UMIN-CTR Clinical Trial

Basic information
Public title	Effect of expiratory muscle training for the elderly patients before cardiovascular surgery on postoperative pressure expiratory maximum.
Acronym	Effect of expiratory muscle training for the elderly patients before cardiac surgery on postoperative pressure expiratory maximum.
Scientific Title	Effect of expiratory muscle training for the elderly patients before cardiovascular surgery on postoperative pressure expiratory maximum.
Scientific Title:Acronym	Effect of expiratory muscle training for the elderly patients before cardiac surgery on postoperative pressure expiratory maximum.
Region	Japan

Condition
Condition	Elderly patients of cardiac surgery scheduled
Classification by specialty	Cardiovascular surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to examine the safety and efficacy of expiratory muscle training for elderly patients before cardiac surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	7th day after surgery the pressure expiratory maximum
Key secondary outcomes	incidence of postoperative pulmonary complications, respiratory function (peak cough flow, pressure inspiratory maximum, peak expiratory flow, vital capacity (VC), % VC, %forced expiratory volume in one second (FEV1), FEV1/FVC, swallowing function (The Food Intake LEVEL Scale, repetitive saliva swallowing test), progression of post-operative rehabilitation (initiation days of sitting edge of bed, standing, and walking)

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	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	expiratory muscle training 2-4weeks (preoperative period) 25 breaths/set, > 1set/day
Interventions/Control_2	Normal treatment, 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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. age: patients who are older than 70 years old 2. gender: Male and Female 3. inpatients 4. before elective cardiovascular surgery 5. expiratory muscle training is permitted by the surgeon 6. patients who gained sufficient explanation for their participation in this study, and obtained written consent with the patient's free will with sufficient understanding
Key exclusion criteria	1. patients who are judged difficulty to implement respiratory muscle training due to cognitive impairment or neurological disorders, etc. 2. patients who cannot properly use the training equipment 3. patients who cannot intervene for more than two weeks before surgery 4. patients who cannot walk alone with assistance 5. patients who underwent surgery under general anesthesia within a month prior to surgery 6. patients who satisfied cancellation criteria at training implementation 7. patients with LVAD 8. patients planned for thoracic endovascular aortic repair 9. patients scheduled for abdominal aorta operation 10. patients planned for thoracic aorta operation 11. patients with history of pneumothorax
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Kozu
Organization	Nagasaki University
Division name	Department of Cardiopulmonary Rehabilitation Sciences, Nagasaki UniversityGraduate School of Biomedical Sciences
Zip code	852-8102
Address	1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, 852-8520, Japan
TEL	095-819-7963
Email	ryokozu@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Yui Middle name Last name Sakamoto
Organization	Nagasaki University
Division name	Department of Cardiopulmonary Rehabilitation Science, Nagasaki University Graduate School
Zip code	852-8102
Address	1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
TEL	095-819-7963
Homepage URL
Email	yui.tabuchi@gmail.com

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	self funding
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
Address	1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
Tel	0958197963
Email	yui.tabuchi@gmail.com

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	2017 Year 08 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
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	Terminated
Date of protocol fixation	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 01 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	2017 Year 07 Month 25 Day
Last modified on	2022 Year 08 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032071