UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023953 |
|---|---|
| Receipt number | R000027577 |
| Scientific Title | The effects of aerobic exercise on physicla funciton in community-dwelling older adutls in korea |
| Date of disclosure of the study information | 2016/09/06 |
| Last modified on | 2016/09/06 15:56:59 |
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Basic information
Public title
The effects of aerobic exercise on physicla funciton in community-dwelling older adutls in korea
Acronym
The effect of Aerobic exercise for community-dwelling older adults.
Scientific Title
The effects of aerobic exercise on physicla funciton in community-dwelling older adutls in korea
Scientific Title:Acronym
The effect of Aerobic exercise for community-dwelling older adults.
Region
| Asia(except 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 effect of aerobic exercise which is called Kohzuki exercise program(KEP) on physical function and mental health for community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Physical function
Short Physical Performance Battery(SPPB)
Key secondary outcomes
Mental health
Medical Outcomes Study 12-Item Short Form Health Survey Instrument(SF-12)
Mini-Mental State Examination(MMSE)
Geriatric Depression Scale(GDS)
Pittsburgh Sleep Quality Index(PSQI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Young-old adults group were required to attend Kohzuki Exercise Program(KEP)sessions 3 times per week for 6 month. Each session lasted minutes, including a 5 minute warming up, a 30 minute lower limb exercise with TERASUERUGO, and a minute cool down. Exercise intensity was a heart rate of 40-60% of the maximum(Borg scale scores of 11-13).
Interventions/Control_2
old-old adults group were required to attend Kohzuki Exercise Program(KEP)sessions 3 times per week for 6 month. Each session lasted minutes, including a 5 minute warming up, a 30 minute lower limb exercise with TERASUERUGO, and a minute cool down. Exercise intensity was a heart rate of 40-60% of the maximum(Borg scale scores of 11-13).
Interventions/Control_3
oldest-old adults group were required to attend Kohzuki Exercise Program(KEP)sessions 3 times per week for 6 month. Each session lasted minutes, including a 5 minute warming up, a 30 minute lower limb exercise with TERASUERUGO, and a minute cool down. Exercise intensity was a heart rate of 40-60% of the maximum(Borg scale scores of 11-13).
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.They were member of the senior community center, and Healthy older adults.
2.were young-old(65-74 years),old-old(75-84 years), oldest-old(85 years and over) adults.
3.were not currently participant in i any form of regular aerobic exercise or strength training
4.informed consent
Key exclusion criteria
1. neuromuscular disorders more difficult to ameliorate with exercise(such as severe Parkinson's disease, stroke etc)
2. were diagnosed active serious illness or conditions that would contraindicate weight training(cancer, myocardial infarct)
3.dementia and other cognitive impairment judged to interfere with following instructions for assessment or exercise
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kouzuki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine & Rehabilitation Science
Zip code
Address
1-1, Seiryo street, Aoba ward, sendai city
TEL
022-717-7351
Kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chaeyoon Cho |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine & Rehabilitation Science
Zip code
Address
1-1, Seiryo street, Aoba ward, sendai city
TEL
022-717-7353
Homepage URL
chocy1127@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showadenki.Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学大学院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 27 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 06 | Day |
Last modified on
| 2016 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027577
