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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026836
Receipt No. 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 2019/02/07

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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
Middle name
Last name Junko Fujitani
Organization National Center for Global Health and Medicine
Division name department of rehabilitaition medicine
Zip code
Address 1-21-1 toyama shinzyuku-ku,Tokyo
TEL 03-3202-7181
Email 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 rehabilitaition medicine
Zip code
Address 1-21-1 toyama shinzyuku-ku,Tokyo
TEL 03-3202-7181
Homepage URL
Email jufujita@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email

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
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
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
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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