70 Participants Needed

Powerbreathe for Heart Failure

EB
Overseen ByEric Bruhn, M.A
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Guideline directed therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how the breathing exercise device, Powerbreathe, combined with cardiac rehab, can improve heart function in people with heart failure. Researchers will compare two groups: one using the device at a low setting and the other at a higher setting. Ideal candidates for this trial are those living with heart failure, who have not been hospitalized recently, and can exercise without major issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for heart failure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on guideline-directed medical therapy for heart failure for more than 6 weeks, so you may need to continue your current heart failure medications.

What prior data suggests that this device is safe for heart failure patients?

Studies have shown that inspiratory muscle training (IMT) is generally safe for people with heart failure. This training strengthens the muscles used for breathing. Research indicates that it can improve the coordination of heart and lung function without causing major problems.

For example, one study found that IMT can safely enhance heart failure patients' ability to perform daily activities. Another review of studies showed that IMT did not cause serious side effects. These findings suggest that Powerbreathe, a device used for IMT, is well-tolerated. While individual experiences can vary, current evidence supports the safety of this treatment for improving heart and lung function in those with heart failure.12345

Why are researchers excited about this trial?

Most treatments for heart failure, like medications or devices, aim to manage symptoms or improve heart function. But Powerbreathe is different because it focuses on strengthening the respiratory muscles using a technique called inspiratory muscle training (IMT). Unlike traditional methods, this approach could enhance breathing efficiency and potentially boost overall heart health. Researchers are excited because if successful, it offers a non-invasive, drug-free option to support heart failure patients in a unique way.

What evidence suggests that Powerbreathe is effective for heart failure?

This trial will compare two approaches to inspiratory muscle training (IMT) for heart failure. Research has shown that IMT strengthens breathing muscles and improves quality of life for people with heart failure. It also reduces certain heart stress markers. In this trial, one group will perform IMT at 40% maximal inspiratory pressure (MIP), while another group will perform a sham IMT at 5% MIP. IMT is especially recommended for those with long-term heart failure and other heart conditions. Overall, IMT improves breathing and heart health in these patients.678910

Who Is on the Research Team?

JS

Joshua Smith, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for heart failure patients with a BMI ≤45 kg/m2, who can exercise and have been on heart medications for over 6 weeks. They should be non-smokers or have quit long ago, without recent hospitalizations, and not severely limited by other health issues.

Inclusion Criteria

Body mass index ≤45 kg/m2
Ability to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)
I am over 18 and have been on heart failure medication for more than 6 weeks.
See 3 more

Exclusion Criteria

Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1
Body mass index >45 kg/m2
Pregnant women
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) for 12 weeks

12 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for changes in cardiovascular function and exercise responses

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Powerbreathe
Trial Overview The study tests if using Powerbreathe (a device for inspiratory muscle training) along with standard cardiac rehabilitation improves cardiovascular function in heart failure patients compared to usual care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inspiratory muscle training (IMT)Experimental Treatment1 Intervention
Group II: SHAMPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Inspiratory Muscle Training in Patients With Heart Failure ...A randomized controlled trial of inspiratory muscle training in stable chronic heart failure. ... Exercise anaerobic threshold and ventilatory efficiency identify ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39391548/
Efficacy of Inspiratory Muscle Training in Patients With ...Background: Inspiratory muscle training (IMT) is supported for outpatients with stable chronic heart failure, but its efficacy in hospitalized ...
The efficacy of inspiratory muscle training in improving ...Conclusion. IMT significantly improved respiratory muscle strength, QoL, and reduced cardiac biomarker levels in patients with both heart failure with preserved ...
Effectiveness of Inspiratory Muscle Training in Individuals ...IMT is recommended to individuals with cardiac disease, particularly those with coronary artery disease and chronic heart failure [11–17].
The efficacy of inspiratory muscle training in improving ...Conclusion. IMT significantly improved respiratory muscle strength, QoL, and reduced cardiac biomarker levels in patients with both heart failure with preserved ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/23512093/
High-intensity vs. Sham Inspiratory Muscle Training ...Main outcomes were strength and endurance of the respiratory muscles ... Heart failure; Inspiratory muscle training; Muscle endurance; Muscle strength.
Inspiratory Muscle Training in Hospitalized Heart Failure ...... safe intervention capable of improving the functional capacity of patients with heart failure. Despite the known benefits, to date there are ...
Safety and efficacy of inspiratory muscle training for ...heart disease; acute respiratory failure (characterised by ... Inspiratory muscle training in patients with heart failure: meta-analysis of randomized trials.
Time‐Efficient Inspiratory Muscle Strength Training Lowers ...Healthy lifestyle practices can decrease cardiovascular disease risk, but adherence is low. •. This study demonstrates that high‐resistance ...
A comparison of the effects of inspiratory muscle strength ...Studies have widely investigated the effects of inspiratory muscle strength training in patients with heart failure (HF). The effects of inspiratory muscle ...
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