UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014597 |
|---|---|
| Receipt number | R000016967 |
| Scientific Title | Effects of combination of whey protein intake and rehabilitation on muscle strength and daily movements in patients with hip fracture in the early postoperative period |
| Date of disclosure of the study information | 2014/07/20 |
| Last modified on | 2014/08/01 15:49:57 |
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Basic information
Public title
Effects of combination of whey protein intake and rehabilitation on muscle strength and daily movements in patients with hip fracture in the early postoperative period
Acronym
Effects of combination of whey protein intake and rehabilitation
Scientific Title
Effects of combination of whey protein intake and rehabilitation on muscle strength and daily movements in patients with hip fracture in the early postoperative period
Scientific Title:Acronym
Effects of combination of whey protein intake and rehabilitation
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of combination with whey protein intake and rehabilitation on physical function among patients with hip fracture in the early postoperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Knee extension strength
Key secondary outcomes
Barthel Index
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The control group received physical therapy after surgery.One protocol period was two weeks, but rehabilitation was carried out five times per week.
Interventions/Control_2
The whey protein group received 32 g of whey protein pre- and post-rehabilitation.Patients ingested the whey protein in the daytime on days off from 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
| 62 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with hip fracture aged 60 years or older
Key exclusion criteria
Patients with advanced dementia or delirium, a requirement for tube feeding, contraindication for a high-protein diet, inability to communicate or understand, a swallowing disorder or ambulation difficulty in the prehospital stage were excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Niitsu |
Organization
Iwata City Hospital
Division name
Department of Rehabilitation
Zip code
Address
512-3 Okubo-machi, Iwata-shi, Shizuoka, Japan
TEL
08055496550
11mr09@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Niitsu |
Organization
Iwata City Hospital
Division name
Department of Rehabilitation
Zip code
Address
512-3 Okubo-machi, Iwata-shi, Shizuoka, Japan
TEL
08055496550
Homepage URL
11mr09@g.seirei.ac.jp
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
Iwata City Hospital
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
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
磐田市立総合病院（静岡）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The whey protein group exhibited greater knee extension strength in both limbs than the control group in the final assessment. Transfer, walking and toilet use showed greater improvements in the whey protein group than in the control group by BI. There were significant differences in the change in knee extension strength for both limbs .
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 10 | 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
| 2014 | Year | 07 | Month | 19 | Day |
Last modified on
| 2014 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016967
| Research Plan | |
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| 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 |
