Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes (YNJZFCFS)
Primary Purpose
Chronic Fatigue Syndromes
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yan Nian Jiu Zhuan Fa
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndromes focused on measuring Yan Nian Jiu Zhuan Fa
Eligibility Criteria
Inclusion criteria:
The occurrence of four or more of the following symptoms:
- Subjective memory impairment
- Tender lymph nodes
- Muscle pain
- Joint pain
- Headache
- Unrefreshing sleep
- Post-exertion malaise lasting for more than 24 hours
Exclusion criteria:
- Active, unresolved, or suspected medical disease
- Psychotic, melancholic or bipolar depression (but not uncomplicated major depression)
- Psychotic disorders
- Dementia
- Anorexia or bulimia nervosa
- Alcohol or other substance misuse
- Severe obesity.
Sites / Locations
- Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Yan Nian Jiu Zhuan Fa
cognitive psychology education
blank control
Arm Description
The kneading process will be done under the therapist guidance for 30 minutes with an average pressure of 5 Newton each time for 3 times every day.
Psychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.
this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.
Outcomes
Primary Outcome Measures
Multidimensional Fatigue Inventory (MFI-20)
A self-report instrument consisting of 20-item devised to measure fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This instrument takes about 5 to 10 minutes to complete. The instrument's psychometric properties were tested and determined to have good internal consistency and construct validity in samples with Chronic Fatigue Syndrome (CFS).
Secondary Outcome Measures
Short Form 36-item Health Survey (SF-36)
The SF-36 is an internationally well-validated measure of Health-related quality of life that has a broad scope of questions validated across different chronic diseases and comorbidities.
Brain functional connectivity
Functional connectivity density (FCD) is a newly developed data-driven method to measure the number of functional connections of each voxel, possibly providing new insight into the neural correlates of fluid reasoning.Functional magnetic resonance imaging (fMRI) is a novel method for studying the changes of brain functional connectivity.
Bristol Stool Scale
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields. The seven types of stool are:
Scale 1: Separate hard lumps, like nuts (hard to pass), also known as goat feces or sausage-shaped, but lumpy.
Scale 2: Like a sausage but with cracks on its surface or like a sausage or snake, smooth and soft.
Scale 3: Soft blobs with clear cut edges (passed easily). Scale 4: Fluffy pieces with ragged edges, a mushy stool even watery, no solid pieces, entirely liquid.
Scale 1 indicate constipation, Scale 2 being the ideal stools as they are easy to defecate while not containing excess liquid, Scale 3 tending towards diarrhea, and Scale 4 indicate diarrhea.
Pittsburgh Sleep Quality Index
A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Neuropeptide Y
Neuropeptide Y (NPY) is a 36 amino-acid neuropeptide that is involved in various physiological and homeostatic processes in both the central and peripheral nervous systems. NPY has been identified as the most abundant peptide present in the mammalian central nervous system, which consists of the brain and spinal cord. It is secreted alongside other neurotransmitters such as glutamate.
Substance P
Substance P is a bioactive 11-amino acid peptide (Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-amide) first isolated in 1931 from brain and intestine. The peptide is involved in many physiological processes including pain modulation, smooth muscle contraction, blood pressure control, kidney function and water homeostasis.Substance P is widely distributed in numerous tissues and body fluids including the central and peripheral nervous system, gastrointestinal tract, respiratory tract, visual system and circulatory system.
Full Information
NCT ID
NCT03496961
First Posted
March 19, 2018
Last Updated
March 16, 2021
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Yueyang Integrated Medicine Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03496961
Brief Title
Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes
Acronym
YNJZFCFS
Official Title
Shanghai University of Traditional Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Yueyang Integrated Medicine Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to disclose the mechanism of characteristic Tao yin exercises regulate Chronic Fatigue Syndromes based on Brain-Gut Axis.Explore the clinical manifestation of Chronic Fatigue Syndromes, changes of neurotransmitter and central brain function. Then provide some new methods of treating Chronic Fatigue Syndromes.
