UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of yoga therapy on chronic fatigue syndrome
Title of the study (Brief title)	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	Nobuyuki Sudo
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Psychosomatic Medicine
Address	Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL	812-8582
Email	nobuyuki@med.kyushu-u.ac.jp

Public contact
Name of contact person	Takakazu Oka
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Psychosomatic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000011315