UMIN-CTR Clinical Trial

Basic information
Public title	The effects of the Building Osteo Neatly Exercise programme on bone strength and gait ability in older adults
Acronym	The Building Osteo Neatly Exercise programme and The effects of the Building Osteo Neatly Exercise programme and bone strength and gait ability in older adults
Scientific Title	The effects of the Building Osteo Neatly Exercise programme on bone strength and gait ability in older adults
Scientific Title:Acronym	The Building Osteo Neatly Exercise programme and The effects of the Building Osteo Neatly Exercise programme and bone strength and gait ability in older adults
Region	Japan

Condition
Condition	ADL and IADL disabilities
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of the Building Osteo Neatly Exercise (BONE) programme on gait speed, plantar pressure distribution and bone strength in older adults with activities of daily living (ADL) and/or instrumental activities of daily living (IADL) disabilities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gait speed
Key secondary outcomes	plantar pressure distribution and bone strength

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	To performe the BONE programme for 60 min twice a week over a course of 4 months
Interventions/Control_2	Control group
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	75 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) aged 75 or older, 2) able to walk 6 m without a gait aid, 3) able to comprehend the study procedures and 4) diagnosed by a medical doctor to the Support level 1-2 or the Care level 1-2 of the ADL and IADL disabilities, according to the definition of the Japanese government.
Key exclusion criteria	1) contraindicated for participation in the study, 2) diagnosed with a rapidly progressive or terminal illness
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Shiho Middle name Last name Kurosaka
Organization	Hiroshima University
Division name	Graduate School of Education
Zip code	739-8524
Address	1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, 739-8524 Japan
TEL	+81-82-424-6844
Email	shihok@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shiho Middle name Last name Kurosaka
Organization	Hiroshima University
Division name	Graduate School of Education
Zip code	739-8524
Address	1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, 739-8524 Japan
TEL	+81-82-424-6844
Homepage URL
Email	shihok@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	the Japan Society for the Promotion of Science
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	the Research Ethics Committee of the Graduate School of Education, Hiroshima University
Address	1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, 739-8524 Japan
Tel	+81-82-424-6705
Email	ed-sou-jin@office.hiroshima-u.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	2020 Year 01 Month 05 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	27
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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 06 Month 30 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 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	2020 Year 01 Month 05 Day
Last modified on	2020 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044537

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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