What side effects are associated with this type of intervention?

Common treatments for high blood pressure include lifestyle interventions like aerobic exercise and resistance training, as well as pharmacological treatments such as ACE inhibitors, beta-blockers, diuretics, and calcium channel blockers. Aerobic exercise and resistance training, including IMST, are generally safe but can cause muscle soreness and fatigue. Pharmacological treatments may have side effects such as dizziness, headaches, fatigue, gastrointestinal issues, and in some cases, more severe reactions like kidney dysfunction or electrolyte imbalances. IMST specifically aims to reduce oxidative stress and increase nitric oxide bioavailability, which can improve endothelial function and lower blood pressure without the systemic side effects associated with medications.

What prior FDA approvals exist?

Several FDA-approved treatments for high blood pressure focus on mechanisms that decrease oxidative stress and increase nitric oxide bioavailability. Angiotensin-converting enzyme inhibitors (ACE inhibitors) like quinapril and angiotensin II receptor blockers (ARBs) such as olmesartan medoxomil are known to improve endothelial function by increasing nitric oxide production and reducing oxidative stress. These medications help lower blood pressure and protect cardiovascular health by enhancing the bioavailability of nitric oxide, which is crucial for vascular relaxation and reducing oxidative damage.

What other types of research exist?

Promising novel alternatives to High-Resistance Inspiratory Muscle Strength Training (IMST) for high blood pressure patients include dietary nitrate supplementation, such as beetroot juice, which has been shown to improve exercise tolerance and potentially lower blood pressure by increasing nitric oxide bioavailability. Another alternative could be the use of antioxidants or other supplements that target oxidative stress, although more research is needed to confirm their efficacy.

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Behavioural Intervention

Inspiratory Muscle Training vs Aerobic Exercise for High Blood Pressure

N/A

Recruiting

Led By Douglas R Seals, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen

Postmenopausal women (>12 months of amenorrhea)

Must not have

History of uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)

Younger than age 50 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Summary

This trial is testing a breathing exercise called high-resistance inspiratory muscle strength training (IMST) for postmenopausal women aged 50 and older with high blood pressure. IMST involves breathing in against resistance for a short period each day. It aims to lower blood pressure and improve blood vessel function by reducing harmful molecules and increasing helpful ones. High-resistance inspiratory muscle strength training (IMST) is a novel, time-efficient physical training modality.

Who is the study for?

This trial is for postmenopausal women aged 50 or older with high blood pressure (systolic BP ≥120 mmHg). Participants should not be on hormone therapy, have a BMI under 40, and must not have had significant weight changes or medication adjustments recently. They shouldn't smoke, abuse alcohol, or engage in regular intense exercise.

What is being tested?

The study compares the effects of high-resistance inspiratory muscle strength training (IMST) versus standard aerobic exercise like brisk walking on lowering blood pressure and improving vascular health in postmenopausal women over three months.

What are the potential side effects?

Potential side effects are not explicitly listed but may include muscle fatigue from IMST and typical exercise-related risks such as joint strain from brisk walking. The safety profile will likely be clarified during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't changed my blood pressure or any other medications in the last 3 months and am willing to keep them the same.

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I am a woman who has not had a period for over 12 months.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled high blood pressure.

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I am under 50 years old.

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I experienced menopause before the age of 45.

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I have had a hysterectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in casual systolic and diastolic blood pressure at 3 months

Secondary study objectives

Change from baseline endothelial function at 3 months

Change from baseline in ambulatory systolic and diastolic blood pressure at 3 months

Other study objectives

Adherence to the intervention

Change from baseline in endothelial cell nitric oxide production at 3 months

Change from baseline in endothelial cell oxidative stress at 3 months

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-resistance inspiratory muscle strength trainingExperimental Treatment1 Intervention

Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for three months.

Group II: Aerobic exerciseActive Control1 Intervention

Participants will walk for 25 minutes a day, six days a week, for three months at a target heart rate of 40-60% heart rate reserve. Heart rate will be monitored with a heart rate monitor.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure, such as High-Resistance Inspiratory Muscle Strength Training (IMST), work by reducing oxidative stress and increasing nitric oxide bioavailability. These mechanisms help relax blood vessels, improve endothelial function, and reduce vascular resistance, which are essential for lowering blood pressure. This is particularly important for high blood pressure patients as it helps mitigate the risk of cardiovascular diseases and improves overall vascular health.

Resistance training to reduce resting blood pressure and increase muscle strength in users and non-users of anti-hypertensive medication: A meta-analysis.[Respiratory physiotherapy in post-acute COVID-19 adult patients: Systematic review of literature].Molecular Regulation of Skeletal Muscle Growth and Organelle Biosynthesis: Practical Recommendations for Exercise Training.