Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03266510|
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Prehypertension Aging||Other: Inspiratory muscle strength training Other: Sham training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function|
|Actual Study Start Date :||November 25, 2017|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Inspiratory muscle strength training
Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be strong.
Other: Inspiratory muscle strength training
Subjects will perform inspiratory muscle strength training for 6 weeks.
Sham Comparator: Sham training
Using a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be weak.
Other: Sham training
Subjects will perform sham training for 6 weeks.
- Blood pressure [ Time Frame: 6 weeks ]Resting blood pressure
- Ambulatory blood pressure [ Time Frame: 6 weeks ]24-hour mean blood pressure
- Endothelium-dependent dilation [ Time Frame: 6 weeks ]Flow-mediated dilation
- Arterial stiffness [ Time Frame: 6 weeks ]Aortic pulse wave velocity
- Motor function [ Time Frame: 6 weeks ]NIH Toolbox motor test battery
- Cognitive function [ Time Frame: 6 weeks ]NIH Toolbox cognition test battery
- Systemic markers of oxidative stress [ Time Frame: 6 weeks ]Oxidized LDL levels in blood
- Endothelial cell markers of oxidative stress [ Time Frame: 6 weeks ]Nitrotyrosine levels in biopsied endothelial cells
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): NCT03266510
|Contact: Daniel H Craighead, PhDemail@example.com|
|United States, Colorado|
|Integrative Physiology of Aging Laboratory||Recruiting|
|Boulder, Colorado, United States, 80309|
|Contact: Melanie R Zigler, M.S. 303-492-2485 firstname.lastname@example.org|
|Principal Investigator:||Daniel H Craighead, PhD||University of Colorado, Boulder|
|Study Director:||Douglas R Seals, PhD||University of Colorado, Boulder|