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Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

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ClinicalTrials.gov Identifier: NCT03266510
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE August 30, 2017
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE November 25, 2017
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
Blood pressure [ Time Frame: 6 weeks ]
Resting blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03266510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
Official Title  ICMJE Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
Brief Summary The purpose of this study is to assess the efficacy of inspiratory muscle strength training for lowering blood pressure and improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults with elevated systolic blood pressure.
Detailed Description Over, the proposed research project has the long-term potential to influence clinical practice by establishing a novel lifestyle intervention for treating multiple domains of age- and hypertension-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Prehypertension
  • Aging
Intervention  ICMJE
  • Other: Inspiratory muscle strength training
    Subjects will perform inspiratory muscle strength training for 6 weeks.
  • Other: Sham training
    Subjects will perform sham training for 6 weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Inspiratory muscle strength training
  • 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.
    Intervention: Other: Sham training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2017)
48
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to provide informed consent
  • Willing to accept random assignment to condition
  • Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
  • Resting systolic blood pressure 120-159 mmHg
  • Resting diastolic blood pressure <100 mmHg
  • Subjects taking anti-hypertensive medications will be included provided they meet the other inclusion criteria, including elevated systolic blood pressure. These medications will not be withheld prior to experimental protocols.
  • Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)

Exclusion Criteria:

  • Current smoking
  • Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive function [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia, or other brain diseases of aging]), except hypertension
  • Postmenopausal <1 year
  • Scoring <21 on the mini-mental state examination
  • Moderate or sever peripheral artery disease (ankle-brachial index 0.7)
  • Taking a medication that your doctor deems unsafe to hold for >1 week
  • A graded exercise test will be performed by all subjects. If there is physician concern or an adverse event, the subject will not participate in the study.
  • No weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniel H Craighead, PhD 303-492-4568 daniel.craighead@colorado.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03266510
Other Study ID Numbers  ICMJE 17-0151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Douglas Seals, University of Colorado, Boulder
Study Sponsor  ICMJE Douglas Seals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel H Craighead, PhD University of Colorado, Boulder
Study Director: Douglas R Seals, PhD University of Colorado, Boulder
PRS Account University of Colorado, Boulder
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP