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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009624
Receipt No. R000011291
Scientific Title Development of physical training program for patients with dementia
Date of disclosure of the study information 2012/12/25
Last modified on 2014/06/25

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Basic information
Public title Development of physical training program for patients with dementia
Acronym Development of physical training program for patients with dementia
Scientific Title Development of physical training program for patients with dementia
Scientific Title:Acronym Development of physical training program for patients with dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether a specific, standardized training regimen can improve muscle strength and physical functioning in people with dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Maximum knee extension strength
10 m-gait performance test
Time Up and Go Test
Functional Independence Measure
Key secondary outcomes Mini-Mental State Examination
Dementia Behavior Disturbance Scale

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
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: Resistance training was targeted at knee extension muscle groups at a submaximal intensity (65% of one-repetition maximum) for 10 months (3 sets of 8 repetitions, three times a week) supervised by a qualified instructor.
Interventions/Control_2 Control group: Typical activities were flexibility exercise, calisthenics,
low-intensity training.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Eligibility criteria included presence of dementia, absence of delirium, palsy, or knee pain and injury, and the desire to participate in the study.
Key exclusion criteria Individuals were excluded if they could not push against the dynamometer with their leg with physical guidance.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Suzuki
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8874
Email maksuzu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Suzuki
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8874
Homepage URL
Email maksuzu@gmail.com

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Research Grants in the Humanities from the Mitsubishi Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Setagaya Municipal Kitazawa En
Hatsutomi Hoken Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 世田谷区立きたざわ苑(東京都)
初富保健病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 25 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
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
2012 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 25 Day
Last follow-up date
2013 Year 12 Month 25 Day
Date of closure to data entry
2014 Year 10 Month 25 Day
Date trial data considered complete
2014 Year 10 Month 25 Day
Date analysis concluded
2014 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 25 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011291

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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