UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039941
Receipt number R000045543
Scientific Title A study on improvement of respiratory function in the elderly living at home
Date of disclosure of the study information 2020/03/28
Last modified on 2020/03/25 18:58:47

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Basic information

Public title

A study on improvement of respiratory function in the elderly living at home

Acronym

A study on improvement of respiratory function in the elderly living at home

Scientific Title

A study on improvement of respiratory function in the elderly living at home

Scientific Title:Acronym

A study on improvement of respiratory function in the elderly living at home

Region

Japan


Condition

Condition

Elderly living at home

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The necessity of maintaining and improving respiratory function for elderly people living in the community to prevent aspiration is confirmed, and the respiratory function improvement program for preventing aspiration from an early stage and its effect are verified.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary outcomes will be measured by (1) respiratory function measurements.
Evaluations are made immediately before the respiratory function improvement program and three months after the intervention.

Key secondary outcomes

Primary outcomes will be measured by (2) self-administered questionnaire surveys, etc.
Evaluations are made immediately before the respiratory function improvement program and three months after the intervention.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

A (+) intervention group

Preventive intervention with respiratory function improvement program
Conduct place: Home and salon
B Control group (no intervention)



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


Not applicable

Gender

Male and Female

Key inclusion criteria

Elderly living at home
People without dementia

Key exclusion criteria

dementia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takemi
Middle name
Last name Matsuda

Organization

Faculty of nursing, Chubu Gakuin University

Division name

Faculty of Human Welfare

Zip code

501-3993

Address

2-1 Kirigaoka, Seki City, Gifu Prefecture

TEL

0575-24-2211

Email

matsuda-takemi@chubu-gu.ac.jp


Public contact

Name of contact person

1st name Takemi
Middle name
Last name Matsuda

Organization

University of Human Environments

Division name

Graduate School of Nursing

Zip code

474-0035

Address

3-220 Ebata-cho, Obu City, Aichi Prefecture

TEL

0562-43-0701

Homepage URL


Email

dn17008@uhe.ac.jp


Sponsor or person

Institute

Faculty of nursing, Chubu Gakuin University

Institute

Department

Personal name



Funding Source

Organization

Faculty of nursing, Chubu Gakuin University

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

University of Human Environments

Address

3-220 Ebata-cho, Obu City, Aichi Prefecture

Tel

0575-24-2211

Email

dn17008@uhe.ac.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

2020 Year 03 Month 28 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

25

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

No longer recruiting

Date of protocol fixation

2018 Year 10 Month 30 Day

Date of IRB

2018 Year 10 Month 30 Day

Anticipated trial start date

2020 Year 03 Month 28 Day

Last follow-up date

2020 Year 08 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

2020 Year 03 Month 25 Day

Last modified on

2020 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045543


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name