Inspiratory Muscle Training vs Aerobic Exercise for High Blood Pressure

Overseen By Narissa P McCarty, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Disqualifiers: Uncontrolled hypertension, Current smoker, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether inspiratory muscle training (high-resistance breathing exercises using a device) or aerobic exercise like brisk walking is more effective at lowering blood pressure and improving heart health in postmenopausal women. Researchers seek to understand how these treatments impact blood pressure and blood vessel function, and how they might reduce stress on the heart. This study is ideal for postmenopausal women over 50 with a systolic blood pressure of 120 mmHg or higher who are not on hormone therapy. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance heart health strategies for women.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, you must not have changed your blood pressure medications or other medications in the past 3 months and should be willing to maintain your current medication regimen throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that high-resistance inspiratory muscle strength training (IMST) is generally safe and manageable for most people. Studies have found that IMST effectively lowers blood pressure and improves blood vessel health in middle-aged adults. Many people find it easy to incorporate into their daily routine, and no serious side effects have been widely reported in available studies.

In contrast, aerobic exercise is a well-established method for managing high blood pressure. Health organizations recommend it as part of a healthy lifestyle. Aerobic exercise is safe for most people and helps lower blood pressure without major risks.

Both treatments have demonstrated safety in existing research, making them promising options for managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional high blood pressure treatments such as medications or lifestyle changes like diet and standard exercise, high-resistance inspiratory muscle strength training offers a unique approach. This method involves using a handheld device to perform deep breathing exercises, which strengthens the muscles used for inhalation. Researchers are excited about this because it targets respiratory muscles directly, potentially improving blood pressure control without the need for conventional medication. Additionally, this technique could offer a non-invasive and accessible option for people seeking an alternative or supplementary method to manage their blood pressure effectively.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare high-resistance inspiratory muscle strength training (IMST) with aerobic exercise for lowering blood pressure. Research has shown that IMST can reduce blood pressure, with earlier studies indicating a reduction of about 9 points in the systolic reading for adults with elevated levels. This decrease is comparable to or even better than results from regular aerobic exercise. Additionally, IMST has shown promise in improving vascular function in postmenopausal women, which is crucial for heart health. While aerobic exercise also lowers blood pressure, typically by about 3 to 4 points, it often requires more time and effort. IMST might offer a quicker alternative with similar benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Douglas R Seals, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Ability to provide informed consent

Exclusion Criteria

You have a problem with drinking too much alcohol or being dependent on it.

I do not have uncontrolled high blood pressure.

You regularly do intense aerobic exercise more than 4 times a week for at least 30 minutes each time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Baseline Testing

Participants undergo baseline testing for casual SBP, 24-hour ambulatory SBP, and endothelial function, including innovative mechanistic probes.

1 week

Multiple visits (in-person)

Treatment

Participants are randomized to either high-resistance inspiratory muscle strength training (IMST) or aerobic exercise (AE) for 3 months.

12 weeks

1 supervised visit, multiple unsupervised sessions (home-based)

Post-Testing

Reassessment of all outcomes and subject characteristic measures after completion of the intervention.

1 week

Multiple visits (in-person)

Follow-up

Participants cease training for 6 weeks and return for follow-up testing to determine the persistent effects of IMST.

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• High-resistance inspiratory muscle strength training

Trial Overview 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.

How Is the Trial Designed?

Group I: High-resistance inspiratory muscle strength training Experimental Treatment 1 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 exercise Active Control 1 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.

High-resistance inspiratory muscle strength training is already approved in United States, European Union for the following indications:

Approved in United States as High-Resistance Inspiratory Muscle Strength Training for:

• Lowering blood pressure
• Improving endothelial function

Approved in European Union as High-Resistance Inspiratory Muscle Strength Training for:

• Respiratory rehabilitation
• Improving lung function

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Published Research Related to This Trial

Inspiratory muscle training (IMT) significantly reduces systolic blood pressure (SBP) by an average of 12.55 mmHg and diastolic blood pressure (DBP) by 4.77 mmHg in patients with hypertension, based on a meta-analysis of 8 randomized controlled trials involving 215 patients.

Low-intensity IMT is particularly effective, showing greater reductions in both SBP and DBP compared to medium-high-intensity IMT, suggesting it could be a valuable auxiliary treatment for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training in patients with hypertension: a meta-analysis. Zheng, S., Zhang, Q., Li, S., et al.[2023]

High-resistance inspiratory muscle strength training (IMST) significantly lowers systolic blood pressure (SBP) by 9 mmHg and diastolic blood pressure (DBP) by 4 mmHg in adults over 6 weeks, with effects noticeable as early as week 2.

