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 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.

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 inspiratory muscle training safe for humans?

Inspiratory muscle training (IMST) is generally safe and well-tolerated in humans, with studies showing high adherence and no significant safety concerns reported. It has been used in various populations, including older adults and those with high blood pressure, without adverse effects. ^{1 2 3 4 5}

How does high-resistance inspiratory muscle strength training differ from other treatments for high blood pressure?

High-resistance inspiratory muscle strength training (IMST) is unique because it involves breathing exercises that strengthen the muscles used for inhaling, which can lower blood pressure by improving respiratory muscle strength. Unlike traditional treatments like medication, IMST is a physical therapy that can be done at home using a handheld device, making it a non-drug option for managing high blood pressure. ^{1 3 4 5 6}

What data supports the effectiveness of this treatment for high blood pressure?

Research shows that inspiratory muscle training (IMT) can improve respiratory muscle strength and reduce symptoms like fatigue and shortness of breath, which may indirectly benefit people with high blood pressure by enhancing overall exercise capacity and quality of life. ^{4 5 6 7 8}

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in pulmonary arterial hypertension. [2015]

2. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

3. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training in patients with hypertension: a meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of inspiratory muscle training in patients with pulmonary hypertension: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. [2023]

7. England 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. [2022]

8. United States 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. [2022]