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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017056
Receipt No. R000019779
Scientific Title Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Date of disclosure of the study information 2015/04/06
Last modified on 2016/06/06

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Basic information
Public title Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Acronym Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Scientific Title Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Scientific Title:Acronym Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Region
Japan

Condition
Condition Older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to present the effect of twenty- weeks low load strength training of the quadriceps femoris on muscle function and functional capacity in older adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle thickness and echo intensity of the quadriceps femoris muscle
Maximal isometric strength of the knee extensor muscle
Key secondary outcomes Gait speed
Timed up and go test
30 second chair-stand test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization 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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: 12 weeks low load strength training program of the quadriceps femoris
Interventions/Control_2 Control group: Non-intervention
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) People aged 65 years and over
2) People who are able to ambulate independently
Key exclusion criteria 1) People who had physical dysfunctions that may influence outcome measures, such as neurological impairment and musculoskeletal impairment
2) Have severe dementia
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Ichihashi
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3951
Email ichihashi.noriaki.5z@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Araki
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3951
Homepage URL
Email araki.koujirou.77s@st.kyoto-u.ac.jp

Sponsor
Institute Department of Development and Rehabilitation of Motor Function, Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 06 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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 06 Day
Last modified on
2016 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019779

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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