IMST also improves inspiratory muscle strength, as indicated by increased maximal inspiratory pressure (PIMAX), and is effective across a wide range of adult ages and health statuses, making it a promising intervention for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. Craighead, DH., Tavoian, D., Freeberg, KA., et al.[2023]

Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

High-resistance inspiratory muscle strength training (IMST) over 6 weeks significantly reduced systolic blood pressure in midlife and older adults, with effects lasting for at least 6 weeks after the training ended.

IMST also improved endothelial function, as shown by a 45% increase in brachial artery flow-mediated dilation, indicating its potential as a safe and effective intervention for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Craighead, DH., Heinbockel, TC., Freeberg, KA., et al.[2022]

Inspiratory muscle training (IMT) significantly improves respiratory muscle strength, as shown by increases in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), in a systematic review of four studies involving 80 patients with pulmonary hypertension.

IMT also enhances exercise capacity, evidenced by a notable increase in the 6-minute walk distance (6MWD), but does not show significant improvements in pulmonary function or quality of life, indicating that while IMT is beneficial, more research is needed to fully understand its effects on dyspnea and fatigue in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of inspiratory muscle training in patients with pulmonary hypertension: A systematic review and meta-analysis. Luo, Z., Qian, H., Zhang, X., et al.[2022]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength and functional capacity in 29 patients with pulmonary arterial hypertension (PAH) over a 6-week program, leading to better performance in activities like walking.

Patients undergoing IMT reported reduced fatigue and dyspnea, indicating that this training is a safe and effective treatment option for enhancing quality of life in PAH patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in pulmonary arterial hypertension. Saglam, M., Arikan, H., Vardar-Yagli, N., et al.[2015]

High-intensity inspiratory muscle training (IMT) significantly improved inspiratory muscle strength (IMS), inspiratory muscle endurance (IME), and peak power in recreational cyclists over 11 weeks, compared to a sham group.

However, the benefits of high-intensity IMT were not superior to those achieved with moderate-intensity IMT, as both training intensities led to similar improvements in performance without increasing oxygen uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate- and High-Intensity Inspiratory Muscle Training Equally Improves Inspiratory Muscle Strength and Endurance-A Double-Blind Randomized Controlled Trial. Rehder-Santos, P., Abreu, RM., Signini, ÉF., et al.[2022]

Inspiratory muscle training (IMT) significantly improves balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11926784/

Effect of aerobic exercise on blood pressure: a meta-analysis ... Aerobic exercise was associated with a significant reduction in mean systolic and diastolic blood pressure (-3.84 mm Hg [95% CI, -4.97 to -2.72 mm Hg] and -2.58 ...

2. bjsm.bmj.com bjsm.bmj.com/content/57/20/1317

Exercise training and resting blood pressure: a large-scale ... Overall, isometric exercise training is the most effective mode in reducing both systolic and diastolic blood pressure. These findings provide a comprehensive ...

3. nature.com nature.com/articles/s41440-024-01774-9

Two-tiered aerobic exercise program in hypertension 30 min/week of aerobic exercise reduced systolic blood pressure by 1.78 mmHg and reduced diastolic blood pressure by 1.23 mmHg.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1548584/full

Aerobic activity significantly reduces blood pressure ... Pooled results showed the effectiveness of the aerobic activity intervention in lowering blood pressure, with a − 14.03 mmHg reduction in SBP ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.018487

Exercise Reduces Ambulatory Blood Pressure in Patients ... The present findings suggest that exercise training results in significant reductions of all ABP measures (ie, 24‐hour, daytime, and nighttime ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4369613/

Evidence for exercise training in the management of ... Moderate intensity aerobic exercise has been proven to prevent hypertension and to help in the management of stage 1 hypertension. Dynamic resistance exercises, ...

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Physical Activity as a Critical Component of First-Line ... The blood pressure and cholesterol guidelines recommend treatment with similar, although not identical, physical activity prescriptions.

8. heart.org heart.org/en/healthy-living/fitness/fitness-basics/aha-recs-for-physical-activity-in-adults

AHA Physical Activity Recommendations ... Get at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination ...

9. mayoclinic.org mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/high-blood-pressure/art-20045206

A drug-free approach to lowering high blood pressure How much exercise do you need? Try to get at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity a week. You could do ...

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Aerobic, Resistance, and Isometric Exercise to Reduce Blood ... Aerobic exercise showed more benefits than other types of exercise to improve BPV, especially on the diastolic BPV when it was compared with no exercise.