Inspiratory Muscle Strength Training for High Blood Pressure

Overseen By Narissa McCarty, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Boulder

Disqualifiers: Uncontrolled hypertension, Current smoker, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to reduce high blood pressure, a major risk factor for serious health issues like heart disease and stroke. Participants will either use a handheld device for breathing exercises (inspiratory muscle strength training) or engage in brisk walking for three months. The researchers aim to determine if these activities can lower blood pressure and improve functions like blood flow and brain health. Individuals aged 50 and older with high blood pressure (120 mmHg or higher) who do not regularly engage in vigorous exercise might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore non-drug interventions for managing high blood pressure.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, participants must maintain their current medication regimen without changes during the study.

What prior data suggests that this inspiratory muscle strength training is safe for lowering high blood pressure?

Research has shown that inspiratory muscle strength training (IMST) is generally safe for people. Studies indicate that IMST is easy to handle and carries a low risk of side effects. In one study, older adults who used IMST experienced improved blood pressure and heart health without major problems. Another study found that IMST enhanced blood pressure and blood vessel function, with participants adhering well to the program. Overall, evidence suggests that IMST is a safe and promising method for managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle strength training for high blood pressure because it introduces a novel approach to managing the condition using a simple, non-pharmacological method. Unlike standard treatments that often rely on medications like ACE inhibitors or beta-blockers, this technique uses a handheld device to strengthen breathing muscles, potentially lowering blood pressure naturally. The convenience of at-home use and the absence of medication side effects make it an appealing alternative. Additionally, brisk walking, another treatment in the trial, offers a refreshing, active lifestyle change by incorporating moderate aerobic exercise, which is already known to support cardiovascular health.

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

Research has shown that a breathing exercise called inspiratory muscle strength training (IMST), which participants in this trial may receive, can help lower blood pressure. Studies have found that IMST can reduce systolic blood pressure by about 9 points in adults with high blood pressure. This reduction is comparable to, or even better than, results from longer exercises like running. IMST also improves blood vessel function, likely by reducing damage from harmful molecules. This makes IMST a promising and quick method for managing high blood pressure. Another group in this trial will engage in brisk walking, serving as an active comparator. ^{2 4 6 7 8}

Who Is on the Research Team?

Daniel H Craighead, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

Adults aged 50 or older with high blood pressure (systolic BP of at least 120 mmHg), a BMI under 40, and stable weight are eligible for this trial. They must be non-smokers, not on changing medication regimens, able to consent, and have no history of uncontrolled hypertension or regular vigorous exercise.

Inclusion Criteria

Your blood pressure when you are relaxed is 120 mmHg or higher.

I am healthy except for high blood pressure.

I haven't changed my medications or doses in the last 3 months and will keep them the same.

Exclusion Criteria

I am under 50 years old.

Your blood pressure doesn't react normally during exercise, or it becomes very high during exercise.

You do intense aerobic exercise more than four 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

Baseline Testing

Subjects undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP, endothelial function, arterial stiffness, cognitive function, and cerebrovascular function.

1-2 weeks

1 visit (in-person)

Treatment

Participants perform either 3-months of high-resistance IMST or brisk walking. Subjects train 6 days/week with one training session supervised in the laboratory and the other 5 performed unsupervised at home.

12 weeks

12 visits (1 per week, in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including redo of all baseline tests to assess training-induced changes.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brisk walking
• Inspiratory muscle strength training

Trial Overview The trial is testing whether a time-efficient breathing exercise called Inspiratory Muscle Strength Training (IMST) can lower systolic blood pressure more effectively than brisk walking. Participants will do one of these activities for three months to see if there's an improvement in blood pressure and vascular health.

How Is the Trial Designed?

Group I: 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: Brisk walking 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.

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Published Research Related to This Trial

This study will evaluate the long-term effects of high-resistance inspiratory muscle strength training (IMST) on lowering blood pressure in middle-aged and older adults with obstructive sleep apnea (OSA) over a 24-week period, involving 92 to 122 participants.

