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

Trial Summary

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 data supports the effectiveness of the treatment App-Based Inspiratory Muscle Strength Training for high blood pressure?

Research shows that inspiratory muscle training (IMT) can improve respiratory muscle strength and has been used to help manage conditions like hypertension (high blood pressure). A meta-analysis suggests that IMT may be beneficial as an additional approach for people with high blood pressure. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been used safely in various settings, including for patients with chronic respiratory conditions and those undergoing rehabilitation. While the studies focus on different conditions, they do not report significant safety concerns, suggesting that IMT is generally safe for human use. ^{1 2 4 6 7}

How is the App-Based Inspiratory Muscle Strength Training treatment different from other treatments for high blood pressure?

This treatment is unique because it uses an app to guide breathing exercises that strengthen the muscles used for inhaling, which can help lower blood pressure by improving respiratory muscle strength. Unlike traditional medications, this approach focuses on physical therapy to enhance cardiovascular health. ^{2 3 4 8 9}

What is the purpose of this trial?

This clinical trial aims to assess the efficacy of inspiratory muscle strength training (IMST) guided by a smartphone app vs. IMST delivered in a clinical research setting for lowering systolic blood pressure in adults 18 years and older with elevated blood pressure. Participants will perform IMST for 5 minutes a day, 6 days a week, for 6 weeks.

Research Team

Daniel H Craighead, PhD

Principal Investigator

University of Colorado, Boulder

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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) 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

2. Australia 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Singapore pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]

8. England 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. [2009]

9. 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]