UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000016333 |
| Receipt No. | 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 (Ver. 9) |
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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 |
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| Condition | |||
| Condition | Hip osteoarthritis | ||
| 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 |
| 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 |
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| Interventions/Control_1 | Branched amino acid supplement
6g/ 1 month |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 56 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Shonan Kamakura Joint Reconstruction Center |
| Institute | |
| Department | |
| 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 |
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| 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. |
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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 55 women with secondary hip OA scheduled for primary unilateral total hip arthroplasty (THA) with a delay of 1.5 months. |
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| Participant flow | A one-month period of supplementation was combined with exercise. |
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| Adverse events | none |
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| 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. |
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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=R000018952 |
