UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047831
Receipt number R000054478
Scientific Title Dietary variety and its associated factors in day rehabilitation users.
Date of disclosure of the study information 2022/05/23
Last modified on 2024/03/23 05:36:39

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Basic information

Public title

Dietary variety and its associated factors in day rehabilitation users.

Acronym

Dietary variety and its associated factors in day rehabilitation users.

Scientific Title

Dietary variety and its associated factors in day rehabilitation users.

Scientific Title:Acronym

Dietary variety and its associated factors in day rehabilitation users.

Region

Japan


Condition

Condition

Diseases common in the elderly

Classification by specialty

Medicine in general Surgery in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to clarify the relationship between nutritional status, including food intake, and physical, cognitive, and lifestyle functions among community-dwelling elderly people who use day care rehabilitation facilities, and to help understand the actual situation.
The purpose of this study was to clarify the relationship between nutritional status, including food intake, and physical, cognitive, and lifestyle functions, and to help understand the actual conditions of the elderly.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study was to clarify the relationship between nutritional status, including food intake, and physical, cognitive, and lifestyle functions among community-dwelling elderly people who use day care rehabilitation facilities, and to help understand the actual situation.
The purpose of this study was to clarify the relationship between nutritional status, including food intake, and physical, cognitive, and lifestyle functions, and to help understand the actual conditions of the elderly.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

length, weight, BMI, lower leg circumference, and food

Key secondary outcomes

MNASF, SPPB, MMSE, ADL, IADL, Grip Strength, Knee Extension Tendon Strength


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

65 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Those who have been using the program for at least 3 months (weight progress can be confirmed for the 3 months prior to the start of use).
(2) Those who are in stable physical condition.
(3) Able to stand and walk to some extent
(4) Persons of any gender
(5) Patients who have been fully informed of the participation in this study, and who have given written consent of their own free will based on sufficient understanding.
(6)Patients 65 years of age or older who have been certified as requiring long-term care
(7) Patients aged 65 or older who are eligible for comprehensive projects for care prevention and daily life support.

Key exclusion criteria

(1) Those who have been using the service for less than 3 months (weight progress cannot be confirmed for the 3 months prior to the start of use).
(2) Those who have difficulty standing or walking.
(3) Those who have difficulty in measurement due to a marked decline in cognitive function.
(4) Those with marked edema of the lower limbs
(5) Those who are judged to be inappropriate as subjects by the principal investigator.
(6) Those who cannot cooperate with the research
(vii) Those who are not taking the food orally.


Target sample size

67


Research contact person

Name of lead principal investigator

1st name yoshitsugu
Middle name
Last name fujii

Organization

Tokuyama Central Hospital Nursing and Health Care Facility for the Elderly

Division name

hospital department

Zip code

745-0822

Address

1-1 kouda-cho, Shunan-shi, Yamaguchi

TEL

0834-28-8686

Email

yo429rpt@gmail.com


Public contact

Name of contact person

1st name yoshitsugu
Middle name
Last name fujii

Organization

Tokuyama Central Hospital Nursing and Health Care Facility for the Elderly

Division name

hospital department

Zip code

745-0822

Address

1-1 kouda-cho, Shunan-shi, Yamaguchi

TEL

0834-28-8686

Homepage URL


Email

yo429rpt@gmail.com


Sponsor or person

Institute

Tokuyama Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokuyama Central Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokuyama Central Hospital Nursing and Health Care Facility for the Elderly

Address

1-1 kouda-cho, Shunan-shi, Yamaguchi

Tel

0834-28-8686

Email

yo429rpt@gmail.com


Secondary IDs

Secondary IDs

YES

Study ID_1

K432-20220511

Org. issuing International ID_1

Tokuyama Central Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

徳山中央病院附属介護老人保健施設デイケア(山口県)


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 23 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

Terminated

Date of protocol fixation

2022 Year 05 Month 11 Day

Date of IRB

2023 Year 10 Month 05 Day

Anticipated trial start date

2022 Year 06 Month 01 Day

Last follow-up date

2026 Year 10 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cancellation of examinations due to the closure of day rehabilitation centers.


Management information

Registered date

2022 Year 05 Month 23 Day

Last modified on

2024 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054478


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name