Detailed Description
This research will be conducted in Shanghai University of Traditional Chinese Medicine.Then the clinical efficacy of Yan Nian Jiu Zhuan Fa on Chronic Fatigue Syndrome will be observed by examining gastrointestinal function, affecting the content of substances in plasma and analysing the central nerve response mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndromes
Keywords
Yan Nian Jiu Zhuan Fa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinically evaluated, medically unexplained fatigue of at least 6 months duration:
Of new onset. Not a result of ongoing exertion. Not substantially alleviated rest and associated with a substantial reduction in previous levels of activity
Masking
ParticipantOutcomes Assessor
Masking Description
This will use simple randomization ways. Sofware20.0 will used to generate a random unique number for each integral number from 1 to 90 and divide the 90 numbers (1 to 90) into three groups with a ratio of 1:1:1 based on the random numbers group. The number grouping is unknown. This will be a double blind trial.
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yan Nian Jiu Zhuan Fa
Arm Type
Experimental
Arm Description
The kneading process will be done under the therapist guidance for 30 minutes with an average pressure of 5 Newton each time for 3 times every day.
Arm Title
cognitive psychology education
Arm Type
Placebo Comparator
Arm Description
Psychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.
Arm Title
blank control
Arm Type
No Intervention
Arm Description
this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.
Intervention Type
Behavioral
Intervention Name(s)
Yan Nian Jiu Zhuan Fa
Other Intervention Name(s)
cognitive behavior education
Intervention Description
Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education
Primary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory (MFI-20)
Description
A self-report instrument consisting of 20-item devised to measure fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This instrument takes about 5 to 10 minutes to complete. The instrument's psychometric properties were tested and determined to have good internal consistency and construct validity in samples with Chronic Fatigue Syndrome (CFS).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Short Form 36-item Health Survey (SF-36)
Description
The SF-36 is an internationally well-validated measure of Health-related quality of life that has a broad scope of questions validated across different chronic diseases and comorbidities.
Time Frame
6 months
Title
Brain functional connectivity
Description
Functional connectivity density (FCD) is a newly developed data-driven method to measure the number of functional connections of each voxel, possibly providing new insight into the neural correlates of fluid reasoning.Functional magnetic resonance imaging (fMRI) is a novel method for studying the changes of brain functional connectivity.
Time Frame
6 months
Title
Bristol Stool Scale
Description
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields. The seven types of stool are:
Scale 1: Separate hard lumps, like nuts (hard to pass), also known as goat feces or sausage-shaped, but lumpy.
Scale 2: Like a sausage but with cracks on its surface or like a sausage or snake, smooth and soft.
Scale 3: Soft blobs with clear cut edges (passed easily). Scale 4: Fluffy pieces with ragged edges, a mushy stool even watery, no solid pieces, entirely liquid.
Scale 1 indicate constipation, Scale 2 being the ideal stools as they are easy to defecate while not containing excess liquid, Scale 3 tending towards diarrhea, and Scale 4 indicate diarrhea.
Time Frame
6 months
Title
Pittsburgh Sleep Quality Index
Description
A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Time Frame
6 months
Title
Neuropeptide Y
Description
Neuropeptide Y (NPY) is a 36 amino-acid neuropeptide that is involved in various physiological and homeostatic processes in both the central and peripheral nervous systems. NPY has been identified as the most abundant peptide present in the mammalian central nervous system, which consists of the brain and spinal cord. It is secreted alongside other neurotransmitters such as glutamate.
Time Frame
6 months
Title
Substance P
Description
Substance P is a bioactive 11-amino acid peptide (Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-amide) first isolated in 1931 from brain and intestine. The peptide is involved in many physiological processes including pain modulation, smooth muscle contraction, blood pressure control, kidney function and water homeostasis.Substance P is widely distributed in numerous tissues and body fluids including the central and peripheral nervous system, gastrointestinal tract, respiratory tract, visual system and circulatory system.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
The occurrence of four or more of the following symptoms:
Subjective memory impairment
Tender lymph nodes
Muscle pain
Joint pain
Headache
Unrefreshing sleep
Post-exertion malaise lasting for more than 24 hours
Exclusion criteria:
Active, unresolved, or suspected medical disease
Psychotic, melancholic or bipolar depression (but not uncomplicated major depression)
Psychotic disorders
Dementia
Anorexia or bulimia nervosa
Alcohol or other substance misuse
Severe obesity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Yao, Doc
Phone
13585975106
Email
doctoryaofei@126.com
Facility Information:
Facility Name
Shanghai University of Traditional Chinese Medicine
City
Shanghai
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangfang Xie, postgraduate
Phone
18816515192
Email
1780402990@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25274261
Citation
Bakken IJ, Tveito K, Gunnes N, Ghaderi S, Stoltenberg C, Trogstad L, Haberg SE, Magnus P. Two age peaks in the incidence of chronic fatigue syndrome/myalgic encephalomyelitis: a population-based registry study from Norway 2008-2012. BMC Med. 2014 Oct 1;12:167. doi: 10.1186/s12916-014-0167-5.
