- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829940
Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alaa El-Moatasem, lecturer
- Phone Number: 01006625054
- Email: alaamotasem@cu.edu.eg
Study Contact Backup
- Name: Rania ali, assistant professor
- Phone Number: 010015931155
- Email: roni.diamond8@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 11432
- Recruiting
- Cairo University
-
Contact:
- Alaa El-Moatasem, lecturer
- Phone Number: 01006625054
- Email: alaamotasem@cu.edu.eg
-
Principal Investigator:
- Alaa El-Moatasem, lecturer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Baduanjin exercise training
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]
|
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
|
|
No Intervention: waitlist
this group will receive no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Pulmonary function: By Spirometry Device: it measure ventilatory functions forced expiratory volume in one second (FEV1)
|
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
|
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)
|
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
|
Modified Borg dyspnea scale (MBDS) is patient self-reported measures of one's difficulty in breathing upon exertion
|
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
|
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
|
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
|
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.
|
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
|
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.
|
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
|
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
|
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
|
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
|
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
|
Beck Depression Inventory (BDI):widely used self-report questionnaire designed to assess the presence and severity of depressive symptoms
|
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
|
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).
|
Buzhongyiqi-Tang questionnaire (BZTQ)::will be measured at baseline, and it will be measured again after twelve weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alaa El-moatasem, lecturer, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005517
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic COVID-19 Syndrome
-
RSUP PersahabatanCompletedPost COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID Syndrome Long CovidIndonesia
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingLong COVID | Post COVID Syndrome | Long COVID-19 Syndrome | Long COVID SyndromeNetherlands
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
StemCyte, Inc.AvailableLong COVID | Post-COVID Syndrome | Chronic Fatigue | Post-COVID-19 Condition | Fatigue Post Viral | Post-COVID Condition | Chronic Fatigue SymptomsUnited States
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
University of New MexicoUnited States Department of Defense; The Mind Research NetworkRecruitingLong COVID | Long COVID-19 Syndrome | Long COVID Syndrome | PASC Post Acute Sequelae of COVID 19 | PASCUnited States
Clinical Trials on Baduanjin exercise training (BET)
-
Cairo UniversityRecruitingChronic Periodontal DiseaseEgypt
-
Istanbul University - CerrahpasaRecruitingHeart Diseases | Hypertrophic CardiomyopathyTurkey
-
Akdeniz UniversityCompletedQuality of Life | Postoperative Pain | Muscle Weakness | Pain, Shoulder | Respiratory Function Loss | Joint AdhesionTurkey
-
Marmara UniversityCompletedPulmonary Fibrosis, IdiopathicTurkey
-
University of Southern QueenslandNot yet recruitingBreast Cancer SurvivorChina
-
Cairo UniversityRecruiting
-
Cairo UniversityRecruiting
-
Guangdong Provincial Hospital of Traditional Chinese...Unknown
-
Liu QiangZhejiang Provincial People's Hospital; The Third Affiliated hospital of Zhejiang... and other collaboratorsNot yet recruitingCoronary Artery Disease | Percutaneous Coronary Intervention | Myocardial Revascularization
-
China National Center for Cardiovascular DiseasesNot yet recruitingCardiac Rehabilitation | Vascular Health | M-health | Mind-body Exercise