UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037070
Receipt number R000042242
Scientific Title Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Date of disclosure of the study information 2019/06/14
Last modified on 2020/12/17 15:25:41

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Basic information

Public title

Evaluation of cough peak flow and effect of cough training on community dwelling elderly people

Acronym

Evaluation of cough peak flow and effect of cough training on community dwelling elderly people

Scientific Title

Evaluation of cough peak flow and effect of cough training on community dwelling elderly people

Scientific Title:Acronym

Evaluation of cough peak flow and effect of cough training on community dwelling elderly people

Region

Japan


Condition

Condition

Community dwelling elderly people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of cough peak flow and its relation to diaphragmatic movement, also effect of cough training using peak flow meter on cough strength on community dwelling elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cough peak flow

Key secondary outcomes

Pulmonary function(spirometry)
Diaphragmatic movement
Lateral abdominal muscle thickness


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

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Cough training using peak flow meter, chest expansion exercise, diaphragmatic breathing exercise, abdominal muscle exercise

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

Community dwelling elderly people who participate to the health promotion class regarding cough function and give informed consent for cooperation to the survey.

Key exclusion criteria

Persons who have no intention of cooperation to the survey and have physical dysfunction that may influence to outcome measures.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kouji
Middle name
Last name Ihashi

Organization

Fukushima medical university

Division name

Preparing section for new faculty of medical science

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima City Fukushima, 960-1295

TEL

024-547-1951

Email

ihashi@fmu.ac.jp


Public contact

Name of contact person

1st name Kouji
Middle name
Last name Ihashi

Organization

Fukushima Medical University

Division name

Preparing section for new faculty of medical science

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima City Fukushima, 960-1295

TEL

024-547-1951

Homepage URL


Email

ihashi@fmu.ac.jp


Sponsor or person

Institute

Fkushima medical university

Institute

Department

Personal name



Funding Source

Organization

Fukushima prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University

Address

1 Hikarigaoka, Fukushima City Fukushima, 960-1295

Tel

024-547-1825

Email

rs@fmu.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

2019 Year 06 Month 14 Day


Related information

URL releasing protocol

UMIN-CTR

Publication of results

Unpublished


Result

URL related to results and publications

UMIN-CTR

Number of participants that the trial has enrolled

13

Results

The participants were 13 elderly people. Only 7 participants completed 3 months cough training including cough training using peak flow meter, chest expansion exercise, diaphragmatic breathing exercise, abdominal muscle exercise. Cough peak flow as the main outcome was not significant improvement. Secondary outcomes including pulmonary function(spirometry), diaphragmatic movement and lateral abdominal muscle thickness measured by ultrasound imaging were also not significant improvement.

Results date posted

2020 Year 12 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The participants were 13 community dwelling elderly people with 12 female and 1 male, with mean age 75.4(6.4). Mean age of seven participants with 6 female and 1 male who completed 3 months cough training were 76.7(5.5).


Participant flow

This study is uncontrolled single arm trial. Seven of 13 participants completed 3 months cough training and pre-post evaluation, while other participants were lack of training and/or evaluation.

Adverse events

There was no adverse event.

Outcome measures

primary outcome was cough peak flow. Secondary outcomes including pulmonary function(spirometry), diaphragmatic movement and lateral abdominal muscle thickness measured by ultrasound imaging.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2019 Year 04 Month 15 Day

Date of IRB

2019 Year 04 Month 15 Day

Anticipated trial start date

2019 Year 06 Month 18 Day

Last follow-up date

2019 Year 09 Month 17 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 06 Month 14 Day

Last modified on

2020 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name