Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347042
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-08
Brief Title:
Effect of Qigong on Sleep Quality in Fibromyalgia
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Efficacy of Qigong Exercise on Sleep Quality and Heart Rate Variability in Patients With Fibromyalgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia
Detailed Description:
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 116 and 322 for anxiety disorders
Chronic pain and poor sleep primary insomnia provoke persistent stress-immune activation Given the evidential effects on quality of life and other medical and psychiatric manifestations that chronic pain and insomnia each have and the notable pain-sleep connections an exaggerated combined effect
Poor sleep is reported by almost 80 of patients with fibromyalgia Epidemiological studies indicate that lower sleep quality is a risk factor for fibromyalgia poor sleep is strongly and dose-dependently associated with symptom severity in the fibromyalgia population
Fatigue is widely known and understood as it is a natural response of the body to some type of physical and mental stress but it can also be a sign of some possible physical andor mental disorder patients with FM report that fatigue is characterized by excessive physical mental and cognitive tiredness and that it is usually not alleviated after hours of sleep or rest which may end up hindering the performance of work or daily tasks and thus may contribute to the adoption of sedentary behavior Fatigue is one of the main symptoms reported by patients with FM when asked about the determining factor impacting their overall health quality of life and overall perception of this syndrome Patients with FM have significantly worse levels of quality of life when compared to healthy individuals So affecting the socialization making it difficult for them to work and perform the daily tasks
Cardiorespiratory fitness evaluation should be considered by general and respiratory physicians as well as physiotherapists who treat patients diagnosed with fibromyalgia for more accurate diagnosis exercise prescription and monitoring of patients status Heart rate variability biofeedback is a self-management strategy that guides individuals to breathe at a designated resonance frequency of the cardiovascular system Resonant breathing may reduce FM-related symptoms as well as improve physical functioning and quality of life Heart rate variability biofeedback for chronic pain we found no studies testing the feasibility for individuals with FM regarding protocol adherence or acceptability of the treatment
Current clinical guidelines for the management of patients with FM recommended multimodal conservative treatments to improve the pain-related symptoms the physical function and the quality of life Among the conservative treatments clinical guidelines include non-pharmacological therapies such as exercise therapy mind-body therapies patient education manual therapy needling therapies balneotherapy and multimodal therapies Qigong is a mind-body exercise that is similar to tai chi and should be included in future research on mind-body exercises There is growing evidence Qigong is a modality of traditional Chinese mind-body medicine that has been used to prevent and cure ailments It is focuses on mind-body integration is thought to be an effective exercise in promoting physical and mental wellbeing Core elements of qigong practice involve movements meditative components attention to breathing and promotion of a state of deep relaxation and integration Qigong characterized as meditative movement uses a framework of movement with unique attentional features A further characterization is as movement-based embodied contemplative practice in which the mind-body connection is emphasized qualities and characteristics of movement are distinguished from conventional exercise and contemplative aspects are considered within a framework of body awareness and somatic approaches
Qigong is a total body and mind movement that coordinates body posture movement and breathing As a mind-body exercise the key elements of Qigong are body movement spiritual guidance and controlled breathing and Qigong can enhance the cardiorespiratory endurance and flexibility of college students reduce anxiety alter their state of mind and improve the psychological well-being thus promoting the development of their physical and mental health
Qigong exercise generates an oxygen supply and acid-base balance against the hypoxic effects of underlying pathological conditions We also propose that Qigong exercise mediated and focused on the local hypoxia environment of tissues might normalize the circulation of metabolic and inflammation accumulation in the tumor tissue and restore the normal metabolism of tissues and cells through calm relaxation and extreme Zen-style breathing that gravitates toward preemptive health and medicine that both tai chi and qigong reduce inflammatory markers such as C-reactive protein and interleukin-6 displaying a larger pooled effect size than meditation
Qigong may be effective to improve vital capacity it is possible to affirm that Qigong is effective in lowering resting heart rate And in addition to positive comments on core domains that essentially recapitulate the quantitative information pain sleep impact physical and mental function health benefits in other areas also are reported eg food allergies chemical sensitivities asthma sleep apnea migraines and blood pressure
