UMIN-CTR Clinical Trial

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
Email	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
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	National Center for Global Health and Medicine
Address	1-21-1 toyama shinjuku-ku, Tokyo
Tel	03-3202-7181
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030802