Actively Recruiting
Impact Of Adding Inspiratory Muscle Training To Cardiac Rehabilitation On Exercise Responses In Heart Failure
Led by Mayo Clinic · Updated on 2025-09-25
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding inspiratory muscle training (IMT) to cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure with reduced ejection fraction (HFrEF). The study aims to compare exercise responses in these patients, who have specific heart failure symptoms and are receiving guideline-directed medical therapy. This interventional trial is sponsored by Mayo Clinic and uses a randomized, double-blind design. Participants will be assigned to one of two groups: one group performs IMT at 40% maximal inspiratory pressure (MIP) and the other performs a sham IMT at 5% MIP. Both groups use the PowerBreathe device, an inspiratory pressure threshold trainer, for 30 minutes, three times a week, over 12 weeks. The device blocks airflow until a threshold pressure is reached by forceful inhalation, training the inspiratory muscles. During the trial, participants will be monitored at baseline and after 12 weeks to assess changes in locomotor muscle blood flow during exercise and in the respiratory muscle's oxygen cost of breathing (VO2). The study involves exercise testing and assessments related to cardiovascular and respiratory function. The total trial participation lasts 12 weeks, with careful monitoring to evaluate the impact of the training on exercise responses in heart failure patients.
CONDITIONS
Brief Title
A Study Investigating the Impact of IMT With CR On Exercise Responses In HF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with heart failure with reduced ejection fraction (HFrEF)
- Receiving guideline-directed medical therapy for more than 6 weeks or have contraindications to medical therapy
- New York Heart Association (NYHA) symptoms class I to III
- No hospitalizations in the past 3 months
- Body mass index (BMI) of 45 kg/m2 or less
- Non-smokers with less than 30 pack-year smoking history
- Able to exercise without significant orthopedic or musculoskeletal limitations
You will not qualify if you...
- Sustained ventricular tachycardia or ventricular fibrillation within 21 days before visit 1
- Second or third degree heart block
- Body mass index (BMI) over 45 kg/m2
- Current smokers or smoking history over 30 pack years
- Pregnant women (pregnancy testing done if requested)
- Glomerular filtration rate below 30 mL/min/1.73m2
- Unable to engage in exercise
- Symptomatic peripheral artery disease
- Asthma with severe exacerbations or low symptom perception
- Ruptured eardrum or other ear conditions
- History of spontaneous pneumothorax or osteoporosis with rib fractures
- History of lung disease
- Additional exclusions for those agreeing to DEXA scanning, including recent gastrointestinal contrast or radionuclide use, severe degenerative changes or fractures in measurement areas, or inability to remain still during scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants use the PowerBreathe device for inspiratory muscle training (IMT) at either 40% or 5% maximal inspiratory pressure for 30 minutes, 3 days a week for 12 weeks.
Regular device use at home with periodic monitoring visits
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
E
Eric Bruhn, M.A
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here