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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013475
Receipt No. R000015683
Scientific Title Development of exercise training regimen as second prevention for breast cancer survivors.
Date of disclosure of the study information 2014/03/21
Last modified on 2014/03/21

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Basic information
Public title Development of exercise training regimen as second prevention for breast cancer survivors.
Acronym Development of exercise training regimen as second prevention for breast cancer survivors.
Scientific Title Development of exercise training regimen as second prevention for breast cancer survivors.
Scientific Title:Acronym Development of exercise training regimen as second prevention for breast cancer survivors.
Region
Japan

Condition
Condition postmenopausal women with breast cancer
Classification by specialty
Breast surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To investigate of effect of high intensity interval walking for physical function, psychosocial function and risk factor of breast cancer recurrence on breast cancer survivor.

2. To investigate of most suitable training regimen in the breast cancer patient which compare the effect of normal walking training and high intensity walking training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes cardiopulmonary fitness
Body weight
Body fat
Key secondary outcomes muscle strength
health-related quality of life
serum lipid
glucose
sex hormone
Adipo-cytokine
proinflammatory cytokine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 To walk more than 8000 steps per day at approximately 50% VO2peak for walking for a minimum of 4 days per week.
Interventions/Control_2 To repeat the following regimen 4 or more times per week: 5 or more sets of 2 to 3 minute low-intensity walking intervals (at approximately 40% VO2peak
), followed by a 3-minute interval of high-intensity walking (>70% but <85% VO2peak).
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
40 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Post menopausal women with breast cancer
Stage 1-3a
Completed adjuvant treatment (with the exception of hormonal therapy) at least 6 months
Key exclusion criteria Stage 4
Cardiopulmonary disease
Neurologic disease
Cognitive disease
Target sample size 94

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Morishima
Organization Hamamatsu university school of medicine
Division name Department of rehabilitation
Zip code
Address 1-20-1, Handa-yama, Higashi-ku Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2746
Email yutakapt@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Morishima
Organization Hamamatsu university school of medicine
Division name Department of rehabilitation
Zip code
Address 1-20-1, Handa-yama, Higashi-ku Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2746
Homepage URL
Email yutakapt@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization Japan society for the promotion science
Organization
Division
Category of Funding Organization
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
2014 Year 03 Month 21 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
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 12 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 21 Day
Last modified on
2014 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015683

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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