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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036924
Receipt No. R000042010
Scientific Title Effects of Inspiratory Muscle Training in Frail elderly people on Cough Strength
Date of disclosure of the study information 2019/06/02
Last modified on 2019/06/03

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Basic information
Public title Effects of Inspiratory Muscle Training in Frail elderly people on Cough Strength
Acronym Effects of Inspiratory Muscle Training in Frail elderly people on Cough Strength
Scientific Title Effects of Inspiratory Muscle Training in Frail elderly people on Cough Strength
Scientific Title:Acronym Effects of Inspiratory Muscle Training in Frail elderly people on Cough Strength
Region
Japan

Condition
Condition Frail elderly people
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the aim of this study was the effect of inspiratory muscle training for frail elderly people on improvement of cough strength
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cough peak flow(CPF)
Key secondary outcomes maximum inspiratory mouth pressure(PImax), maximum expiratory mouth pressure(PEmax), FVC, FEV1, repetitive salvia swallowing test(RSST), Tongue pressure, Short Physical Performance Battery(SPPB), Grip strength, Isometric Knee Extension Force, Barthel Index

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 YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In addition to regular rehabilitation, the exercise group will perform inspiratory muscle training for at least 3 days a week for 8 weeks. Inspiratory muscle training is performed twice a day at 30% of PImax 30 times a day(Reassess the load intensity after 4 weeks of intervention).
Interventions/Control_2 The control group performs regular rehabilitation only for 8 weeks.
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) Frail elderly people based on Fried's CHS criteria
2) 65 years or older
3) Person who conducted research explanation and obtained written consent for exercise
Key exclusion criteria 1) In the case where the attending physician or research director decides that it is inappropriate
2) Cases judged to be difficult to conduct IMT
3) Cases where equipment can not be used properly
4) Cases that can not be coughed
5) Cases where 8week intervention is impossible
6) Cases scheduled for surgery within the study period
7) Patients who have difficulty walking by themselves
8) Cases with a history of pneumothorax
9) Cases that have developed cancer
10) A case that exacerbated comorbidity within 4 weeks
Target sample size 60

Research contact person
Name of lead principal investigator
1st name ryo
Middle name
Last name kozu
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Physical Therapy Science
Zip code 852-8520
Address 1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL 095-819-7963
Email ryokozu@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Morishita
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Physical Therapy Science
Zip code 852-8520
Address 1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL 095-819-7963
Homepage URL
Email da1110kj@gmail.com

Sponsor
Institute Nagasaki University
Institute
Department

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 Nagasaki University Graduate School of Biomedical Sciences Academic Cooperation Division
Address 1-12-4 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel 095-819-7195
Email gakujutu_gakuji@ml.nagasaki-u.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 02 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 Open public recruiting
Date of protocol fixation
2019 Year 06 Month 02 Day
Date of IRB
2019 Year 03 Month 29 Day
Anticipated trial start date
2019 Year 06 Month 02 Day
Last follow-up date
2021 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 06 Month 02 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042010

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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