UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007420 |
|---|---|
| Receipt number | R000008740 |
| Scientific Title | A pilot study of 12 week yoga intervention for Japanese breast cancer survivors. -exploring the effectiveness and mechanisms |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2013/03/04 12:22:25 |
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Basic information
Public title
A pilot study of 12 week yoga intervention
for Japanese breast cancer survivors.
-exploring the effectiveness and mechanisms
Acronym
A pilot study of 12 week yoga intervention
for Japanese breast cancer survivors.
-exploring the effectiveness and mechanisms
Scientific Title
A pilot study of 12 week yoga intervention
for Japanese breast cancer survivors.
-exploring the effectiveness and mechanisms
Scientific Title:Acronym
A pilot study of 12 week yoga intervention
for Japanese breast cancer survivors.
-exploring the effectiveness and mechanisms
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a yoga program on persistent fatigue and QOL in breast cancer survivors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Persistent fatigue, Quality of Life,
Key secondary outcomes
Amount of daily physical activity, narrative contents on daily life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
75 minutes yoga session weekly for 12weeks
Interventions/Control_2
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
Female
Key inclusion criteria
1)at least 3 months after completion of local and/or adjuvant cancer therapy(with the exception of hormonal therapy)
2)no breast cancer recurrence
3)agreement w)primary physician to participate in this program
4)eligible to do exercise with own responsibility
5)able to attend the scheduled classes and measurements
Key exclusion criteria
1)no other chronic medical conditions
2)no current yoga practice (had not taken yoga classes regularly in past year)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Nakamura |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa-city, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yayoi Yamauchi |
Organization
Graduate school, Waseda University
Division name
Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa-city,Saitama
TEL
Homepage URL
Sponsor or person
Institute
Graduate school of sports science, Waseda University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A single yoga session has acute effects on moods. Yoga educes vigor from survivors within, and reduces fatigue. The strong correlation between fatiue and QOL is also found. Yoga increases survivors QOL and amount of physical activity during intervention. Also the results suggests that yoga may push survivors psychological recovery stages forward from their experiences of "object loss".
This series of studies shows the accomplishment to suggest effectiveness of yoga intervention and also its mechanisms. It gives many important suggestions and information to develop health-support programs for cancer survivors.
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 | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 04 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 01 | Day |
Last modified on
| 2013 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008740
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|---|---|
| Registered date | File name |
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| Registered date | File name |
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