UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021590 |
|---|---|
| Receipt number | R000024898 |
| Scientific Title | Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/03/25 23:46:15 |
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Basic information
Public title
Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Acronym
Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Scientific Title
Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Scientific Title:Acronym
Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of physiotherapy and game equipment that focuses of physical function and psychological status in hematological malignancy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of activity,Knee extension strength,Grip strength,Timed Up and Go test,Functional Reach test,30 seconds chair stand test,Profile of Mood States Brief Form.
Evaluation time is performed before intervention starting for more than 30 minutes in the physiotherapy starting date, 1 week later and 2 weeks later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The control group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later. In addition, physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.After that,Physical therapy in combination the game equipment(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
Interventions/Control_2
The intervention group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later.In addition, Physical therapy in combination the game equipment do physiotherapy(Aerobic exercise, muscle strength training and balance practice, 20 minutes every day and Wii Fit U, 20 minutes every day) for one week.After that,physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The hematological malignancy who enforces physiotherapy
Key exclusion criteria
The person who require assistance to walk,The person who have complications to affect the gait remarkably,The person who has difficulty in self-entry of the question paper list,The person who has difficulty in instructions understanding by the language,The person that it is predicted that I cause a change and fatigue of remarkable vital signs at the time of an evaluation,The person whom a state is unstable from head to foot in
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | daiyu kobayashi |
Organization
Saitama Medical School synthesis medical center
Division name
Rehabilitation
Zip code
Address
1981, Kamoda, Kawagoe-shi, Saitama
TEL
0492283529
kobayashidaiyu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | daiyu kobayashi |
Organization
Saitama Medical School synthesis medical center
Division name
Rehabilitation
Zip code
Address
1981, Kamoda, Kawagoe-shi, Saitama
TEL
0492283529
Homepage URL
kobayashidaiyu@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical School synthesis medical center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | 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
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024898
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
