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

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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 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


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

Value
https://center6.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