App-Guided Breathing Exercises for High Blood Pressure

Overseen By Elizabeth Jones, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Boulder

Disqualifiers: Unstable cardiovascular disease, recent stroke, cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether breathing exercises guided by a smartphone app can lower high blood pressure, compared to the same exercises assisted by researchers in a clinic. Participants will use a handheld device to perform these exercises for 5 minutes a day, 6 days a week, over 6 weeks. The trial seeks adults with high blood pressure who own a smartphone. Those with stable blood pressure and weight recently, and who are willing to maintain their current medication, may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. If you're on blood pressure medication, your prescription and dosage must be stable for at least 3 months before the study and remain the same during the 6-week trial.

What prior data suggests that these inspiratory muscle strength training methods are safe for lowering blood pressure?

Studies have shown that inspiratory muscle strength training (IMST), whether through an app or in a clinic, is easy for participants to handle. Research indicates that IMST safely and effectively lowers blood pressure. Participants in previous studies found it easy to maintain the routine, which involves only a few minutes of daily breathing exercises.

Few side effects have been reported, and those were mild. For example, some experienced temporary muscle tiredness, but no serious problems occurred. Overall, this training improves heart and blood vessel health, benefiting anyone looking to manage their blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to managing high blood pressure by focusing on inspiratory muscle strength training. Unlike traditional medications like ACE inhibitors or calcium channel blockers, these treatments use a handheld device to guide breathing exercises, either through a smartphone app or under clinical supervision. This method could offer a non-pharmacological option for patients, potentially reducing medication dependence and side effects. The app-based approach is particularly intriguing as it provides flexibility and accessibility for users, allowing them to perform exercises at their convenience while still receiving guidance.

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

Studies have shown that inspiratory muscle strength training (IMST) can help lower blood pressure. This trial will compare two methods: app-based and clinic-based IMST. Research indicates that after just six weeks of IMST, both methods successfully reduced blood pressure in participants. Specifically, one study found a 47% increase in muscle strength, contributing to lower blood pressure. IMST also enhances blood vessel function and reduces damage from harmful molecules called free radicals. Both app-guided and clinic-guided IMST methods offer promising options for managing high blood pressure. ^{1 3 4 5 6}

Who Is on the Research Team?

Daniel H Craighead, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high blood pressure. It's designed to see if a smartphone app can help them strengthen their breathing muscles and lower their blood pressure by guiding them through exercises they do at home.

Inclusion Criteria

Ability to provide informed consent

Willing to accept random assignment to condition

I am on stable blood pressure medication for at least 3 months.

Exclusion Criteria

I am under 18 years old.

Inability to abstain from consumption of alcohol for 12 hours on experimental days.

I haven't donated blood in the last 8 weeks and won't donate for 8 weeks after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform inspiratory muscle strength training (IMST) for 5 minutes a day, 6 days a week, for 6 weeks, guided by either a smartphone app or researchers in a clinical setting

6 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in systolic blood pressure and other health metrics after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• App-Based Inspiratory Muscle Strength Training
• Clinic-Based Inspiratory Muscle Strength Training

Trial Overview

The study compares two ways of doing inspiratory muscle strength training (IMST): one uses a smartphone app to guide the training, while the other is done in a clinic. Participants will do these breathing exercises daily for six weeks.

How Is the Trial Designed?

Group I: App-Based Inspiratory Muscle Strength Training Experimental Treatment 1 Intervention

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.

Group II: Clinic-Based Inspiratory Muscle Strength Training Active Control 1 Intervention

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.

App-Based Inspiratory Muscle Strength Training is already approved in United States for the following indications:

Approved in United States as IMST for:

• Lowering systolic blood pressure in adults with elevated blood pressure

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]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

A study involving 40 critically ill patients showed that using an electronic device for inspiratory muscle training (IMT) was feasible, with 81% of planned sessions completed, indicating good adherence to the intervention.

The electronic IMT was found to be safe, with no major adverse events and only 10% minor adverse events that were transient and without clinical consequences, while over 85% of participants reported it as helpful for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. Nickels, M., Erwin, K., McMurray, G., et al.[2023]

Inspiratory muscle training (IMT) significantly improved inspiratory strength and lung function in young swimmers, with notable increases in the S-Index and maximum inspiratory flow after a four-week program.

Swimmers who underwent IMT showed significantly faster swimming times in 50-m, 100-m, and 200-m events compared to a control group, indicating that enhanced respiratory muscle strength positively impacts swimming performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. Yañez-Sepulveda, R., Alvear-Ordenes, I., Tapia-Guajardo, A., et al.[2021]

Inspiratory muscle training (IMT) significantly improved 5000 m running performance in healthy untrained males when added to a cardiovascular training program, with a notable performance increase of 4.3% compared to 2.2% in the placebo group.

While both groups showed similar improvements in maximal aerobic power (VO2max), the IMT group reported lower perceived effort during training, suggesting that IMT may help athletes feel less fatigued during longer runs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent inspiratory muscle and cardiovascular training differentially improves both perceptions of effort and 5000 m running performance compared with cardiovascular training alone. Edwards, AM., Wells, C., Butterly, R.[2009]

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 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) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

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]

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