditions, anemia, endocrine disorders, systemic diseases, or osteoarthritis affecting the cervical spine, lumbar region, or limbs were excluded.
- Individuals with abnormal results in laboratory tests, including neurological, neurophysiological, cardiological, liver/kidney function tests, or urine/stool analyses (as determined by a physician) were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11432
Alaa El-Moatasem, lecturer, 01006625054, alaamotasem@cu.edu.eg
Alaa El-Moatasem, lecturer
About this study
Post-COVID recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. The unpleasant symptoms of chronic post-viral/post-COVID syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or depression, and insomnia or sleep disturbances) usually magnify the symptoms of already existing previously diagnosed concurrent untreatable chronic disorders , including the idiopathic chronic fatigue (ICF).(Leszczak et al., 2024)
Baduanjin exercise training (BET) is one of the Chinese traditional Health-Qigong exercises that not only integrate slow coordinating postures/positions, breathing techniques, musculoskeletal stretching movements/positions, and meditative mind but also plays a strong role concerning health benefits (e.g. musculoskeletal pain-reducing, sleep disturbance-enhancing effects, and fatigue-reducing effects) (Zou et al., 2018).
Read the detailed description
forty idiopathic chronic fatigue (ICF) patients will be randomly assigned into two equal groups (n=20)
- Study group (20 patients) this group will be supervised daily, except Fridays, during the 60-minute session of 12-week BET) or waitlist group
- Control group (20 patients)
- Conditions
- Chronic COVID-19 Syndrome
- Being tested
- Baduanjin exercise training (BET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exercise training (BET)Other
Baduanjin Exercise Training (BET) is a traditional Chinese exercise focused on improving physical health, flexibility, balance, and mental well-being. It involves a 10-minute warm-up, a 40-minute core session practicing eight distinct postures, and a 10-minute cool-down. The postures, based on the Baduanjin form, target different body parts and promote strength, flexibility, and circulation. The exercises are synchronized with deep breathing to enhance relaxation and stress reduction. BET is especially beneficial for joint health, mobility, and mental clarity, making it suitable for individuals of all ages and fitness levels
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise training | Experimental | Each BET session consisted of a 10-minute warm-up and a 10-minute cool-down period [Xia et al., 2023]. These were followed by a 40-minute BET segment, which typically involved eight distinct body postures. These postures are based on the "Health Qigong Baduanjin Standard," as outlined in Zhao et al. [2019] and Koh [1982]. The eight postures are: (1) Support the Heaven, (2) Draw a Bow to Each Side, (3) Hold Up a Single Hand, (4) Practice Looking Back, (5) Shake the Hand and Wag the Tail, (6) Touch the Feet with Both Hands, (7) Climbing with Both Hands, and (8) Relax the Back, as explained in Zeng et al. [2020] Receives: Other: Baduanjin exercise training (BET) |
| waitlist | No intervention | this group will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function: By Spirometry Device:
- Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)
Measured: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again
Secondary outcomes (10)
Pulmonary function: By Spirometry Device:
Pulmonary function: By Spirometry Device: it measure ventilatory functions forced expiratory volume in one second (FEV1)
Measured: By Spirometry Device forced expiratory volume in one second (FEV1) will be measured at baseline, and it will be measured after twelve weeks again
Measuring functional capacity: By Six-minute walk test (6MWT)
Measuring functional capacity: By Six-minute walk test (6MWT): is a self paced submaximal field exercise test , It will be performed according to the standard procedure is administered in a 30 meter hallway. (Launois et al., 2012 and ATS statement2002)
Measured: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after twelve weeks
Modified Borg dyspnea scale (MBDS)
Modified Borg dyspnea scale (MBDS) is patient self-reported measures of one's difficulty in breathing upon exertion
Measured: Modified Borg dyspnea scale (MBDS) will be measured at baseline, and it will be measured again after twelve weeks
Strength of lower limb muscles By a thirty-second sit-to-stand test
thirty-second sit-to-stand test was designed for testing leg strength and endurance it is the number of repetitions of sit-to-stand action executed in thirty seconds
Measured: thirty-second sit-to-stand test will be measured at baseline, and it will be measured again after twelve weeks
Endurance of upper limb muscles: by the maximal repetitions of push-ups (MRPU).
