UMIN-CTR Clinical Trial

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
Email	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
Email	ymikami@wakayama-med.ac.jp

Sponsor
Institute	Ministry of education
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053395