UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027786
Receipt number R000031841
Scientific Title Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training.
Date of disclosure of the study information 2017/06/16
Last modified on 2019/06/04 12:22:53

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Basic information

Public title

Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training.

Acronym

Development of exercise equipment for frail elderly

Scientific Title

Quantitative study of health promotion effect by exercise equipment. Strength and QOL effect of frail elderly using hybrid training.

Scientific Title:Acronym

Development of exercise equipment for frail elderly

Region

Japan


Condition

Condition

frail elderly

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The main purpose is to develop exercise equipment for frail elderly.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle strength

Key secondary outcomes

QOL
muscle thickness
abiluty of gait
ability of balance


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Electrical stimulation

Interventions/Control_2

No electrical stimulation

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

60 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Elderly people without hindrance to exercise

Key exclusion criteria

Cognitive disorders

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name yoshio TAKANO

Organization

International university of health and welfare

Division name

school of health science, fukuoka

Zip code


Address

137-1 enokuzu Okawa Fukuoka

TEL

0944-89-2000

Email

y-takano@iuhw.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name yoshio TAKANO

Organization

International university of health and welfare

Division name

school of health science, fukuoka

Zip code


Address

137-1 enokuzu Okawa Fukuoka

TEL

0944-89-2000

Homepage URL


Email

y-takano@iuhw.ac.jp


Sponsor or person

Institute

school of health science, fukuoka

Institute

Department

Personal name



Funding Source

Organization

Panasonic Corporation

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


Email



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

2017 Year 06 Month 16 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

2017 Year 06 Month 16 Day

Date of IRB

2017 Year 05 Month 29 Day

Anticipated trial start date

2017 Year 06 Month 16 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 16 Day

Last modified on

2019 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name