Endurance of upper limb muscles: by the maximal repetitions of push-ups (MRPU) is commonly used to assess upper body strength, muscular endurance, and overall fitness levels.
Measured: the maximal repetitions of push-ups (MRPU). will be measured at baseline, and it will be measured again after twelve weeks
Cardiorespiratory fitness:by the index of Ruffier test (IRT).
Cardiorespiratory fitness: by the index of Ruffier test (IRT). is a simple, non-invasive method used to assess the recovery capacity of the heart after exercise and can be used to monitor fitness improvements over time.
Measured: Cardiorespiratory fitness:by the index of Ruffier test (IRT). will be measured at baseline, and it will be measured again after twelve weeks
Quality of life: by the short form 36 questionnaire (SF)
Quality of life: by the short form 36 questionnaire (SF) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used
Measured: Quality of life: by the short form 36 questionnaire (SF) will be measured at baseline, and it will be measured again after twelve weeks
sleep quality by Pittsburgh sleep quality index (PSQI):
sleep quality by Pittsburgh sleep quality index (PSQI): This is a 19 item widely used self-report questionnaire designed to assess sleep quality and disturbances
Measured: sleep quality by Pittsburgh sleep quality index (PSQI):will be measured at baseline, and it will be measured again after twelve weeks
Beck Depression Inventory (BDI):
Beck Depression Inventory (BDI):widely used self-report questionnaire designed to assess the presence and severity of depressive symptoms
Measured: Beck Depression Inventory (BDI):will be measured at baseline, and it will be measured again after twelve weeks
fatigue assessment by Buzhongyiqi-Tang questionnaire (BZTQ):
Buzhongyiqi-Tang questionnaire (BZTQ): Fatigue syndrome's severity can be rated via this validated 16-item questionnaire (every item was rated 7-Likert scale responses starting from zero to seven).
Measured: Buzhongyiqi-Tang questionnaire (BZTQ)::will be measured at baseline, and it will be measured again after twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start9 Oct 2024
- Primary completion22 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed El-Moatasem Mohamed, Cairo University
- Investigators
- Alaa El-moatasem, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829940
- Sponsor's protocol ID
- P.T.REC/012/005517
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
- ClinicalTrials.gov ID
- NCT06829940
- Acronym / sponsor ID
- P.T.REC/012/005517
- Conditions
- Chronic COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 22 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
Post-COVID recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. The unpleasant symptoms of chronic post-viral/post-COVID syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or depression, and insomnia or sleep disturbances) usually magnify the symptoms of already existing previously diagnosed concurrent untreatable chronic disorders , including the idiopathic chronic fatigue (ICF).(Leszczak et al., 2024)
Baduanjin exercise training (BET) is one of the Chinese traditional Health-Qigong exercises that not only integrate slow coordinating postures/positions, breathing techniques, musculoskeletal stretching movements/positions, and meditative mind but also plays a strong role concerning health benefits (e.g. musculoskeletal pain-reducing, sleep disturbance-enhancing effects, and fatigue-reducing effects) (Zou et al., 2018).
Detailed description
forty idiopathic chronic fatigue (ICF) patients will be randomly assigned into two equal groups (n=20)
- Study group (20 patients) this group will be supervised daily, except Fridays, during the 60-minute session of 12-week BET) or waitlist group
- Control group (20 patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise training | Experimental | Other: Baduanjin exercise training (BET)Each BET session consisted of a 10-minute warm-up and a 10-minute cool-down period [Xia et al., 2023]. These were followed by a 40-minute BET segment, which typically involved eight distinct body postures. These postures are based on the "Health Qigong Baduanjin Standard," as outlined in Zhao et al. [2019] and Koh [1982]. The eight postures are: (1) Support the Heaven, (2) Draw a Bow to Each Side, (3) Hold Up a Single Hand, (4) Practice Looking Back, (5) Shake the Hand and Wag the Tail, (6) Touch the Feet with Both Hands, (7) Climbing with Both Hands, and (8) Relax the Back, as explained in Zeng et al. [2020] |
| waitlist | No intervention | –this group will receive no intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • 40 patients will be recruited in the study.
