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临床试验/NCT06829940
NCT06829940招募中不适用

Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Pulmonary function: By Spirometry Device:

研究概览

简要总结

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).

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• 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

排除标准

  • •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.

研究组 & 干预措施

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]

干预措施: Baduanjin exercise training (BET) (Other)

waitlist

No Intervention

this group will receive no intervention

结局指标

主要结局

Pulmonary function: By Spirometry Device:

时间窗: 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)

次要结局

  • Pulmonary function: By Spirometry Device:(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)::will be measured at baseline, and it will be measured again after twelve weeks)
  • Modified Borg dyspnea scale (MBDS)(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 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).(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). 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) 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):will be measured at baseline, and it will be measured again after twelve weeks)
  • Beck Depression Inventory (BDI):(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)::will be measured at baseline, and it will be measured again after twelve weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Cairo University

研究点 (1)

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