UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Title of the study (Brief title)	The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
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	In this study, we investigate the effect of rehabilitation on an outpatient basis in HIV-infected middle-aged and elderly hemophilia hemophilia cases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	initial point,after six months exercise,after one year exercise:range of motion, muscular strength, grip strength, limbs lap diameter, 10m walking speed
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	After the initial evaluation at the outpatient, carried out rehabilitation in six months outpatient, then performs a mid-term evaluation at the foreign, perform a self-exercise in followed by six months home. We make a final evaluation at the outpatient after the end.
Interventions/Control_2	After the initial evaluation at the outpatient, conducted a self-exercise in six months at home, and then performs a mid-term evaluation at the outpatient, perform the rehabilitation in followed by six months of outpatient. We make a final evaluation at the outpatient after the end.
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	Toshiharu Komachi
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	tkomachi@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	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	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	no
Name of secondary funｄer(s)	no

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（National Center for Global Health and Medicine）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 09 Month 25 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 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	There was no significant improvement in the range of motion in both outpatient physical therapy and home-exercise.Both outpatient physical therapy and home-exercise significantly improved muscular strength around the hip joint. Outpatient physical therapy significantly improved walking speed and cadence of fast walking rather than home-exercise alone.
Other related information	How to recruit participants in the study, recruit through the posting on the outpatient of Aids Clinical Center and hemophilia patients' association.

Management information
Registered date	2016 Year 02 Month 09 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024173