UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000026151 |
| Receipt No. | 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 (Ver. 9) |
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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 |
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| Condition | |||
| Condition | Total hip arthroplasty
Revision for Total hip arthroplasty |
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| Classification by specialty |
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| 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
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| 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 |
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| Interventions/Control_1 | Branched amino acid supplement
3.4g(6.8g)/ 1 month |
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| Interventions/Control_2 | starch 1.2g/ 1 month | |
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
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| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| Target sample size | 55 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Showa University Fujigaoka Hospital |
| Institute | |
| Department | |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results |
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| Baseline Characteristics | The eligible patients were 31 elderly women who were admitted to a ward for rehabilitation during convalescence after THA and revisions. |
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| Participant flow | A one-month period of supplementation was combined with physical exercises. |
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| Adverse events | none |
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| 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. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date analysis concluded |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030047 |
