UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020947 |
|---|---|
| Receipt number | R000024173 |
| Scientific Title | The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases. |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2019/02/12 10:00:24 |
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Basic information
Public title
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Acronym
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Scientific Title
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Scientific Title:Acronym
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Region
| Japan |
Condition
Condition
hemophilia
Classification by specialty
| Hematology and clinical oncology | Infectious disease | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate the effect of rehabilitation on an outpatient basis in HIV-infected middle-aged and elderly hemophilia hemophilia cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
initial point,after six months exercise,after one year exercise:range of motion, muscular strength, grip strength, limbs lap diameter, 10m walking speed
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
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After the initial evaluation at the outpatient, carried out rehabilitation in six months outpatient, then performs a mid-term evaluation at the foreign, perform a self-exercise in followed by six months home. We make a final evaluation at the outpatient after the end.
Interventions/Control_2
After the initial evaluation at the outpatient, conducted a self-exercise in six months at home, and then performs a mid-term evaluation at the outpatient, perform the rehabilitation in followed by six months of outpatient. We make a final evaluation at the outpatient after the end.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case hoping for participation in the fitness test and agree to the study use of the result of range of motion, manual muscle test, a grip strength, and the 10m walking test(but the 10m walk test is not required.)
Key exclusion criteria
A case with not healing hemorrhagic arthropathy.
A case with joint bleeds.
A case with intramuscular bleeding.
A case with the fracture.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiharu Komachi |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-21-1 toyama shinzyuku-ku, Tokyo
TEL
03-3202-7181
tkomachi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Fujitani |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-21-1 toyama shinzyuku-ku, Tokyo
TEL
0332027181
Homepage URL
jufujita@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for AIDS Prevention
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
no
Name of secondary funder(s)
no
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
国立国際医療研究センター（National Center for Global Health and Medicine）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 09 | 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
There was no significant improvement in the range of motion in both outpatient physical therapy and home-exercise.Both outpatient physical therapy and home-exercise significantly improved muscular strength around the hip joint.
Outpatient physical therapy significantly improved walking speed and cadence of fast walking rather than home-exercise alone.
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
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
How to recruit participants in the study, recruit through the posting on the outpatient of Aids Clinical Center and hemophilia patients' association.
Management information
Registered date
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024173
