UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026151 |
|---|---|
| Receipt number | R000030047 |
| Scientific Title | Effect of branched chain amino acid with exercise on elderly patients with total hip arthroplasty and THA revision: Confirmatory study |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2020/07/13 09:21:51 |
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Basic information
Public title
Effect of branched chain amino acid with exercise on elderly patients with total hip arthroplasty and THA revision: Confirmatory study
Acronym
Effect of branched chain amino acid with exercise on patients with total hip arthroplasty and THA revision
Scientific Title
Effect of branched chain amino acid with exercise on elderly patients with total hip arthroplasty and THA revision: Confirmatory study
Scientific Title:Acronym
Effect of branched chain amino acid with exercise on patients with total hip arthroplasty and THA revision
Region
| Japan |
Condition
Condition
Total hip arthroplasty
Revision for Total hip arthroplasty
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
knee extensor strength
muscle mass of upper and lower limb
Grip strength
Cross-sectional aera of the brachium
Functional Indepndence Measure
10-m timed gait test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
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
3.4g(6.8g)/ 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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with no deglutition disorder.
Key exclusion criteria
1) Persons with past surgical history
2) Persons with renal disorder who need
to protein 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
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Showa University
Division name
School of Nrsing and Rehabilitation sciences
Zip code
227-8517
Address
2-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
TEL
+81-045-974-2221
tk.ikeda@nr.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ikeda |
Organization
Showa University
Division name
School of Nrsing and Rehabilitation sciences
Zip code
227-8517
Address
2-1-1, Fujigaoka Aoba YOKOHAMA, KANAGAWA
TEL
+81-045-974-2221
Homepage URL
tk.ikeda@nr.showa-u.ac.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University, School of Nrsing and Rehabilitation sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Fujigaoka hospital ethic commttiee
Address
2-1-1 Fujigaoka, Aoba ward
Tel
045-974-6329
f-irb@cmed.showa-u.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
昭和大学藤が丘リハビリテーション病院: Showa University Fujigaoka Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31826368
Number of participants that the trial has enrolled
31
Results
BCAA supplementation combined with muscle strengthening exercises had a significant effect on knee extension strength of the contralateral side and on upper arm cross-sectional area. The improvement ratio of knee extension strength before and after intervention on the operated side was also significantly higher 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
| 2019 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
The eligible patients were 31 elderly women who were admitted to a ward for rehabilitation during convalescence after THA and revisions.
Participant flow
A one-month period of supplementation was
combined with physical exercises.
Adverse events
none
Outcome measures
Demographic data were collected from clinical records and included age, body mass index (BMI), co-morbidity index, diagnosis, surgical procedure, duration of hospital stay, the number of combined therapy sessions, nutritional status, and prescribed analgesic medicines. The antiinflammatory activity of non-steroidal anti-inflammatory drugs (NSAIDs) has been reported to impair satellite cell activity, which is required for muscle protein synthesis. Evaluations were conducted in the preintervention period and the post-intervention period. Investigators assessed muscle strength, skeletal muscle mass, and the functional independence measure (FIM)
score.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | 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=R000030047
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