UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034984
Receipt number R000039897
Scientific Title A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Date of disclosure of the study information 2019/01/01
Last modified on 2021/05/14 13:31:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults

Acronym

Original community-based exercise program and nutrition support study

Scientific Title

A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults

Scientific Title:Acronym

Original community-based exercise program and nutrition support study

Region

Japan


Condition

Condition

Healthy elderly adults (60years old or more)

Classification by specialty

Neurology Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of original community-based exercise program and nutritional support associated with the improvement of cognitive and physical functions among the elderly.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

General cognitive function test
Body composition , Muscle mass,
Gait speed, Grip strength
Trail making test

Key secondary outcomes

Activities of daily living: Kihon checklist, Instrumental Activities of Daily Living (IADL)
Psychological function: Quality of Life (QOL), Geriatric Depression Scale (GDS), Life satisfaction


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervention group: Perform original community-based exercise program for 10 sessions over 3 months. Intervention group should consume a peptide beverage (containing 4000 mg of soybean peptide) for 1 month over 3 months.

Interventions/Control_2

Control group: Original community-based exercise program for the elderly should be performed in 10 sessions over 3 months.Next, exercise is done using DVDs for 3 months.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Elderly adults who have participated
in cohort studies, 2) Native speaker
3) No limitations on age, sex, and medications.

Key exclusion criteria

1)Doctors orders to stop exercise
2) Medically advised not to participate in exercise
3) Dementia

Target sample size

72


Research contact person

Name of lead principal investigator

1st name Masakazu
Middle name
Last name Imaoka

Organization

Osaka Kawasaki Rehabilitation University

Division name

Department of Rehabilitation

Zip code

598-0016

Address

158 Mizuma, Kaizuka City, Osaka Prefecture

TEL

0724152856

Email

imaokamasakazu@gmail.com


Public contact

Name of contact person

1st name Masakazu
Middle name
Last name Imaoka

Organization

Osaka Kawasaki Rehabilitation University

Division name

Department of Rehabilitation

Zip code

598-0016

Address

158 Mizuma, Kaizuka City, Osaka Prefecture

TEL

072-446-6700

Homepage URL


Email

imaokamasakazu@gmail.com


Sponsor or person

Institute

Osaka Kawasaki Rehabilitation University

Institute

Department

Personal name



Funding Source

Organization

FUJI OIL CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Kawasaki Rehabilitation University

Address

158 Mizuma, Kaizuka City, Osaka Prefecture

Tel

072-446-6700

Email

imaokamasakazu@gmail.com


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 01 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

Completed

Date of protocol fixation

2018 Year 12 Month 20 Day

Date of IRB

2018 Year 09 Month 15 Day

Anticipated trial start date

2019 Year 01 Month 24 Day

Last follow-up date

2019 Year 04 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 24 Day

Last modified on

2021 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039897


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name