UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000030051
Receipt No. R000034312
Scientific Title Effect of recumbent yoga on patients with CFS
Date of disclosure of the study information 2017/11/20
Last modified on 2020/05/23 (Ver. 6)

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Basic information
Public title Effect of recumbent yoga on patients with CFS
Acronym Recumbent yoga for CFS
Scientific Title Effect of recumbent yoga on patients with CFS
Scientific Title:Acronym Recumbent yoga for CFS
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the effect of recumbent isometric yoga on severe patients with chronic fatigue syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Before and after intervention period (12 weeks)
severity of fatigue
1) Chalder's fatigue scale score
2) POMS F score
Key secondary outcomes Blood biomarkers such as DHEA-S, IFNg, IL-6 etc, autonomic nervous function, surface body temperature, fMRI.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 standard pharmacotherapy
Interventions/Control_2 pharmacotherapy + 20 min/day, daily recumbent isometric yoga
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 Subjects were outpatients with CFS who visited the Department of Psychosomatic Medicine, International University of Health and Welfare Hospital who didn't recover satisfactory in spite of the treatments for at least 6 months.
Key exclusion criteria Patients were excluded if their fatigue was due to physical disease such as liver, kidney, heart, respiratory, endocrine, autoimmune, or malignant disease, severe anemia, electrolyte abnormalities, obesity, or pregnancy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takakazu
Middle name
Last name Oka
Organization International University of Health and Welfare Hospital
Division name Psychosomatic Medicine
Zip code 329-2763
Address Iguchi 537-3, Basushiobara-shi, Tochi-gi
TEL 0287-39-3060
Email okatakakazu@gmail.com

Public contact
Name of contact person
1st name Takakazu
Middle name
Last name Oka
Organization International University of Health and Welfare Hospital
Division name Psychosomatic Medicine
Zip code 329-2763
Address Iguchi 537-3, Basushiobara-shi, Tochi-gi
TEL 0287-39-3060
Homepage URL
Email okatakakazu@gmail.com

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization International University of Health and Welfare
Address Nasushiobara, Tochigi
Tel 0287-39-3060
Email masa-takahashi@iuhw.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 20 Day

Related information
URL releasing protocol n.a.
Publication of results Unpublished

Result
URL related to results and publications not published yet
Number of participants that the trial has enrolled 48
Results 
Patients with CFS who were refractory to treatments as usual  (TAU) were divided into recumbent isometric yoga group (TAU and recumbent isometric yoga, n=24) or control group (TAU only, n=24). The Chalder fatigue scale (FS) scores of the two groups were compared before and after the 3 - month intervention period. The FS score of the recumbent isometric yoga group decreased significantly compared with the control group.
Results date posted
2020 Year 05 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
CFS patients (20-70 years old, regardless of gender) who visited our department
Participant flow 
CFS patients who visit our outpatient department are randomly divided into two groups, one group that continues regular treatment (normal treatment group) and the other group that uses yoga for regular treatment (yoga combination group), and randomized comparison for 24 weeks Conduct the test. However, patients in the yoga group will learn yoga directly from the yoga teacher at outpatient visits every 2 to 4 weeks, and on other days, they will study yoga by watching You Tube at home.
Adverse events 
None
Outcome measures 
Chalder fatigue scale score.
performance status,
SF8, Hospital anxiety and depression scale (HADS), Profile of mood states (POMS)
Autonomic nerve function test, body surface temperature,
Blood biomarkers (DHEA-S, acylcarnitine, IFNg, IL6, TGFb1, BDNF, etc.)
Brain image (fMRI),
Dosage and adverse events,
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
2017 Year 09 Month 07 Day
Anticipated trial start date
2017 Year 09 Month 07 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2020 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034312