UMIN-CTR Clinical Trial

Basic information
Public title	Examining effects of protein supplemetation on functional improvement during rehabilitaion intervention in chronic stroke patients
Acronym	Synergetic effects of exercise and protein supplementation for chronic stroke patients
Scientific Title	Examining effects of protein supplemetation on functional improvement during rehabilitaion intervention in chronic stroke patients
Scientific Title:Acronym	Synergetic effects of exercise and protein supplementation for chronic stroke patients
Region	Japan

Condition
Condition	chronic stroke
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examining whether effects of exercise therapy and protein supplementation immediately after exercise on gait function, activities daily life (ADL), physical fitness, and blood volume during rehabilitaion in chronic stroke patients will be greater than those in placebo group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Increases in plasma volume (albumine content), muscle strength of lower extremities, and cytokine level in blood
Key secondary outcomes	aerobic capacity, Fugl-Meyer assessment, 6-min walking distance, and 10-m walking speed

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	From 1 to 4 weeks during hospitalization 5days/week whey protein 0.1~0.2g/kg
Interventions/Control_2	From 1 to 4 weeks during hospitalization 5days/week carbohydrate with similar calorie to supplementation durin intervention
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) A patient whose onsets of stroke pass over 6 months 2) A patient who can walk by themselves with or without walking aids or braces 3) A patient who preserves communication ability 4) A patient whom a medical doctor approves for participating the present study
Key exclusion criteria	1) A patient who has lesions in the brainstem 2) A patient who has cardiovascular and respiratoly diseases which interferes gait function instabilities of locomotory system 3) A patient who has a possibility for an instability of motor organs 4) A patient who has heaptic and/ or renal dsiorder 5) A patient who has a history of diabetes that poorly controlled. 6) A patient who has allergies of medicines
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshi-ichiro Kamijo
Organization	Wakayama Medical University
Division name	Department of rehabilitation medicine
Zip code
Address	811-1 Kimiidera
TEL	073-441-0664
Email	yoshikmj@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Yoshi-ichiro Kamijo
Organization	Wakayama Medical University
Division name	Department of rehabilitation medicine
Zip code
Address	811-1 Kimiidera
TEL	073-441-0664
Homepage URL
Email	yoshikmj@gmail.com

Sponsor
Institute	Department of rehabilitation medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 30 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	Completed
Date of protocol fixation	2017 Year 06 Month 16 Day
Date of IRB	2017 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 06 Month 27 Day
Last follow-up date	2019 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 30 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032074