UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of aerobic exercise on physicla funciton in community-dwelling older adutls in korea
Title of the study (Brief title)	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	Masahiro Kouzuki
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Internal Medicine & Rehabilitation Science
Address	1-1, Seiryo street, Aoba ward, sendai city
TEL	022-717-7351
Email	Kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person	Chaeyoon Cho
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Internal Medicine & Rehabilitation Science
Address	1-1, Seiryo street, Aoba ward, sendai city
TEL	022-717-7353
Homepage URL
Email	chocy1127@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027577