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 116 and 322 for anxiety disorders
Chronic pain and poor sleep primary insomnia provoke persistent stress-immune activation Given the evidential effects on quality of life and other medical and psychiatric manifestations that chronic pain and insomnia each have and the notable pain-sleep connections an exaggerated combined effect
Poor sleep is reported by almost 80 of patients with fibromyalgia Epidemiological studies indicate that lower sleep quality is a risk factor for fibromyalgia poor sleep is strongly and dose-dependently associated with symptom severity in the fibromyalgia population
Fatigue is widely known and understood as it is a natural response of the body to some type of physical and mental stress but it can also be a sign of some possible physical andor mental disorder patients with FM report that fatigue is characterized by excessive physical mental and cognitive tiredness and that it is usually not alleviated after hours of sleep or rest which may end up hindering the performance of work or daily tasks and thus may contribute to the adoption of sedentary behavior Fatigue is one of the main symptoms reported by patients with FM when asked about the determining factor impacting their overall health quality of life and overall perception of this syndrome Patients with FM have significantly worse levels of quality of life when compared to healthy individuals So affecting the socialization making it difficult for them to work and perform the daily tasks
Cardiorespiratory fitness evaluation should be considered by general and respiratory physicians as well as physiotherapists who treat patients diagnosed with fibromyalgia for more accurate diagnosis exercise prescription and monitoring of patients status Heart rate variability biofeedback is a self-management strategy that guides individuals to breathe at a designated resonance frequency of the cardiovascular system Resonant breathing may reduce FM-related symptoms as well as improve physical functioning and quality of life Heart rate variability biofeedback for chronic pain we found no studies testing the feasibility for individuals with FM regarding protocol adherence or acceptability of the treatment
Current clinical guidelines for the management of patients with FM recommended multimodal conservative treatments to improve the pain-related symptoms the physical function and the quality of life Among the conservative treatments clinical guidelines include non-pharmacological therapies such as exercise therapy mind-body therapies patient education manual therapy needling therapies balneotherapy and multimodal therapies Qigong is a mind-body exercise that is similar to tai chi and should be included in future research on mind-body exercises There is growing evidence Qigong is a modality of traditional Chinese mind-body medicine that has been used to prevent and cure ailments It is focuses on mind-body integration is thought to be an effective exercise in promoting physical and mental wellbeing Core elements of qigong practice involve movements meditative components attention to breathing and promotion of a state of deep relaxation and integration Qigong characterized as meditative movement uses a framework of movement with unique attentional features A further characterization is as movement-based embodied contemplative practice in which the mind-body connection is emphasized qualities and characteristics of movement are distinguished from conventional exercise and contemplative aspects are considered within a framework of body awareness and somatic approaches
Qigong is a total body and mind movement that coordinates body posture movement and breathing As a mind-body exercise the key elements of Qigong are body movement spiritual guidance and controlled breathing and Qigong can enhance the cardiorespiratory endurance and flexibility of college students reduce anxiety alter their state of mind and improve the psychological well-being thus promoting the development of their physical and mental health
Qigong exercise generates an oxygen supply and acid-base balance against the hypoxic effects of underlying pathological conditions We also propose that Qigong exercise mediated and focused on the local hypoxia environment of tissues might normalize the circulation of metabolic and inflammation accumulation in the tumor tissue and restore the normal metabolism of tissues and cells through calm relaxation and extreme Zen-style breathing that gravitates toward preemptive health and medicine that both tai chi and qigong reduce inflammatory markers such as C-reactive protein and interleukin-6 displaying a larger pooled effect size than meditation
Qigong may be effective to improve vital capacity it is possible to affirm that Qigong is effective in lowering resting heart rate And in addition to positive comments on core domains that essentially recapitulate the quantitative information pain sleep impact physical and mental function health benefits in other areas also are reported eg food allergies chemical sensitivities asthma sleep apnea migraines and blood pressure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None