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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014597
Receipt No. 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

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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
Last 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
Email 11mr09@g.seirei.ac.jp

Public contact
1st 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
Email 11mr09@g.seirei.ac.jp

Sponsor
Institute Iwata City Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016967

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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