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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009646
Receipt No. R000011315
Scientific Title Effect of yoga therapy on chronic fatigue syndrome
Date of disclosure of the study information 2012/12/28
Last modified on 2018/02/28

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Basic information
Public title Effect of yoga therapy on chronic fatigue syndrome
Acronym Yoga for chronic fatigue syndrome
Scientific Title Effect of yoga therapy on chronic fatigue syndrome
Scientific Title:Acronym Yoga for chronic fatigue syndrome
Region
Japan

Condition
Condition chronic fatigue syndrome
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study safety and efficacy of yoga on chronic fatigue syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Severity of fatigue
Key secondary outcomes Other physical and psychological symptoms, autonomic functions, adverse reactions, and dosage of medication.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Conventional therapy and yoga group
Interventions/Control_2 Conventional therapy group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Those who satisfy the diagnostic criteria of CFS (by the Ministry of Health, Labour and Welfare).
2) Those whose ages are between 20 and 70.
3) Those whose performance status is between 3 and 7.
4) Those who can fill in questionnaires.
5) Those who can practice yoga for 20 min.
Key exclusion criteria Those whose fatigue is assumed to be caused by other physical diseases or pregnancy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Sudo
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Psychosomatic Medicine
Zip code
Address Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL 812-8582
Email nobuyuki@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takakazu Oka
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Psychosomatic Medicine
Zip code
Address Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL 812-8582
Homepage URL
Email oka-t@cephal.med.kyushu-u.ac.jp

Sponsor
Institute Department of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu Uninversity,
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 576
Org. issuing International ID_1 Kyushu University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院(福岡)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This trial demonstrated that isometric yoga together with conventional therapy was more effective in relieving fatigue than was conventional therapy alone in patients with CFS.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 28 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 27 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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