UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028009 |
|---|---|
| Receipt number | R000032074 |
| Scientific Title | Examining effects of protein supplemetation on functional improvement during rehabilitaion intervention in chronic stroke patients |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2019/07/31 02:14:21 |
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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
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
yoshikmj@gmail.com
Sponsor or person
Institute
Department of rehabilitation medicine,
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032074
