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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006656
Receipt No. R000006814
Scientific Title A Randomized Controlled Trial to Evaluate the Effectiveness of Exrcise on a Speed Feedback therapy System in Elderly cancer patients.
Date of disclosure of the study information 2011/11/02
Last modified on 2014/02/17

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Basic information
Public title A Randomized Controlled Trial to Evaluate the Effectiveness of Exrcise on a Speed Feedback therapy System in Elderly cancer patients.
Acronym Effect of Exrcise on a Speed Feedback therapy System in Elderly cancer patients
Scientific Title A Randomized Controlled Trial to Evaluate the Effectiveness of Exrcise on a Speed Feedback therapy System in Elderly cancer patients.
Scientific Title:Acronym Effect of Exrcise on a Speed Feedback therapy System in Elderly cancer patients
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hepato-biliary-pancreatic surgery Breast surgery Psychiatry
Urology Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate to effectiveness of exrcise on a Speed Feedback therapy system in elderly cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Frontal assessment battery at bedside
Key secondary outcomes Barthel Index
Instrumental activities of daily living
Hospital anxiety and depression scale
Japanese version
Cancer fatigue scale Japanese version
Functional assessment of cancer therapy-General version4 Japanese version
Borg Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Exrcise on a Speed Feedback therapy System
Interventions/Control_2 No intervention
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Within 10 years after primary diagnosis of cancer.
PS score is 0 or 1.
Be able to communicate without disturbance of consciouness.
Knouwing about diagnosis.
Key exclusion criteria Diagnosed bone metastasis.
Having undergone whole brain irradiation.
Target sample size 62

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okamura Hitoshi
Organization Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Psychosocial Rehabilitation Laboratory
Zip code
Address 1_2_3 kasumi, Minamiku, Hiroshima
TEL 082-257-5450
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miki Emi
Organization Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Psychosocial Rehabilitation Laboratory
Zip code
Address 1_2_3 kasumi, Minamiku, Hiroshima
TEL 082-257-5452
Homepage URL
Email

Sponsor
Institute Graduate School of Biomedical & Health Sciences, Hiroshima University
Psychosocial Rehabilitation Laboratory
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare,
Grants-in-aid for Scientific Research.
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1002/pon.3501/abstract
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
2011 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2012 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 02 Day
Last modified on
2014 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006814

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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