UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019114 |
|---|---|
| Receipt number | R000022098 |
| Scientific Title | The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/10/09 10:04:14 |
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Basic information
Public title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia
Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia
Scientific Title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia
Scientific Title:Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia
Region
| Japan |
Condition
Condition
hemophilia
Classification by specialty
| Hematology and clinical oncology | Infectious disease | Orthopedics |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to survey the motor function of HIV-infected hemophilia by cross-sectional and longitudinal compares.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to survey the musculoskeletal disorders of HIV-infected the middle-aged and elderly hemophilia. It performs a musculoskeletal screening at the time of hemophilia patient advocacy, and the cross-cutting assessment of motor function. By continuing this survey three years, to survey the longitudinal assessment of the motor function.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
range of motion, muscular strength, grip strength, limbs lap diameter, 10m walking speed
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 | 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
03-3202-7181
jufujita@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
03-3202-718
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
Japanese Governmental office
Nationality of Funding Organization
Japan
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
国立国際医療研究センター（東京都）(National Center for Global Health and Medicine)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
*MMT: Muscle weakness was recognized from the age of 40. The most notable muscle weakness was the muscular strength of the hip abductor abutment, then the muscle weakness of the elbow joint extension was stronger. In the range of joint movement, reduction of the elbow joint and extension for the upper limbs and decrease of hip joint abduction and extension for the lower limb were remarkable.
*Walking speed: The walking speed was compared by age. As a result, as the age increased, the speed and stride had decreased. The walking speed was faster than last year. This is due to the existence of new participants who are young and fast walking speed and the improvement of the walking speed of aged participants. Many cases have improved walking speed. This suggests that the participation of the exerciser examinations themselves has led to motivation to maintain motor function and resulted in improvement.
*ROM: Overall, extention of the elbow joint was most restricted, then restraint of the dorsi joint of the ankle was prominent. The range of joint motion by age was remarkable over time in flexion of the knee joint and bending of the elbow joint. The range of motion by age was remarkable over time in flexion of the knee joint and flexion of the elbow joint.
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 | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 31 | 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 | 11 | Day |
Other
Other related information
study design:cohort
recruitment:Hemophilia Patients' association "Habataki" holds a Gathering of patients every year. At that time, they perform a kind of Measurement event of motor function by our cooperation. In the participants, those who agree to use their data are the subjects of our study. Our study is continued for three years.
Management information
Registered date
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022098
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
