- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463732
The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
March 16, 2021 updated by: National Taiwan University Hospital
Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness, which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system to transport and utilize oxygen.
Previous study showed that there is significant correlation between maximal oxygen consumption from cardiopulmonary exercise test and strength and endurance of lower extremities.
In people with sedentary lifestyle, they often limited by the lower limb muscle performance during cardiopulmonary exercise test.
Their breathing patterns are more irregular than athletes during cardiopulmonary exercise test.
However, there is no study comparing the activation pattern of respiratory muscles between these two groups.
Whether the breathing pattern in people with lower exercise capacity is less efficient under exertional activities still unknown.
The purpose of this study is to investigate the relationship between maximal oxygen consumption and inspiratory muscle activation pattern in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhongzheng Dist
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Taipei, Zhongzheng Dist, Taiwan, 100
- School and Graduate Institute of Physical Therapy of National Taiwan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy population is free from abnormal breathing pattern caused by disease.
Their terminals of cardiopulmonary exercise test are not limited by symptoms of disease.
Description
Inclusion Criteria:
- Healthy adults (age > 20 years old)
- Be able to cooperate with the measurements of this study
Exclusion Criteria:
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- history of syncope during exercise
- any musculoskeletal system disorder that unable to perform cardiopulmonary exercise test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy group
Subjects are above 20 years old.
Their condition is healthy with no history of inspiratory disease.
They can cooperate with the measurements of this study.
|
This is an observational study.
Loaded inspiratory muscle test is setting at 30% of maximal inspiratory pressure.
Subjects will perform only 15 breaths under this intensity to exam the performance of their inspiratory muscles.
Loaded inspiratory muscle test is not for training.
Cardiopulmonary exercise test is performed by using bicycle ergometer.
These two tests will be performed at least 1 week separately.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragm and Sternocleidomastoid muscle activation
Time Frame: during the loaded inspiratory muscle test condition; it would take about 3 minutes
|
Root mean square values
|
during the loaded inspiratory muscle test condition; it would take about 3 minutes
|
Maximal exercise capacity
Time Frame: during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
|
Maximal oxygen consumption
|
during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 29, 2020
First Submitted That Met QC Criteria
July 3, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202005050RINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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