UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036282
Receipt number R000041325
Scientific Title Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults
Date of disclosure of the study information 2019/04/01
Last modified on 2020/05/14 23:22:02

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Basic information

Public title

Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults

Acronym

Effect of inspiratory muscle training in frail older adults

Scientific Title

Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults

Scientific Title:Acronym

Effect of inspiratory muscle training in frail older adults

Region

Japan


Condition

Condition

Frail older adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Respiratory muscle strength

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

Inspiratory muscle training(30 repetitions per day,at least 5 days per week,for 4 weeks)

Interventions/Control_2

No intervention

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

1.Persons who are using "Medical corporation Yamato Seishinkai Geriatric health services facility Shobuen day care services "
2.Persons who can acquire the consent of research participation,from his/her and family
3.Persons certified in long-term care insurance(at least 65years old)
4.Persons who exist muscle weakness(grip strength: male <26 kg, female <18 kg), physical function deterioration(normal walking speed <=1.0 m/sec)
5.Persons corresponding to either one of the two items of weight loss and fatigue based on J-CHS

Key exclusion criteria

1.Persons who cannot conduct inspection / measurement
2.Persons who have a FEV1.0% less than 70%
3.Persons who has serious heart disease
4.Persons who has pneumothorax in past medical history
5.Persons who have poor control for pain at the time of examination
6.Persons who cannot follow the indicated action due to dementia or psychiatric symptoms
7.Persons who cannot obtain consent for this research

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hideo
Middle name
Last name Kaneko

Organization

International University of Health and Welfare

Division name

School of Health Sciences at Fukuoka

Zip code

831-0004

Address

137-1 Enokizu,Okawa-shi,Fukuoka,Japan

TEL

0944-89-2000

Email

hkaneko@iuhw.ac.jp


Public contact

Name of contact person

1st name Suguru
Middle name
Last name Nonaka

Organization

Medical Corporation Yamato Seishinkai Fujioka Hospital

Division name

Department of Rehabilitation

Zip code

840-0201

Address

2685 Niiji,Yamato-cho,Saga-shi,Saga,Japan

TEL

0952-62-2200

Homepage URL


Email

18S1134@g.iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

International University of Health and Welfare,Institutional Review Board

Address

137-1 Enokizu,Okawa-shi,Fukuoka,Japan

Tel

0944-89-2031

Email

oocamp@iuhw.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 04 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

15

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 03 Month 31 Day

Date of IRB

2018 Year 12 Month 25 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 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 03 Month 24 Day

Last modified on

2020 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=R000041325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name