Clinical trial NCT06829940: Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
Official title: Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic COVID-19 Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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)

1. Study group (20 patients) this group will be supervised daily, except Fridays, during the 60-minute session of 12-week BET) or waitlist group
2. Control group (20 patients)

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary function: By Spirometry Device:
timeFrame: By Spirometry Device: forced vital capacity will be measured at baseline, and it will be measured after twelve weeks again
Secondary outcomes:
measure: Pulmonary function: By Spirometry Device:
timeFrame: By Spirometry Device forced expiratory volume in one second (FEV1) will be measured at baseline, and it will be measured after twelve weeks again
measure: Measuring functional capacity: By Six-minute walk test (6MWT)
timeFrame: Measuring functional capacity: By Six-minute walk test (6MWT)::will be measured at baseline, and it will be measured again after twelve weeks
measure: Modified Borg dyspnea scale (MBDS)
timeFrame: Modified Borg dyspnea scale (MBDS) will be measured at baseline, and it will be measured again after twelve weeks
measure: Strength of lower limb muscles By a thirty-second sit-to-stand test
timeFrame: thirty-second sit-to-stand test will be measured at baseline, and it will be measured again after twelve weeks
measure: Endurance of upper limb muscles: by the maximal repetitions of push-ups (MRPU).
timeFrame: the maximal repetitions of push-ups (MRPU). will be measured at baseline, and it will be measured again after twelve weeks
measure: Cardiorespiratory fitness:by the index of Ruffier test (IRT).
timeFrame: Cardiorespiratory fitness:by the index of Ruffier test (IRT). will be measured at baseline, and it will be measured again after twelve weeks
measure: Quality of life: by the short form 36 questionnaire (SF)
timeFrame: Quality of life: by the short form 36 questionnaire (SF) will be measured at baseline, and it will be measured again after twelve weeks
measure: sleep quality by Pittsburgh sleep quality index (PSQI):
timeFrame: sleep quality by Pittsburgh sleep quality index (PSQI):will be measured at baseline, and it will be measured again after twelve weeks
measure: Beck Depression Inventory (BDI):
timeFrame: Beck Depression Inventory (BDI):will be measured at baseline, and it will be measured again after twelve weeks
measure: fatigue assessment by Buzhongyiqi-Tang questionnaire (BZTQ):
timeFrame: Buzhongyiqi-Tang questionnaire (BZTQ)::will be measured at baseline, and it will be measured again after twelve weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Alaa El-moatasem, lecturer
role: PRINCIPAL_INVESTIGATOR
References: