UMIN-CTR Clinical Trial

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	No longer 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	2021 Year 11 Month 01 Day

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