UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046799 |
|---|---|
| Receipt number | R000053395 |
| Scientific Title | Effect of Exercise for the Adults with Spinal Cord Injury Using Scientific Exercise Guideline -Preliminary Randomized Controlled Trial- |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/01 20:11:44 |
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Basic information
Public title
Effect of Exercise for the Adults with Spinal Cord Injury Using Scientific Exercise Guideline
Acronym
Effect of Exercise for the Adults with Spinal Cord Injury
Scientific Title
Effect of Exercise for the Adults with Spinal Cord Injury Using Scientific Exercise Guideline -Preliminary Randomized Controlled Trial-
Scientific Title:Acronym
Effect of Exercise for the Adults with Spinal Cord Injury Using Scientific Exercise Guideline
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a pilot study to evaluate the preliminary effectiveness of exercise using the Japanese version of "Scientific Exercise Guideline for Adults with SCI" to explore the effectiveness of exercise for adult spinal cord injury in Asian countries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Maximum oxygen uptake, upper limb muscle strength (grip strength)
Key secondary outcomes
Body composition (muscle / fat mass), blood biochemical test results (blood glucose / lipid / liver function / renal function), amount of activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rehabilitation
Interventions/Control_2
6months
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults with chronic spinal cord injury who are living at home, have no exercise habits, and are outpatients.
Key exclusion criteria
Adults with cervical spinal cord injury, spinal cord injury less than 12 months after onset, elderly people over 65 years old, people with comorbidities such as cognitive dysfunction / mental disorder, people with chronic diseases that are not appropriate for exercise, Patients with inadequate measurement of maximum oxygen uptake.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Mikami |
Organization
Wakayama Medical University
Division name
Rehabilitation Medicine
Zip code
6418509
Address
Kimiidera 811-1, Wakayama city
TEL
+81-73-441-0664
ymikami@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Mikami |
Organization
Wakayama Medical University
Division name
Rehabilitation Medicine
Zip code
6418509
Address
Kimiidera 811-1, Wakayama city
TEL
+81-73-441-0664
Homepage URL
ymikami@wakayama-med.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Research Ethics Committee of Wakayama Medical University
Address
Kimiidera 811-1, Wakayama city
Tel
+81-73-447-2300
wa-rinri@wakayama-med.ac.jp
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
| 2022 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053395
