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NCT Number: 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).

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Key information

Conditions

Chronic COVID-19 Syndrome

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11432, Egypt

Location status: Recruiting

Location contact

Alaa El-Moatasem, lecturer

CONTACT

[email protected]

01006625054

Alaa El-Moatasem, lecturer

PRINCIPAL_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa El-moatasem, lecturer

CONTACT

[email protected]

01006625054

Rania ali, assistant professor

CONTACT

[email protected]

010015931155

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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