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Trial record 15 of 20 for:    Recruiting, Not yet recruiting, Available Studies | "Prehypertension"

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 : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Hypertension Prehypertension Aging Other: Inspiratory muscle strength training Other: Sham training Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 weeks ]
    Resting blood pressure


Secondary Outcome Measures :
  1. Ambulatory blood pressure [ Time Frame: 6 weeks ]
    24-hour mean blood pressure

  2. Endothelium-dependent dilation [ Time Frame: 6 weeks ]
    Flow-mediated dilation

  3. Arterial stiffness [ Time Frame: 6 weeks ]
    Aortic pulse wave velocity

  4. Motor function [ Time Frame: 6 weeks ]
    NIH Toolbox motor test battery

  5. Cognitive function [ Time Frame: 6 weeks ]
    NIH Toolbox cognition test battery

  6. Systemic markers of oxidative stress [ Time Frame: 6 weeks ]
    Oxidized LDL levels in blood

  7. Endothelial cell markers of oxidative stress [ Time Frame: 6 weeks ]
    Nitrotyrosine levels in biopsied endothelial cells



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT03266510


Contacts
Contact: Daniel H Craighead, PhD 303-492-4568 daniel.craighead@colorado.edu

Locations
United States, Colorado
Integrative Physiology of Aging Laboratory Recruiting
Boulder, Colorado, United States, 80309
Contact: Melanie R Zigler, M.S.    303-492-2485    melanie.connell@colorado.edu   
Sponsors and Collaborators
Douglas Seals
Investigators
Principal Investigator: Daniel H Craighead, PhD University of Colorado, Boulder
Study Director: Douglas R Seals, PhD University of Colorado, Boulder

Additional Information:
Responsible Party: Douglas Seals, Professor of Distinction, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03266510     History of Changes
Other Study ID Numbers: 17-0151
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Douglas Seals, University of Colorado, Boulder:
Inspiratory muscle strength training

Additional relevant MeSH terms:
Respiratory Aspiration
Prehypertension
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases