UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037824 |
|---|---|
| Receipt number | R000043125 |
| Scientific Title | Effects of weight-bearing training by stepper exercise on walking performance in older adults - a randomized control trial- |
| Date of disclosure of the study information | 2019/08/27 |
| Last modified on | 2022/02/28 13:32:33 |
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Basic information
Public title
Effects of weight-bearing training by stepper exercise on walking performance in older adults
Acronym
Effects of weight-bearing training by stepper exercise
Scientific Title
Effects of weight-bearing training by stepper exercise on walking performance in older adults - a randomized control trial-
Scientific Title:Acronym
Effects of weight-bearing training by stepper exercise
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of weight-bearing training by stepper exercise on walking performance in community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of walking performance just after and after 1 month of weight-bearing training (forefoot loading, speed, and stride length).
Key secondary outcomes
Ability of ascending and descending stairs (forefoot loading and speed)
Muscle strength (hip abduction, knee extension, and ankle plantar-flexion)
Balance (Berg balance scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Weight-bearing training by robot-driven stepper exercise (12 sessions, 20 minutes/session for 12 weeks)
Interventions/Control_2
Weight-bearing training by conventional stepper exercise (12 sessions, 20 minutes/session for 12 weeks)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Independent indoor walking without a cane
Key exclusion criteria
Joint diseases affecting gait
Severe cognitive disorders
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Wakida |
Organization
Kansai Medical University Kori Hospital
Division name
Day-care center
Zip code
572-8551
Address
45 Korihondori-cho 8, Neyagawa city, Osaka
TEL
+81-72-832-5060
wakidam@kouri.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Wakida |
Organization
Kansai Medical University Kori Hospital
Division name
Day-care center
Zip code
572-8551
Address
45 Korihondori-cho 8, Neyagawa city, Osaka
TEL
+81-72-832-5060
Homepage URL
wakidam@kouri.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shinmachi, Hirakata city, Osaka
Tel
+81-72-804-2440
rinriirb@hirakata.kmu.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
関西医科大学香里病院（大阪府）、関西医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 27 | 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
| 2019 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | 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
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043125
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
