- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514823
Respiratory Muscle Contribution to Blood Pressure During Exercise
July 22, 2021 updated by: Thomas P. Olson, M.S., Ph.D., Mayo Clinic
Respiratory Muscle Contribution to Blood Pressure During Exercise in Healthy Humans
The investigators seek to understand how reflexes from the breathing muscles influence blood pressure during exercise.
Furthermore, the investigators are determining if increasing breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle contribution to blood pressure during exercise.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
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
-
-
Minnesota
-
Rochester, Minnesota, United States, 55901
- Mayo Clinic
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMT Group
|
Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.
|
Sham Comparator: No IMT Group
|
No inspiratory muscle training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 max test
Time Frame: Through study completion, an average of one year.
|
Using a MedGraphics metabolic cart, the investigators will measure the maximum amount of oxygen that an individual can utilize during exercise.
During this test the subject will be asked to exercise to his/her max capacity on a recumbent bicycle while breathing through a mouth piece that is hooked into the MedGraphics computer software.
|
Through study completion, an average of one year.
|
Blood Pressure
Time Frame: Through study completion, an average of one year.
|
Blood pressure will be taken every few minutes during exercise testing using a standard blood pressure cuff to monitor changes in blood pressure.
|
Through study completion, an average of one year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas P Olson, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
August 1, 2018
Primary Completion (Actual)
September 25, 2019
Study Completion (Actual)
September 25, 2019
Study Registration Dates
First Submitted
April 18, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 2, 2018
Study Record Updates
Last Update Posted (Actual)
July 26, 2021
Last Update Submitted That Met QC Criteria
July 22, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 17-011100
- 5R01HL126638-03 (U.S. NIH Grant/Contract)
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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