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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030769
Receipt No. R000035135
Scientific Title Study on body mass-based resistance training including explosive motion for preventing frailty and/or cognitive decline for community-dwelling elderly
Date of disclosure of the study information 2018/05/01
Last modified on 2021/07/16

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Basic information
Public title Study on body mass-based resistance training including explosive motion for preventing frailty and/or cognitive decline for community-dwelling elderly
Acronym Study on body mass-based resistance training including explosive motion for preventing frailty and/or cognitive decline
Scientific Title Study on body mass-based resistance training including explosive motion for preventing frailty and/or cognitive decline for community-dwelling elderly
Scientific Title:Acronym Study on body mass-based resistance training including explosive motion for preventing frailty and/or cognitive decline
Region
Japan

Condition
Condition Prefrail
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects developed prevention programs for frailty and/or cognitive decline
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Rate of force development in the lower limb following 3 months exercise intervention
Key secondary outcomes Physical (lower limb strength, gait speed, reaction time, balance ability, etc.) and cognitive functions (MoCA-J, trail making test, etc.) following 3, 6, 15 months exercise intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Traditional resistance training for 2days/weeks, 3 months
Interventions/Control_2 Resistance training including explosive motion for 2days/weeks, 3 months
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Community-dwelling elderly who was classed as non-frailty by the Kihon Checklist
Key exclusion criteria Subjects with exercise limitation
Subjects with the certification of needed long-term care
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masafumi
Middle name
Last name Kuzuya
Organization Nagoya university
Division name Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2369
Email kuzuya@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tomoharu
Middle name
Last name Kitada
Organization Seijoh university
Division name Faculty
Zip code 476-8588
Address 2-172 Fukinodai, Tokai-CIty, Aichi, 476-8588, Japan
TEL 052-744-2368
Homepage URL
Email tkitada@coi.nagoya-u.ac.jp

Sponsor
Institute Nagoya university
Institute
Department

Funding Source
Organization Japan science and technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of the Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 052-744-2973
Email ethics@med.nagoya-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 アイレクススポーツクラブ豊田店(愛知県) 
Ilex sports club TOYOTA

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 01 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 45
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Under data analysis
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 20 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 06 Month 06 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 11 Day
Last modified on
2021 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035135

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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