UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038510
Receipt number R000043877
Scientific Title Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program
Date of disclosure of the study information 2019/11/15
Last modified on 2020/11/09 10:38:29

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Basic information

Public title

Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program

Acronym

Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program

Scientific Title

Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program

Scientific Title:Acronym

Effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program

Region

Japan


Condition

Condition

healthy elderly person

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the effect of exercise and protein supplementation on the physical function and muscle force in participants in care prevention program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change from baseline of muscle thickness at 3, 6 months.

Key secondary outcomes

1) Change from baseline of five-repetition sit-to-stand test time at 3, 6 months.
2) Change from baseline of 5 m walking speed at 3, 6 months.
3) Change from baseline of Get-Up and Go test time at 3, 6 months
4) Change from baseline of one-legged blind balance time at 3, 6 months
5) Change from baseline of grip strength at 3, 6 months


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

(Exercise group) Drinking water after exercise twice a week at care prevention program of Himi city.

Interventions/Control_2

(Protein group) Taking protein supplement (15g at a time) after exercise twice a week at care prevention program of Himi city.

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

A person who attends care prevention program of Himi city

Key exclusion criteria

1)A person who cannot stand because of pain
2)Diabetic patient (HbA1c > 6.4%)
3)Kidney disease patient (eGFR < 50)
4)A person who is possible aspiration by screening evaluation
5)A person who cannot undergo a physical test

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Koichiro
Middle name
Last name Oka

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

359-1192

Address

2-579-15 Mikajima Tokorozawa, Saitama

TEL

04-2947-6781

Email

koka@waseda.jp


Public contact

Name of contact person

1st name Takuto
Middle name
Last name Nakamura

Organization

Toyama Medical Welfare College

Division name

Department of Physical Therapy

Zip code

936-0023

Address

149-9 Yanagihara Nerikawa,Toyama

TEL

076-476-001

Homepage URL


Email

nakat@tif.ac.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Morinaga & 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

Waseda University

Address

1-104 Totsukamachi, Shinjuku-ku, Tokyo

Tel

03-3202-2568

Email

rps@list.waseda.jp


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

2019 Year 11 Month 15 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

2019 Year 11 Month 01 Day

Date of IRB

2019 Year 10 Month 15 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2020 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 07 Day

Last modified on

2020 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name