UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053044 |
|---|---|
| Receipt number | R000060519 |
| Scientific Title | The Impact of Respiratory Muscle Training on Ventilatory Function and |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/09 17:28:13 |
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Basic information
Public title
Effect of inspiratory muscle-loaded exercise training on ventilatory response and intercostal muscle deoxygenation during incremental cycling exercise
Acronym
Inspiratory muscle-loaded exercise training Impact study
Scientific Title
The Impact of Respiratory Muscle Training on Ventilatory Function and
Scientific Title:Acronym
Respiratory Muscle Training Ventilation Effect Study
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether the training that loads the inspiratory muscles during exercise affects exercise capacity, respiratory response during exercise, tissue oxygenation levels in the respiratory muscles, and respiratory regulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory metabolic response, as determined by exhaled gas analysis during incremental load exercise, before and after a 4-week exercise training regimen using a bicycle ergometer at 60% of maximal oxygen uptake.
Key secondary outcomes
Respiratory muscle strength, endurance, and function measured using an autospirometry.
Oxygenated and deoxygenated hemoglobin level in the intercostal muscles, assessed using near-infrared spectroscopy.
ypoxic ventilatory chemosensitivity evaluated through the rebreathing method.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will undergo a 4-week intervention, consisting of bicycle ergometer exercise sessions four times per week. Each session will last 20 minutes, performed at 60% of maximal intensity. During the exercise, participants will breathe through a PowerBreathe device set to 50% of their maximal inspiratory load.
Interventions/Control_2
Participants will undergo a 4-week intervention, consisting of bicycle ergometer exercise sessions four times per week. Each session will last 20 minutes, performed at 60% of maximal intensity.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Healthy, exercise-trained adult males.
Key exclusion criteria
Exclusion criteria include individuals with a history of respiratory or cardiovascular diseases, and smokers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogawa |
Organization
Osaka Kyoiku University
Division name
Division of Art, Music and Physical Education
Zip code
582-8582
Address
Asahigaoka 4-698-1, Kashiwara city Osaka, Japan
TEL
072(978)3751
ogawat@cc.osaka-kyoiku.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogawa |
Organization
Osaka Kyoiku University
Division name
Division of Art, Music and Physical Education
Zip code
582-8582
Address
Asahigaoka 4-698-1, Kashiwara city Osaka, Japan
TEL
072(978)3751
Homepage URL
ogawat@cc.osaka-kyoiku.ac.jp
Sponsor or person
Institute
Osaka Kyoiku University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kyoiku University
Address
Asahigaoka 4-698-1, Kashiwara city Osaka, Japan
Tel
072(978)3217
kenkyo@bur.osaka-kyoiku.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
| 2023 | Year | 12 | Month | 12 | 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
21
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The paper is currently under submission and remains unpublished.
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060519
