UMIN-CTR Clinical Trial

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
Email	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
Email	wakidam@kouri.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043125