NCT04463732

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 18, 2021

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 29, 2020

Last Update Submit

March 16, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diaphragm and Sternocleidomastoid muscle activation

    Root mean square values

    during the loaded inspiratory muscle test condition; it would take about 3 minutes

  • Maximal exercise capacity

    Maximal oxygen consumption

    during the cardiopulmonary exercise test; it would take about 12 to 15 minutes

Study Arms (1)

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.

Other: Loaded inspiratory muscle test and cardiopulmonary exercise test

Interventions

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.

Healthy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Healthy adults (age \> 20 years old)
  • Be able to cooperate with the measurements of this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy of National Taiwan University

Taipei, Zhongzheng Dist, 100, Taiwan

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Li-Ying Wang, PhD

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 9, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 18, 2021

Record last verified: 2020-06

Locations