UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013475 |
|---|---|
| Receipt number | 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 07:01:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yutakapt@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015683
