NCT03496961

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 19, 2018

Last Update Submit

March 16, 2021

Conditions

Chronic Fatigue Syndromes

Keywords

Yan Nian Jiu Zhuan Fa

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (6)

  • Short Form 36-item Health Survey (SF-36)

    6 months

  • Brain functional connectivity

    6 months

  • Bristol Stool Scale

    6 months

  • Pittsburgh Sleep Quality Index

    6 months

  • Neuropeptide Y

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Yan Nian Jiu Zhuan Fa

EXPERIMENTAL

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.

Behavioral: Yan Nian Jiu Zhuan Fa

cognitive psychology education

PLACEBO COMPARATOR

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

Behavioral: Yan Nian Jiu Zhuan Fa

blank control

NO INTERVENTION

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

Interventions

Yan Nian Jiu Zhuan FaBEHAVIORAL

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

Also known as: cognitive behavior education
Yan Nian Jiu Zhuan Facognitive psychology education

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, 201203, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 25274261RESULT

  • 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.

    PMID: 25816406RESULT

  • 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.

    PMID: 19843509RESULT

  • 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.

    PMID: 24634898RESULT

  • 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.

    PMID: 19004564RESULT

  • 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.

    PMID: 21112746RESULT

  • 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.

    PMID: 22985998RESULT

  • 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.

    PMID: 35911899DERIVED

  • 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.

    PMID: 35847786DERIVED

  • 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.

    PMID: 32787361DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Fei Yao, Doc

CONTACT

13585975106doctoryaofei@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 12, 2018

Study Start

December 1, 2018

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

CN(1)