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临床试验/NCT06347042
NCT06347042尚未招募不适用

Efficacy of Qigong Exercise on Sleep Quality and Heart Rate Variability in Patients With Fibromyalgia

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Sleep quality

研究概览

简要总结

This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia.

详细描述

Fibromyalgia is a disease of unknown and complex an etiopathogenetic, and although pain is its main characteristic, it also stands out for being a disease with multiple symptoms such as fatigue, sleep disorders, anxiety and depressive disorders. For thirty years, various diagnostic criteria, screening and instruments have been developed in the clinical setting, posing a major challenge to researchers and clinicians worldwide. However, the most widely used criterion has been that of the American College of Rheumatology, 1990, as revised in 2016 . The genetic predisposition, environmental triggers and neuromodulation being involved in the onset and course of the disease. The existence of predisposing factors being associated with a high rate of functional disability . FM affects about 5% of the world population. The incidence is higher in women than in men, and the age range in which FM generally appears is between 30 and 35 years. However, FM remains a poorly understood and difficult-to-diagnose condition.

No abnormalities are seen in fibromyalgia in routine clinical laboratory testing or imaging. Functional MRI and other specialized imaging have revealed certain abnormalities in patients with fibromyalgia compared to control subjects.

The subjectivity of the symptoms and the lack of biomarkers, diagnosis is exquisitely clinical, and diagnostic criteria are constantly evolving; early diagnosis and prevention are still elusive goals. Fibromyalgia severity and progression or improvement can be evaluated by means of a plethora of composite tests. Fibromyalgia pathogenesis is not fully understood; hypotheses state that genetic predisposition, stressful life events, peripheral (inflammatory) and central (cognitive-emotional) mechanisms interplay to create pain despeciation owing to neuro-morphological modifications .Treatment should be multimodal and built on four pillars (patient education; fitness; pharmacotherapy; and psychotherapy); the approach should be individualized, symptom-based and stepwise, establishing shared goals with the patient.

Chronic pain and depression exhibit a bidirectional relationship, mediated by neuroplasticity that involves similar brain structures, neurotransmitters, and signaling pathways, leading to both psychological and physical symptoms. Patients with comorbid depression and chronic pain show lower response rates to antidepressants and a higher incidence of suicide attempts than those without chronic pain.

Anxiety and depression are two comorbidities frequently associated with fibromyalgia and chronic pain, being present in 30-50% of patients at the time of disease diagnosis, patients with FM suffer more anxiety and depression than those without the disease . The prevalence of depression in patients with FM is estimated to be between 18 and 36% and between 11.6 and 32.2% for anxiety disorders.

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 (Participant)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients are female
  • Age from 30 to 50 years
  • Body mass index (BMI) from 18.5 to 34.9 kg/m
  • Patients will include if they have been diagnosed with FM by rheumatologists as fulfilling all the ACR criteria (1990, 2011 and 2016)
  • All patients are ambulant independently
  • Stable medication pattern for at least 2 months.

排除标准

  • Presence of any immune diseases or comorbidities that could explain the main symptomatology of FM
  • The presence of brain damage, dementia, or neurological disease.
  • The presence of psychiatric disorders or current major depressive episode
  • Endocrine disorders
  • Fractures in upper limb or lower limb
  • Participation in regular exercise training of any type in the previous 3 months.

结局指标

主要结局

Sleep quality

时间窗: evaluated beginning and through study completion, an average of8 weeks

The Pittsburgh Sleep Quality Index (PSQI): It is used to determine self-reported sleep quality and sleep disturbances for the preceding month. It is a consistent and easy for patients and health-care providers in interpreting the indicators of sleep quality. It is a 19-item test and consists of seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use and (7) daytime dysfunction. Each component is scored from 0 to 3, and , each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. PSQI (poor sleep: global score \> 5

Heart Rate variability

时间窗: evaluated beginning and through study completion, an average of8 weeks short time 5minutes

Smart watch-derived HRV provides a practical alternative with excellent accuracy compared with ECG-based HRV for global markers and those characterizing lower frequency components. However, caution is warranted with HRV markers that predominantly assess short-term variability.

次要结局

  • Quality of Life o measure the quality of life of patients with problems found fibromyalgia.(evaluated beginning and through study completion, an average of8 weeks)
  • Fatigue :prevalence and severity of fatigue(evaluated beginning and through study completion, an average of8 weeks)
  • pain self-administered questionnaire(evaluated beginning and through study completion, an average of8 weeks)
  • Depression and Anxiety assess Depression and Anxiety(evaluated beginning and through study completion, an average of8 weeks)

研究者

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

Alaa Wageih Agwa

Principal Investigator

Cairo University

研究点 (1)

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