UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016333 |
|---|---|
| Receipt number | R000018952 |
| Scientific Title | Effect of branched chain amino acid with muscle strength exercise on patients with hip osteoarthritis: Confirmatory study |
| Date of disclosure of the study information | 2015/01/25 |
| Last modified on | 2020/07/13 09:08:20 |
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Basic information
Public title
Effect of branched chain amino acid with muscle strength exercise on patients with hip osteoarthritis: Confirmatory study
Acronym
Effect of branched chain amino acid with muscle strength exercise on patients with hip osteoarthritis
Scientific Title
Effect of branched chain amino acid with muscle strength exercise on patients with hip osteoarthritis: Confirmatory study
Scientific Title:Acronym
Effect of branched chain amino acid with muscle strength exercise on patients with hip osteoarthritis
Region
| Japan |
Condition
Condition
Hip osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using randomized control trial, This study examined the efficacy of muscle strength exercise combined with branched chain amino acid supplementation to physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Hip abductor strength
Key secondary outcomes
Physical activity
(Frenchay activities index)
Grip strength
10-m timed gait test
JHEQ mental status score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Branched amino acid supplement
6g/ 1 month
Interventions/Control_2
starch 1.2g/ 1 month
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients scheduled for mini incision total hip arthroplasty.
2) Patients with no deglutition disorder.
3) Patients with osteoarthritis
4) Patients with bilateral osteoarthritis who were operated contralateral side THA
Key exclusion criteria
1) Persons with past surgical history
2) Persons with renal disorder who need to dietary restriction
3) Persons with progressive disorder of the nervous system and muscle
4) Patients scheduled for conventional total hip arthroplasty.
5) Patients scheduled for arthroplasy with osteotomy
6) Patients scheduled for arthroplasy with hip adductor muscle dehiscence
7) Patients with dementia
8) Patients with the depression or schizophrenic disorder
9) Patients with cerebro-vascular disease
10) Patients with untreated cardio
-vascular disorder
11) Patients with pregnant
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical and Dental University Graduate school
Division name
Department of Rehabilitation Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
+81-03-5803-5648
tikeda-tmd@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical and Dental University Graduate school
Division name
Department of Rehabilitation Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, 113-8510 Tokyo, Japan
TEL
+81-03-5803-5648
Homepage URL
tikeda-tmd@umin.ac.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Tokushukai Group Ethical Committee
Address
1-8-7,Koji-machi,Chiyoda-ku,Tokyo 102-0083,Japan
Tel
+81-03-3263-4801
hisamatsu@mirai-iryo.com
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
湘南鎌倉人工関節センター（神奈川）
Shonan Kamakura Joint Reconstruction Center (Kanagawa, Japan)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1142/S1013702518500038
Number of participants that the trial has enrolled
43
Results
There was a marginally significant difference in the main effect between the groups in 10-m timed gait time. The improvement rate in hip abductor muscle strength of the contralateral side was significantly greater in the BCAA group.
Results date posted
| 2020 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
The eligible patients were 55 women with secondary
hip OA scheduled for primary unilateral total
hip arthroplasty (THA) with a delay of 1.5
months.
Participant flow
A one-month period of supplementation
was combined with exercise.
Adverse events
none
Outcome measures
Demographic data were collected from clinicalrecords and included age, body mass index (BMI),intervention
and prescribed analgesic medicine. Evaluations were conducted in the pre-intervention period and the post-intervention period.
Investigators assessed muscle strength and the 10-m timed gait test before and after the intervention. The Frenchay Activities Index (FAI) and the Japanese Orthopedic Association Hip-Disease Evaluation Questionnaire (JHEQ) were evaluated before the intervention. The compliance rate with home exercise was measured after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 25 | Day |
Last modified on
| 2020 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018952
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