UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041374 |
|---|---|
| Receipt number | R000047235 |
| Scientific Title | To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation Effect of injury |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/10 13:13:40 |
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Basic information
Public title
To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury
Acronym
To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury
Scientific Title
To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury
Scientific Title:Acronym
To the health behaviors related to exercise of life-stage rehabilitation subjects Shared decision making and motivation
Effect of injury
Region
| Japan |
Condition
Condition
Target of rehabilitation (outpatient/outpatient/visit/gymnastic class) in our life
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of shared decision-making and motivation on the health behaviors of life-stage rehabilitation subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Basic information
Target: Age, gender, main disease name, insurance information (medical insurance, degree of long-term care)
Rehabilitation type (outpatient/outpatient/visit/gymnastic classroom)
Frequency of use (times/week), period from start of use
2.Physical function evaluation
Gait Independence: Functional Ambulation Classification of the Hospital at Sagunto
Lower limb strength: knee extension strength
3.Shared decision evaluation
Shared Decision Making for Rehabilitation
Decision Preference: Control Preference Scale
Strength of Motivation: Behavioral Regulation in Exercise Questionnaire-2
4.Exercise health evaluation
Information on the amount of physical activity in daily life
Level of understanding and adherence to self-practice
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target of rehabilitation (outpatient/outpatient/visit/gymnastic class) in our life
Key exclusion criteria
Persons with cognitive dysfunction that makes it difficult to answer all survey items and manage physical activity
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kousuke |
| Middle name | |
| Last name | Hirata |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Kousuke |
| Middle name | |
| Last name | Hirata |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
https://kawaguchi-ns.com
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Koriencho, Hirakata City, Osaka
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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
川口脳神経外科リハビリクリニック（大阪府）、西大和リハビリテーション病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic information survey, physical function evaluation, and questionnaire items are surveyed during normal clinical time, and only physical activity measurements are surveyed outside normal clinical time.
A physical activity meter (HJA-750C, made by OMRON) is attached to either the left or right waist of the subject.
Continuously measure the amount of physical activity shown in daily life for 3 to 7 days (from waking up to bed except when taking a bath).
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047235
