UMIN-CTR Clinical Trial

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	48
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	manuscript in preparation
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 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	2022 Year 07 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035135