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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039053
Receipt No. R000044537
Scientific Title The effects of the Building Osteo Neatly Exercise programme on bone strength and gait ability in older adults
Date of disclosure of the study information 2020/01/05
Last modified on 2020/01/05

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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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