UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013172 |
|---|---|
| Receipt number | 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 00:55:59 |
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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
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
yutakapt@hama-med.ac.jp
Sponsor or person
Institute
Department of rehabilitation, Hamamastu university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015361
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
