UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006656 |
|---|---|
| Receipt number | 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 13:11:18 |
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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
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
Sponsor or person
Institute
Graduate School of Biomedical & Health Sciences, Hiroshima University
Psychosocial Rehabilitation Laboratory
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006814
