Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes

NCT ID: NCT03496961

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Chronic Fatigue Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Yan Nian Jiu Zhuan Fa

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.

Group Type EXPERIMENTAL

Yan Nian Jiu Zhuan Fa

Intervention Type BEHAVIORAL

Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education

cognitive psychology education

Psychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.

Group Type PLACEBO_COMPARATOR

Yan Nian Jiu Zhuan Fa

Intervention Type BEHAVIORAL

Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education

blank control

this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yan Nian Jiu Zhuan Fa

Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education

Intervention Type BEHAVIORAL

Other Intervention Names

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cognitive behavior education

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Yao, Doc

Role: CONTACT

13585975106

Facility Contacts

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Fangfang Xie, postgraduate

Role: primary

18816515192

References

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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.

Reference Type RESULT
PMID: 25274261 (View on PubMed)

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.

Reference Type RESULT
PMID: 25816406 (View on PubMed)

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.

Reference Type RESULT
PMID: 19843509 (View on PubMed)

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.

Reference Type RESULT
PMID: 24634898 (View on PubMed)

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.

Reference Type RESULT
PMID: 19004564 (View on PubMed)

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.

Reference Type RESULT
PMID: 21112746 (View on PubMed)

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.

Reference Type RESULT
PMID: 22985998 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35911899 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35847786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32787361 (View on PubMed)

Other Identifiers

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81774443

Identifier Type: -

Identifier Source: org_study_id

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