UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028357 |
|---|---|
| Receipt number | 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 | 2022/08/05 09:48:27 |
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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
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
yui.tabuchi@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032071
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