UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030051 |
|---|---|
| Receipt number | 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 13:49:50 |
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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
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
okatakakazu@gmail.com
Sponsor or person
Institute
AMED
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034312
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| Registered date | File name |
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