UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030769 |
|---|---|
| Receipt number | 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 | 2022/07/20 20:53:48 |
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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
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
tkitada@coi.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035135
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
