UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039000 |
|---|---|
| Receipt number | R000044474 |
| Scientific Title | Inspection of the effectiveness of expiratory muscle training for healthy middle-aged adults |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2023/01/03 20:27:09 |
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Basic information
Public title
Inspection of the effectiveness of expiratory muscle training for healthy middle-aged adults
Acronym
Inspection of the effectiveness of expiratory muscle training for healthy middle-aged adults
Scientific Title
Inspection of the effectiveness of expiratory muscle training for healthy middle-aged adults
Scientific Title:Acronym
Inspection of the effectiveness of expiratory muscle training for healthy middle-aged adults
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was the effect and presence of adverse events of expiratory muscle training for healthy middle-aged adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum expiratory mouth pressure(PEmax)
Key secondary outcomes
vital capacity(VC), forced vital capacity(FVC), Foced expiratory volume in 1 second(FEV1), FEV1/FVC, maximum inspiratory mouth pressure(PImax), cough peak flow(CPF), Training status, Safety(blood pressure, changes in subjective symptoms)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects of the intervention group will perform expiratory muscle training and inspiratory muscle training for 7 days a week for 2 weeks.Expiratory muscle training is performed twice a day at 75% of PEmax 30 times a day. Inspiratory muscle training is performed twice a day at 40% of PImax 30 times a day.
Interventions/Control_2
Subjects of the control group will perform inspiratory muscle training for 7 days a week for 2 weeks.Inspiratory muscle training is performed twice a day at 40% of PImax 30 times a day.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Person who conducted research explanation and obtained written consent for exercise
Key exclusion criteria
1) In the case where the attending physician decides that it is inappropriate
2) Cases where 8week intervention is impossible
3) Cases scheduled for surgery within the study period
4) Cases with a history of pneumothorax
5) Cases that have developed cancer
6) Cases that have developed asthma
Target sample size
17
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
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 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
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Medical Association
Organization
Division
Category of Funding Organization
Other
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
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 | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Data collection was not completed due to the COVID-19 pandemic.
Publication of results
Unpublished
Result
URL related to results and publications
Data collection was not completed due to the COVID-19 pandemic.
Number of participants that the trial has enrolled
12
Results
Short-term EMT in healthy middle-aged and older adults improved respiratory muscle strength (P<0.05) and could be performed without adverse events.
Results date posted
| 2022 | Year | 06 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data collection was not completed due to the COVID-19 pandemic.
Date of the first journal publication of results
Baseline Characteristics
Fourteen participants (12 in the intervention group and 2 in the control group) were aged 49.6(6.8) years, and 9 were male.
Participant flow
Fifteen participants were recruited, and one dropped out, for a total of 14 participants in the analysis.
Adverse events
None.
Outcome measures
Only results for the intervention group are shown.
PEmax increased from 134.3(39.0)cmH2O to 158.4(51.4)cmH2O(p<0.05).
PImax increased from 87.8(30.2)cmH2O to 102.4(33.5)cmH2O(p<0.05).
CPF did not change from 442.4(106.1)cmH2O to 449.9(127.2)cmH2O(p>0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044474
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