UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022017 |
|---|---|
| Receipt number | R000025290 |
| Scientific Title | Effects of High- and Low-velocity Resistance Training on Gait Kinematics and Kinetics in Individuals with Hip Osteoarthritis |
| Date of disclosure of the study information | 2016/04/22 |
| Last modified on | 2016/04/21 18:43:47 |
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Basic information
Public title
Effects of High- and Low-velocity Resistance Training on Gait Kinematics and Kinetics in Individuals with Hip Osteoarthritis
Acronym
High- and Low-velocity Resistance Training for Hip Osteoarthritis
Scientific Title
Effects of High- and Low-velocity Resistance Training on Gait Kinematics and Kinetics in Individuals with Hip Osteoarthritis
Scientific Title:Acronym
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)
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
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
| 1st name | |
| Middle name | |
| Last name | Noriaki Ichihashi |
Organization
Kyoto University
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
Address
53,Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL
075-751-3935
ichihashi.noriaki.5z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshirhiro Fukumoto |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
Address
518, Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180 Japan
TEL
078-974-2461
Homepage URL
fukumoto@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025290
