UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048343 |
|---|---|
| Receipt number | R000041472 |
| Scientific Title | The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(Multicenter Trials:2019-2021) |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2023/01/11 08:34:36 |
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Basic information
Public title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(Multicenter Trials:2019-2021)
Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(Multicenter Trials:2019-2021)
Scientific Title
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(Multicenter Trials:2019-2021)
Scientific Title:Acronym
The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia(Multicenter Trials:2019-2021)
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 by Multicenter Trials.
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
ADL
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
72
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 rehabilitation medicine
Zip code
162-8655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
0332027181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1
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
Hokkaido University Hospital,Sendai Medical Center,Nogoya Medical Center,Kyusyu Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1
Tel
0332027181
kenkyu-shinsa@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、北海道大学病院、仙台医療センター、名古屋医療センター、九州医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
http://kyusai.acc.go.jp/accrepo/longterm_treatment.html
Publication of results
Partially published
Result
URL related to results and publications
http://kyusai.acc.go.jp/accrepo/longterm_treatment.html
Number of participants that the trial has enrolled
92
Results
In the range of motion, muscle strength, and walking speed, a decrease was observed compared to healthy subjects of the same generation. In a survey of daily activities, 72 (80.0% of the total) were unable to perform any movement on the ADL scale. 79 of 91 (86.8%) had painful joints. Thirty percent said it was difficult to use public transportation, many of which were difficult to maintain.
Results date posted
| 2022 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hemophilia patients with HIV infection
Participant flow
Participate in a rehabilitation check-ups co-sponsored by the patient association
Adverse events
none
Outcome measures
range of motion,muscle strengh,grip strength,walking,girth measurements, ADL
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041472
