UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026836 |
|---|---|
| Receipt number | R000030802 |
| Scientific Title | The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(2018-2020) |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/04/06 09:34:03 |
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Basic information
Public title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(2018-2020)
Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(2018-2020)
Scientific Title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(2018-2020)
Scientific Title:Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(2018-2020)
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
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,ADL
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, the 10m walking test, and ADL questions and investigations(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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitaition medicine
Zip code
162-8655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
+81332027181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitaition medicine
Zip code
162-8655
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 toyama shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://kyusai.acc.go.jp/aboutus/hemophilia/ResearchReport.html
Publication of results
Published
Result
URL related to results and publications
http://kyusai.acc.go.jp/aboutus/hemophilia/ResearchReport.html
Number of participants that the trial has enrolled
35
Results
Muscle weakness has been observed since the 40s. The most significant decrease in muscle strength was hip abduction muscle strength, followed by conspicuous decline in elbow extension strength. The walking speed of the walking speed decreased as the age increased. The range of motion of the joint was most restricted by the extension of the elbow joint, followed by the restriction of the dorsiflexion of the ankle joint. The range of motion was prominent over time in knee flexion and elbow flexion
Results date posted
| 2019 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Drug damage hemophilia
Participant flow
Among those who gathered at the patient association who participated in the Habaki Welfare Corporation and called for their participation, those who had consent to participate in the study.
Adverse events
nothing
Outcome measures
ROM,MMT,grip,walking speed,ADL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | 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
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030802
| Research Plan | |
|---|---|
| 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 |
