UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028715 |
|---|---|
| Receipt number | R000032834 |
| Scientific Title | Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial. |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2018/08/27 16:38:55 |
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Basic information
Public title
Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Acronym
Protein, medium-chain and -rehabilitation outcomes.
Scientific Title
Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Scientific Title:Acronym
Protein, medium-chain and -rehabilitation outcomes.
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIM
Compare between pre-treatment and 8 weeks after treatment
Key secondary outcomes
1, Muscle strength (hand grip)
2, Skeletal muscle mass(Calf circumference)
3, Walking speed
4,Nutritional status
5, Cognitive function(FAST)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1,Protein and medium-chain triglycerides-enriched milk. 200ml
Branched chain amino acid:BCAA 2830mg
medium-chain triglycerides:MCT 6.3g
2, Rehabilitation
Interventions/Control_2
1, Rehabilitation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,Hip fracture patients aged 65 or older
2,Under appropriate nutrition management
3,Patients who could walk with or without using a walking aid before hip fracture
4,Evaluated as malnutrition or at risk
Key exclusion criteria
1,Load limitation on an affected lower limb
2,Patients who have neurological findings such as lower limb paralysis
3,Patients who needed acute treatment with complication
4,Patients who are iudged unable to walk by physication
5,patients who are iudged inappropriate for the study by physication
6,Severe renal dysfunction
7,Cognitive decline
8,Severe dysphagia
9,Lower extremity edema
10,Lactose intolerance
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiko Nagaoka |
Organization
Sunrise Sakai Hospital
Division name
Nursing department
Zip code
Address
3156-1 Hiji, Hayami, Oita 879-1506
TEL
09777222266
usrknjsnsi@gmal.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Kobayashi |
Organization
Sunrise Sakai Hospital
Division name
Committee of Research, Education and Training
Zip code
Address
3156-1 Hiji, Hayami, Oita 879-1506
TEL
09777222266
Homepage URL
rinri@heiseikai.com
Sponsor or person
Institute
Sunrise Sakai Hospital
Institute
Department
Personal name
Funding Source
Organization
Sunrise Sakai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto Rehabilitation Hospital Department of Rehabilitation
Yoshihiro Yoshimura
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 28 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032834
| 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 |
