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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037463
Receipt No. R000041955
Scientific Title The Effects of a Multi-component Lower Extremity Training Technique on Physical Function in Healthy Older Adults
Date of disclosure of the study information 2019/07/25
Last modified on 2020/02/20

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Basic information
Public title The Effects of a Multi-component Lower Extremity Training Technique on Physical Function in Healthy Older Adults
Acronym The Effects of a Multi-component Lower Extremity Training Technique on Physical Function in Healthy Older Adults
Scientific Title The Effects of a Multi-component Lower Extremity Training Technique on Physical Function in Healthy Older Adults
Scientific Title:Acronym The Effects of a Multi-component Lower Extremity Training Technique on Physical Function in Healthy Older Adults
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the impact of multi-component lower extremity training on physical function in older adults by assessing range of motion, muscle strength, and physical performance ability
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lower extremity range of motion (hip flexion, hip abduction, hip adduction, hip extension, internal and external hip rotations, knee flexion, ankle dorsiflexion, and ankle plantar flexion) / baseline, after 24 weeks
Key secondary outcomes The functional reach test, timed up and go test, and five times sit-to-stand test

Two types of muscle strength (knee extension and flexion)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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
Other
Interventions/Control_1 Multi-component lower extremity training /
once per week for 24 weeks / Interventions
Interventions/Control_2 No training exercises for 24 weeks / Control
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 (a) 65 years of age or older (b) living independently in the community (c) the ability to perform activities of daily living without assistance (d) no cognitive impairment to disturb understanding of the written informed consent (e) no serious neurological, musculoskeletal, visual, sensory, or cognitive disorders diagnosed by clinicians, which would preclude voluntary participation in a weekly group exercise program (f) no use of walking aids, such as a cane, walker, or crutches.
Key exclusion criteria 1) under 65 years
2) severe neurological disorder such as stroke
3) inhibited to intensive exercising by physician
4) positive diagnosis of dementia
5) positive diagnosis of articular rheumatism
6) no ability to perform activities of daily living
Target sample size 41

Research contact person
Name of lead principal investigator
1st name Hungu
Middle name
Last name Jung
Organization Hiroshima University
Division name Graduate School of Integrated Arts and Sciences
Zip code 739-8521
Address 1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL 082-424-6585
Email harazu_21@yahoo.co.jp

Public contact
Name of contact person
1st name Hungu
Middle name
Last name Jung
Organization Hiroshima University
Division name Graduate School of Integrated Arts and Sciences
Zip code 739-8521
Address 1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL 082-424-6585
Homepage URL
Email harazu_21@yahoo.co.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hiroshima University
Address 1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
Tel 082-424-6306
Email souka-soumu@office.hiroshima-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

Other administrative information
Date of disclosure of the study information
2019 Year 07 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 33
Results
After 24 weeks, significant increments were observed in the TG with significant interaction, with regard to all ROMs (except knee flexion), knee extension strength, and the TUGT and FTSST.
 Improvements in ROMs ranged from 5.3% (ankle plantar flexion) to 33.3% (hip extension).
 The knee extension strength showed a significant increment by 14.1%.
 Significant improvements were found in the TUGT (13.6%), and in the FTSST (13.1%).
Results date posted
2019 Year 07 Month 23 Day
Results Delayed
Delay expected
Results Delay Reason not accepted
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
2014 Year 12 Month 25 Day
Date of IRB
2014 Year 12 Month 25 Day
Anticipated trial start date
2014 Year 12 Month 25 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 24 Day
Last modified on
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041955

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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