UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034385 |
|---|---|
| Receipt number | R000039201 |
| Scientific Title | On the effect of triceps training at home in elderly women with medial knee osteoarthritis |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/04/07 23:27:00 |
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Basic information
Public title
On the effect of triceps training at home in elderly women with medial knee osteoarthritis
Acronym
On the effect of triceps training at home in elderly women with medial knee osteoarthritis
Scientific Title
On the effect of triceps training at home in elderly women with medial knee osteoarthritis
Scientific Title:Acronym
On the effect of triceps training at home in elderly women with medial knee osteoarthritis
Region
| Japan |
Condition
Condition
Medial knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the training effect of the triceps muscle in medial knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
External knee adduction moment
Key secondary outcomes
1.10m walking test
2.Manual muscle force measurement by hand held dynamometer
3.Japanease Knee Osteoarthritis Measure:JKOM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
8 weeks lower leg triceps muscle strengthening(10*5sets per days,three times a week).
Interventions/Control_2
8 weeks quadriceps muscle strengthening(10*5sets per days,three times a week).
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Women 65 to 85 years old
2.Those diagnosed as varico-osteoarthritic
osteoarthritis from doctors
Key exclusion criteria
1.Person who has a history of central nervous system disease
2.Those who have a history of artificial joint replacement in the lower limb joint
3.Persons who have a history of trauma or surgery on the lower limbs
4.Those who have a history of serious heart disease or lung disease
5.Person who is using cane etc in everyday life and can not walk alone
6.Those who can not properly understand the operation instructions or who can not properly perform the action
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | akira |
| Middle name | |
| Last name | Kanai |
Organization
Toyohashi Sozo University graduate school
Division name
School of Health Sciences
Zip code
440-0016
Address
Aichi Prefecture Toyohashi City Usukawa Town Matsushita 20-1
TEL
050-2017-2276
kanai@sozo.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Motoyama |
Organization
Toyohashi Sozo University graduate school
Division name
School of Health Sciences
Zip code
441-8061
Address
Aichi Prefecture Toyohashi City Usukawa Town Matsushita 20-1
TEL
090-1825-2803
Homepage URL
s1655103@sc.sozo.ac.jp
Sponsor or person
Institute
Toyohashi Sozo University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Sozo University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyohashi sozo University Research Ethics Review Committee
Address
Aichi Prefecture Toyohashi City Usukawa Town Matsushita 20-1
Tel
0532-54-2111
yass@sozo.ac.jp
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
かんべ整形リハビリクリニック(愛知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | 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
10
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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039201
| Research Plan | |
|---|---|
| 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 |
