UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of High- and Low-velocity Resistance Training on Gait Kinematics and Kinetics in Individuals with Hip Osteoarthritis
Title of the study (Brief title)	High- and Low-velocity Resistance Training for Hip Osteoarthritis
Region	Japan

Condition
Condition	Hip Osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of high- and low-velocity resistance training on gait kinematics and kinetics in patients with hip osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Joint angle, joint moment during gait (Parameters are assessed at baseline and 8 weeks after intervention)
Key secondary outcomes	Walking speed, cadence, stride length, muscle strength, muscle power, pain, Harris Hip Score, Timed Up and Go test, 3 minutes walking distance (Parameters are assessed at baseline and 8 weeks after intervention)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Eight-week daily home-based resistance training at high-velocity consisting of hip abduction, extension and flexion and knee extension
Interventions/Control_2	Eight-week daily home-based resistance training at low-velocity consisting of hip abduction, extension and flexion and knee extension
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who diagnosed with hip osteoarthritis Ability to live community and to walk independently
Key exclusion criteria	Patients after total hip arthroplasty Patients with a neurological disorder Patients with a cardiovascular disease Patients with knee, ankle, or back symptoms that limited their function Patients who cannot walk 6m without assistive device Patients who received prior physical therapy or other physical activity program
Target sample size	64

Research contact person
Name of lead principal investigator	Noriaki Ichihashi
Organization	Kyoto University
Division name	Human Health Sciences, Graduate School of Medicine
Address	53,Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL	075-751-3935
Email	ichihashi.noriaki.5z@kyoto-u.ac.jp

Public contact
Name of contact person	Yoshirhiro Fukumoto
Organization	Kobe Gakuin University
Division name	Faculty of Rehabilitation
Address	518, Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180 Japan
TEL	078-974-2461
Homepage URL
Email	fukumoto@reha.kobegakuin.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 30 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 21 Day
Last modified on	2016 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025290