UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000028357
Receipt No. R000032071
Scientific Title Effect of expiratory muscle training for the elderly patients before cardiovascular surgery on postoperative pressure expiratory maximum.
Date of disclosure of the study information 2017/08/01
Last modified on 2019/07/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Suspended
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
2019 Year 07 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.