HypertensionNCT03266510
Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
A study testing Inspiratory muscle strength training in people with Hypertension and Prehypertension, run by Douglas Seals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Prehypertension, Aging
- What is being tested?
- Inspiratory muscle strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2017to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Physiology of Aging Laboratory
Boulder, Colorado, 80309
About this study
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.
Read the 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.
- Conditions
- Hypertension, Prehypertension, Aging
- Being tested
- Inspiratory muscle strength training, Sham training
- Keywords
- Inspiratory muscle strength training
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength trainingOther
Subjects will perform inspiratory muscle strength training for 6 weeks.
Sham trainingOther
Subjects will perform sham training for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle strength training | Experimental | 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. Receives: Other: Inspiratory muscle strength training |
| Sham training | Sham comparator | 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. Receives: Other: Sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Resting blood pressure
Measured: 6 weeks
Secondary outcomes (7)
Ambulatory blood pressure
24-hour mean blood pressure
Measured: 6 weeks
Endothelium-dependent dilation
Flow-mediated dilation
Measured: 6 weeks
Arterial stiffness
Aortic pulse wave velocity
Measured: 6 weeks
Motor function
NIH Toolbox motor test battery
Measured: 6 weeks
Cognitive function
NIH Toolbox cognition test battery
Measured: 6 weeks
Systemic markers of oxidative stress
Oxidized LDL levels in blood
Measured: 6 weeks
Endothelial cell markers of oxidative stress
Nitrotyrosine levels in biopsied endothelial cells
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start25 Nov 2017
- Primary completion14 Apr 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Seals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Douglas Seals, University of Colorado, Boulder
- Investigators
- Daniel H Craighead, PhD, Principal investigator, University of Colorado, BoulderDouglas R Seals, PhD, Study director, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266510
- Sponsor's protocol ID
- 17-0151
- Status last verified
- May 2021
- First submitted
- 28 Aug 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craighead DH, Freeberg KA, Heinbockel TC, Rossman MJ, Jackman RA, McCarty NP, Jankowski LR, Nemkov T, Reisz JA, D'Alessandro A, Chonchol M, Bailey EF, Seals DR. Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. Med Sci Sports Exerc. 2024 Feb 1;56(2):266-276. doi: 10.1249/MSS.0000000000003291. Epub 2023 Sep 12.
PubMed 37707508Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.
PubMed 34184544
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
- ClinicalTrials.gov ID
- NCT03266510
- Acronym / sponsor ID
- 17-0151
- Conditions
- Hypertension, Prehypertension, Aging
- Keywords
- Inspiratory muscle strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Douglas SealsUniversity, hospital or other
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle strength training | Experimental | Other: Inspiratory muscle strength trainingUsing 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. |
| Sham training | Sham comparator | Other: Sham trainingUsing 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. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength trainingSubjects will perform inspiratory muscle strength training for 6 weeks. | Other | Inspiratory muscle strength training |
| Sham trainingSubjects will perform sham training for 6 weeks. | Other | Sham training |
Primary outcome
Blood pressure
Time frame: 6 weeks
Resting blood pressure
7 secondary outcomes
Ambulatory blood pressure
Time frame: 6 weeks
Endothelium-dependent dilation
Time frame: 6 weeks
Arterial stiffness
Time frame: 6 weeks
Motor function
Time frame: 6 weeks
Cognitive function
Time frame: 6 weeks
Systemic markers of oxidative stress
Time frame: 6 weeks
Endothelial cell markers of oxidative stress
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 37707508Craighead DH, Freeberg KA, Heinbockel TC, Rossman MJ, Jackman RA, McCarty NP, Jankowski LR, Nemkov T, Reisz JA, D'Alessandro A, Chonchol M, Bailey EF, Seals DR. Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. Med Sci Sports Exerc. 2024 Feb 1;56(2):266-276. doi: 10.1249/MSS.0000000000003291. Epub 2023 Sep 12.
- Derived from this study: PubMed 34184544Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.
- Description of our Research LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H Craighead, PhD principal investigator
University of Colorado, Boulder
Douglas R Seals, PhD study director
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle strength training in people with Hypertension and Prehypertension, run by Douglas Seals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.