UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Title of the study (Brief title)	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	Seiko Nagaoka
Organization	Sunrise Sakai Hospital
Division name	Nursing department
Address	3156-1 Hiji, Hayami, Oita 879-1506
TEL	09777222266
Email	usrknjsnsi@gmal.com

Public contact
Name of contact person	Tetsuo Kobayashi
Organization	Sunrise Sakai Hospital
Division name	Committee of Research, Education and Training
Address	3156-1 Hiji, Hayami, Oita 879-1506
TEL	09777222266
Homepage URL
Email	rinri@heiseikai.com

Sponsor
Institute	Sunrise Sakai Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032834