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Respiratory Muscle Contribution to Blood Pressure During Exercise

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ClinicalTrials.gov Identifier: NCT03514823
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Thomas P. Olson, M.S., Ph.D., Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Muscle Blood Pressure Exercise Capacity Sympathetic Nerve Activity Other: Inspiratory Muscle Training (IMT) Other: No Inspiratory Muscle Training (IMT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Respiratory Muscle Contribution to Blood Pressure During Exercise in Healthy Humans
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IMT Group Other: Inspiratory Muscle Training (IMT)
Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.
Sham Comparator: No IMT Group Other: No Inspiratory Muscle Training (IMT)
No inspiratory muscle training.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514823


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Josh Smith, PhD    507-422-0264    smith.joshua1@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Thomas P Olson Mayo Clinic
More Information
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Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

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Responsible Party: Thomas P. Olson, M.S., Ph.D., Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03514823    
Other Study ID Numbers: 17-011100
5R01HL126638-03 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No