UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006260
Receipt number R000007312
Scientific Title The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan
Date of disclosure of the study information 2011/09/01
Last modified on 2011/08/31 15:08:36

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Basic information

Public title

The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan

Acronym

The effect of exercise program at a day service facility

Scientific Title

The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan

Scientific Title:Acronym

The effect of exercise program at a day service facility

Region

Japan


Condition

Condition

elderly persons certified by long-term care

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to investigate the effect of "low-intensity resistance training with slow movement and tonic generation" on physical fitness of elderly persons certified by long-term care insurance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

30-second chair-stand test

Key secondary outcomes

knee extension force(kg),3m timed up and go test(sec.),single-leg standing(sec.),functional reach(cm),grip strength(kg),weight(kg),long-term care need condition


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Low-intensity resistance training with Slow movement and Tonic force generation

Interventions/Control_2


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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

persons certified in long-term care insurance
persons who can walk

Key exclusion criteria

persons not certified in long-term care insurance
persons who can not walk
person who have hypertension and are not treated(over 180/110mmHg)
persons who have severe osteoporosis
persons who have heart diseases that are not controlled
persons who are recommended not to do exercise from their family doctors

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hayamizu Satoshi

Organization

Sanno Rehab. Clinic

Division name

a division of medical service

Zip code


Address

3-4-2 higashiyukigaya,Ohta-ward,Tokyo

TEL

03-5754-2672

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hayamizu Satoshi

Organization

Sanno Rehab. Clinic

Division name

a division of medical service

Zip code


Address

3-4-2 higashiyukigaya,Ohta-ward,Tokyo

TEL

03-5754-2672

Homepage URL


Email

nss16@msn.com


Sponsor or person

Institute

Sanno Rehab. Clinic

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo Bay Rehabilitation Hospital

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

山王リハビリ・クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 01 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

Enrolling by invitation

Date of protocol fixation

2011 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 08 Month 31 Day

Last modified on

2011 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name