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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007420
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Graduate school of sports science, Waseda University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008740

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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