Results Reference
result
PubMed Identifier
25816406
Citation
Capelli E, Lorusso L, Ghitti M, Venturini L, Cusa C, Ricevuti G. Chronic fatigue syndrome: Features of a population of patients from northern Italy. Int J Immunopathol Pharmacol. 2015 Mar;28(1):53-9. doi: 10.1177/0394632015572074.
Results Reference
result
PubMed Identifier
19843509
Citation
May M, Emond A, Crawley E. Phenotypes of chronic fatigue syndrome in children and young people. Arch Dis Child. 2010 Apr;95(4):245-9. doi: 10.1136/adc.2009.158162. Epub 2009 Oct 19.
Results Reference
result
PubMed Identifier
24634898
Citation
Porter N, Lerch A, Jason LA, Sorenson M, Fletcher MA, Herrington J. A Comparison of Immune Functionality in Viral versus Non-Viral CFS Subtypes. J Behav Neurosci Res. 2010 Jun 1;8(2):1-8.
Results Reference
result
PubMed Identifier
19004564
Citation
Exley C, Swarbrick L, Gherardi RK, Authier FJ. A role for the body burden of aluminium in vaccine-associated macrophagic myofasciitis and chronic fatigue syndrome. Med Hypotheses. 2009 Feb;72(2):135-9. doi: 10.1016/j.mehy.2008.09.040. Epub 2008 Nov 11.
Results Reference
result
PubMed Identifier
21112746
Citation
Pardini M, Guida S, Primavera A, Krueger F, Cocito L, Gialloreti LE. Amisulpride vs. fluoxetine treatment of chronic fatigue syndrome: a pilot study. Eur Neuropsychopharmacol. 2011 Mar;21(3):282-6. doi: 10.1016/j.euroneuro.2010.10.008. Epub 2010 Nov 26.
Results Reference
result
PubMed Identifier
22985998
Citation
Lloyd S, Chalder T, Rimes KA. Family-focused cognitive behaviour therapy versus psycho-education for adolescents with chronic fatigue syndrome: long-term follow-up of an RCT. Behav Res Ther. 2012 Nov;50(11):719-25. doi: 10.1016/j.brat.2012.08.005. Epub 2012 Aug 31.
Results Reference
result
PubMed Identifier
35911899
Citation
Xie F, Guan C, Gu Y, You Y, Yao F. Effects of the Prolong Life With Nine Turn Method (Yan Nian Jiu Zhuan) Qigong on Brain Functional Changes in Patients With Chronic Fatigue Syndrome in Terms of Fatigue and Quality of Life. Front Neurol. 2022 Jul 13;13:866424. doi: 10.3389/fneur.2022.866424. eCollection 2022.
Results Reference
derived
PubMed Identifier
35847786
Citation
Xie F, You Y, Guan C, Xu J, Yao F. The Qigong of Prolong Life With Nine Turn Method Relieve Fatigue, Sleep, Anxiety and Depression in Patients With Chronic Fatigue Syndrome: A Randomized Controlled Clinical Study. Front Med (Lausanne). 2022 Jun 30;9:828414. doi: 10.3389/fmed.2022.828414. eCollection 2022.
Results Reference
derived
PubMed Identifier
32787361
Citation
Xie F, Guan C, Cheng Z, Yao F, You Y. Effects of the prolong life with nine turn method (Yan Nian Jiu Zhuan) Qigong on patients with chronic fatigue syndrome: study protocol for a randomized controlled trial. Ann Palliat Med. 2020 Sep;9(5):3571-3583. doi: 10.21037/apm-19-461. Epub 2020 Aug 4.
Results Reference
derived
Learn more about this trial
Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes
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