UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The musculoskeletal function survey of HIV-infected middle-aged and elderly hemophilia
Title of the study (Brief title)	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	Junko Fujitani
Organization	National Center for Global Health and Medicine
Division name	department of rehabilitation medicine
Address	1-21-1 toyama shinzyuku-ku, Tokyo
TEL	03-3202-7181
Email	jufujita@hosp.ncgm.go.jp

Public contact
Name of contact person	Junko Fujitani
Organization	National Center for Global Health and Medicine
Division name	department of rehabilitation medicine
Address	1-21-1 toyama shinzyuku-ku, Tokyo
TEL	03-3202-718
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022098