UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037463 |
|---|---|
| Receipt number | 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 16:27:10 |
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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
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
harazu_21@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041955
