UMIN-CTR Clinical Trial

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

healthy Older adults

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

Kohzuki@med.tohoku.ac.jp

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

Email

chocy1127@med.tohoku.ac.jp

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Showadenki.Co.Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学大学院(宮城県)

Date of disclosure of the study information

2016

Year

09

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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