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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013172
Receipt No. R000015361
Scientific Title Development of new home-baced exercise training regimen for total hip arthroplasty patients.
Date of disclosure of the study information 2014/02/16
Last modified on 2014/02/19

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Basic information
Public title Development of new home-baced exercise training regimen for total hip arthroplasty patients.
Acronym Development of new home-baced exercise training regimen for total hip arthroplasty patients.
Scientific Title Development of new home-baced exercise training regimen for total hip arthroplasty patients.
Scientific Title:Acronym Development of new home-baced exercise training regimen for total hip arthroplasty patients.
Region
Japan

Condition
Condition After total hip arthroplasty
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether interval walking training is helpful for THA patients to increase physical function and physical fitness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Lower extremity muscle strength
Physical fitness
Key secondary outcomes Body weight
Balance performance
Walking ability
Health-related quality of life
Mood
Glucose
Serum lipid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 No intervention. To maintain the same lifestyle.
Interventions/Control_2 To repeat 5 or more sets of 2- to 3-minute low-intensity walking intervals at ~40% of the pre-training WVO2peak, followed by a 3-minute interval of high-intensity walking at >70% but <85% WVO2peak, >4 days/wk, so that total fast walking time per week reached >60 min.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Total arthroplasty patients who are able to walk independently without any assistive devices.
Key exclusion criteria Without any acetabular and/or femoral prosthesis failure
Cardiopulmonary disease
Neurologic disease
Cognitive disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizushima
Organization Hamamatsu university school of medicine
Division name Rehabilitation
Zip code
Address 1-20-1, Handa-yama, Higashi-ku Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2746
Email mizusima@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Morishima
Organization Hamamatsu university school of medicine
Division name Rehabilitation
Zip code
Address 1-20-1, Handa-yama, Higashi-ku Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2746
Homepage URL
Email yutakapt@hama-med.ac.jp

Sponsor
Institute Department of rehabilitation, Hamamastu university school of medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor, and Welfare (Comprehensive Research on Aging and Health)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Sports Medical Sciences, Shinshu university graduate school of medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 16 Day
Last modified on
2014 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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