The primary outcome is casual systolic blood pressure, with secondary outcomes including 24-hour blood pressure and vascular function, aiming to establish the efficacy of IMST as a practical exercise intervention for improving cardiovascular health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six Months of Inspiratory Muscle Training to Lower Blood Pressure and Improve Endothelial Function in Middle-Aged and Older Adults With Above-Normal Blood Pressure and Obstructive Sleep Apnea: Protocol for the CHART Clinical Trial. Tavoian, D., Ramos-Barrera, LE., Craighead, DH., 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]

Inspiratory muscle training (IMT) significantly improved functional capacity, balance, respiratory and peripheral muscle strength, as well as reduced depression and dyspnea in heart failure patients over a 6-week period, compared to a control group.

The study involved 30 heart failure patients and demonstrated that IMT should be integrated into pulmonary rehabilitation programs due to its positive effects on various health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training in patients with heart failure. Bosnak-Guclu, M., Arikan, H., Savci, S., et al.[2011]

Inspiratory muscle training (IMT) significantly improves key health metrics in patients with chronic heart failure (CHF), including peak VO2, six-minute walk distance, quality of life, maximal inspiratory pressure, and ventilatory efficiency, based on a meta-analysis of 11 studies with 287 participants.

IMT offers a viable alternative to traditional exercise training for severely deconditioned CHF patients, showing improvements comparable to those achieved through conventional exercise, which may help these patients transition to more intensive exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training in chronic heart failure patients: a systematic review and meta-analysis. Smart, NA., Giallauria, F., Dieberg, G.[2018]

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]

A 6-week program of high-resistance, low-volume inspiratory muscle strength training (IMST) significantly improved respiratory endurance in ten healthy young adults, increasing the time to exhaustion from 362 seconds to 664 seconds.

IMST also led to reductions in resting blood pressure and heart rate responses during high respiratory workloads, suggesting potential benefits for cardiovascular health and athletic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A short course of high-resistance, low-volume breathing exercise extends respiratory endurance and blunts cardiovascular responsiveness to constant load respiratory testing in healthy young adults. DeLucia, CM., Tavoian, D., Debonis, DR., 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205163/

Inspiratory muscle strength training lowers blood pressure and ... Previous work has shown lowered casual blood pressure after just 6 wk of inspiratory muscle strength training (IMST), suggesting IMST as a potential therapeutic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061950/

High-resistance inspiratory muscle strength training High-resistance IMST reduces muscle sympathetic nerve activity, circulating catecholamines, and blood pressure in older adults with obstructive ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.020980

Time‐Efficient Inspiratory Muscle Strength Training Lowers ... Twenty‐four hour systolic blood pressure was lower after IMST versus sham training (P=0.01). Brachial artery flow‐mediated dilation improved ≈45 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05000515

Inspiratory Muscle Strength Training for Lowering Blood ... Study Overview: This is a randomized, single-blind, parallel-design, clinical trial assessing the efficacy of high-resistance inspiratory muscle strength ...

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1113509/full

Effects of inspiratory muscle training in patients with ... It (15) shows that IMT has no obvious effects on the BP of patients with hypertension, and slow breathing is more effective than IMT in lowering ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9150656/

Time-efficient, high-resistance inspiratory muscle strength ... Inspiratory muscle strength training lowers blood pressure and sympathetic activity in older adults with OSA: a randomized controlled pilot trial. J. Appl ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06931886

NCT06931886 | Pulmonary Hypertension Inspiratory Training This study is examining the effects of six weeks of inspiratory muscle strength training (IMST) on outcomes related to pulmonary hypertension.

8. kjsm.org kjsm.org/journal/view.html?volume=43&number=2&spage=78

Is Inspiratory Muscle Training an Emerging Strategy for ... Abstract: Aerobic exercise is a well-known nonpharmacological strategy for managing blood pressure (BP) in hypertensive patients.