HealthyNCT04463732
The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Loaded inspiratory muscle test and cardiopulmonary exercise test
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy adults (age > 20 years old)
- Be able to cooperate with the measurements of this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, Zhongzheng Dist, 100
About this study
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.
- Conditions
- Healthy
- Being tested
- Loaded inspiratory muscle test and cardiopulmonary exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded inspiratory muscle test and cardiopulmonary exercise testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Loaded inspiratory muscle test and cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm and Sternocleidomastoid muscle activation
Root mean square values
Measured: during the loaded inspiratory muscle test condition; it would take about 3 minutes
Maximal exercise capacity
Maximal oxygen consumption
Measured: during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, PhD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463732
- Sponsor's protocol ID
- 202005050RINA
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
- ClinicalTrials.gov ID
- NCT04463732
- Acronym / sponsor ID
- 202005050RINA
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Other: Loaded inspiratory muscle test and cardiopulmonary exercise testSubjects are above 20 years old. Their condition is healthy with no history of inspiratory disease. They can cooperate with the measurements of this study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Healthy adults (age > 20 years old)
- Be able to cooperate with the measurements of this study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loaded inspiratory muscle test and cardiopulmonary exercise testThis 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. | Other | Healthy group |
Primary outcome
Diaphragm and Sternocleidomastoid muscle activation
Time frame: during the loaded inspiratory muscle test condition; it would take about 3 minutes
Root mean square values
Maximal exercise capacity
Time frame: during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
Maximal oxygen consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Ying Wang, PhD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm and Sternocleidomastoid muscle activation (time frame: during the loaded inspiratory muscle test condition; it would take about 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.