- Generalized muscle weakness Difficulty sleeping Frequent headaches A painful throat Muscle tenderness throughout the body Migratory joint pain Swollen lymph nodes in the neck or armpits Fatigue lasting more than a day after typical activities
Key exclusion criteria (6 listed)
- Patients with a history of medical or complementary treatments for ICF disorder in the 6 months before contracting COVID or after recovery.
- Individuals who have engaged in therapeutic exercise, pharmacological treatments, or complementary therapies for post-COVID symptoms within the last six months prior to enrollment.
- ICF patients regularly using antidepressants or antipsychotics were excluded.
- Those who take sleeping pills regularly were also excluded.
- Patients with autoimmune diseases, malignant conditions, anemia, endocrine disorders, systemic diseases, or osteoarthritis affecting the cervical spine, lumbar region, or limbs were excluded.
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 |
|---|---|---|
| Baduanjin exercise training (BET)Baduanjin Exercise Training (BET) is a traditional Chinese exercise focused on improving physical health, flexibility, balance, and mental well-being. It involves a 10-minute warm-up, a 40-minute core session practicing eight distinct postures, and a 10-minute cool-down. The postures, based on the Baduanjin form, target different body parts and promote strength, flexibility, and circulation. The exercises are synchronized with deep breathing to enhance relaxation and stress reduction. BET is especially beneficial for joint health, mobility, and mental clarity, making it suitable for individuals of all ages and fitness levels | Other | Baduanjin exercise training |
Primary outcome
Pulmonary function: By Spirometry Device:
Time frame: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again
• Pulmonary function: By Spirometry Device: it measure ventilatory functions. forced vital capacity (FVC)
10 secondary outcomes
Pulmonary function: By Spirometry Device:
Time frame: By Spirometry Device forced expiratory volume in one second (FEV1) will be measured at baseline, and it will be measured after twelve weeks again
Measuring functional capacity: By Six-minute walk test (6MWT)
Time frame: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after twelve weeks
Modified Borg dyspnea scale (MBDS)
Time frame: Modified Borg dyspnea scale (MBDS) will be measured at baseline, and it will be measured again after twelve weeks
Strength of lower limb muscles By a thirty-second sit-to-stand test
Time frame: thirty-second sit-to-stand test will be measured at baseline, and it will be measured again after twelve weeks
Endurance of upper limb muscles: by the maximal repetitions of push-ups (MRPU).
Time frame: the maximal repetitions of push-ups (MRPU). will be measured at baseline, and it will be measured again after twelve weeks
Cardiorespiratory fitness:by the index of Ruffier test (IRT).
Time frame: Cardiorespiratory fitness:by the index of Ruffier test (IRT). will be measured at baseline, and it will be measured again after twelve weeks
Quality of life: by the short form 36 questionnaire (SF)
Time frame: Quality of life: by the short form 36 questionnaire (SF) will be measured at baseline, and it will be measured again after twelve weeks
sleep quality by Pittsburgh sleep quality index (PSQI):
Time frame: sleep quality by Pittsburgh sleep quality index (PSQI):will be measured at baseline, and it will be measured again after twelve weeks
Beck Depression Inventory (BDI):
Time frame: Beck Depression Inventory (BDI):will be measured at baseline, and it will be measured again after twelve weeks
fatigue assessment by Buzhongyiqi-Tang questionnaire (BZTQ):
Time frame: Buzhongyiqi-Tang questionnaire (BZTQ)::will be measured at baseline, and it will be measured again after twelve weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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.
Alaa El-moatasem, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise training (BET) in people with Chronic COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa El-moatasem, lecturer (01006625054, alaamotasem@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function: By Spirometry Device: (time frame: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.