Inspiratory Muscle Strength Training for High Blood Pressure

Overseen By Hannah Westerberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Cardiovascular disease, Abdominal surgery, Asthma, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a breathing exercise called Inspiratory Muscle Strength Training (IMST) to assess its effects on individuals with high blood pressure. Participants will use a device to take a set number of breaths daily, with groups performing either 15, 30, or 45 breaths for six weeks. The trial aims to determine if more breaths lead to better blood pressure control. It seeks adults with high blood pressure who do not have serious heart or metabolic issues. Participants should not smoke or have certain medical conditions, such as recent surgery or respiratory infections. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance blood pressure management.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must avoid non-prescribed medications for at least 24 hours before each measurement visit.

What prior data suggests that Inspiratory Muscle Strength Training is safe for adults with high blood pressure?

Research has shown that Inspiratory Muscle Strength Training (IMST) is generally safe for people. In past studies, high-resistance IMST safely and effectively improved blood pressure and heart health in middle-aged and older adults. One study discovered that IMST significantly lowered the top number in a blood pressure reading after just six weeks of training. Participants reported no major side effects, making it a promising option for managing blood pressure.

IMST involves using a device to breathe in against resistance, strengthening the breathing muscles. This training is easy to maintain and takes only a few minutes each day. So far, there are no major safety concerns, and previous participants have responded well to the treatment. ^{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 offers a novel, non-drug approach to managing the condition. Traditional treatments often involve medications like ACE inhibitors or beta-blockers, but this technique leverages the power of breathing exercises using the POWERbreathe K5 device. By strengthening the inspiratory muscles, this method could improve blood pressure control without the side effects associated with medication. Plus, the training is quick, taking just a few minutes a day, making it an accessible option for many people.

What evidence suggests that Inspiratory Muscle Strength Training is effective for high blood pressure?

Research has shown that Inspiratory Muscle Strength Training (IMST), which participants in this trial will perform, can help lower blood pressure. One study found that people who did IMST for 6 weeks saw their top blood pressure number drop by about 9 points, with this improvement mostly lasting even 6 weeks after stopping the training. Another study reported a reduction in the top blood pressure number from 135 to 126. However, some research suggests that slow breathing exercises might be more effective for people with high blood pressure than IMST. Despite this, more evidence is emerging to support IMST as a promising way to manage high blood pressure. ^{2 3 4 6 7}

Who Is on the Research Team?

Daniel Craighead, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with above-normal systolic blood pressure who are interested in trying a non-drug method to improve their condition. Specific eligibility details are not provided, but typically participants should be healthy enough to engage in the activities required by the study.

Inclusion Criteria

I am 18 years old or older.

Resting SBP ≥120 mmHg as measured during screening 1 & 2

Free from serious CV or metabolic diseases as identified by self-report and blood chemistry analysis

Exclusion Criteria

I have a ruptured eardrum or another ear condition.

I have had recent abdominal surgery or have an abdominal hernia.

Markedly elevated left ventricular end-diastolic volume and pressure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Inspiratory Muscle Strength Training (IMST) at varying doses for 6 weeks

6 weeks

7 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Strength Training

Trial Overview The study is testing how different doses of Inspiratory Muscle Strength Training (IMST) using a device called POWERbreathe K5 affect blood pressure and vascular function over six weeks.

How Is the Trial Designed?

Group I: 30 Breaths/ Day Active Control 1 Intervention

All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.

Group II: 15 Breaths/ Day Active Control 1 Intervention

All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.

Group III: 45 Breaths/ Day Active Control 1 Intervention

All sessions will be performed at 75% of each participant's PI max 7 days per week, for 6 weeks, using the POWERbreathe K5 device. Each session will take approximately 3-10 minutes depending on the assigned dose group.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

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

Time-Efficient Inspiratory Muscle Training Lowers BP Casual systolic blood pressure decreased from 135±2 mm Hg to 126±3 mm Hg (P<0.01) with IMST, which was ≈75% sustained 6 weeks after IMST (P<0.01) ...

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

Effects of IMT in Hypertension: A Meta-Analysis 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 ...

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. journals.physiology.org journals.physiology.org/doi/full/10.1152/japplphysiol.00425.2022?doi=10.1152/japplphysiol.00425.2022

A multi-trial, retrospective analysis of the antihypertensive ... In young-to-older adult men and women, 6 wk of high-resistance inspiratory muscle strength training lowers casual systolic and diastolic blood pressure by 9 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34184544/

Time-Efficient Inspiratory Muscle Strength Training Lowers ... High-resistance IMST is a safe, highly adherable lifestyle intervention for improving blood pressure and endothelial function in midlife/older adults.

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

Is Inspiratory Muscle Training an Emerging Strategy for ... A study reported that 6 weeks of IMST, performed at 30 breaths per day, 5 days per week, reduced SBP by 10 mm Hg and DBP by 5 mm Hg in young, ...