Inspiratory muscle training combined with cardiac rehabilitation for heart failure with reduced ejection fraction
Impact Of Adding Inspiratory Muscle Training To Cardiac Rehabilitation On Exercise Responses In Heart Failure
This trial will try inspiratory muscle training added to cardiac rehabilitation to see if it improves heart function and exercise responses in adults with heart failure and reduced ejection fraction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07086131 on ClinicalTrials.gov |
What this trial studies
This interventional study tests whether adding inspiratory muscle training (IMT) using a Powerbreathe device to standard cardiac rehabilitation (CR) changes cardiovascular and exercise responses in people with heart failure with reduced ejection fraction (HFrEF). Participants are adults on guideline-directed medical therapy with NYHA class I–III symptoms who can perform exercise and have no recent hospitalizations. The protocol delivers supervised CR plus a course of IMT and compares exercise and cardiovascular function outcomes to CR without IMT. The single-center study is conducted at Mayo Clinic in Rochester and involves clinical screening and in-person supervised sessions.
Who should consider this trial
Good fit: Ideal candidates are adults with HFrEF (NYHA I–III) who have been on guideline-directed medical therapy for at least six weeks, can perform exercise, are non-smokers with BMI ≤45, and have no recent hospitalizations.
Not a fit: Patients with recent sustained ventricular arrhythmias, high-degree heart block, severe kidney dysfunction (GFR <30), current heavy smokers or long smoking history, very high BMI (>45), pregnancy, or those unable to exercise are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could improve respiratory muscle strength, exercise capacity, and overall cardiovascular function, helping patients feel less short of breath and more active.
How similar studies have performed: Previous smaller trials of inspiratory muscle training in heart failure have shown improved respiratory muscle strength and exercise tolerance, but combining IMT with formal cardiac rehabilitation is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for \>6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the \>3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with \<30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise). Exclusion Criteria 1. sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1; 2. second or third degree heart block; 3. body mass index \>45 kg/m2; 4. current smokers and/or smoking history \>30 pack years; 5. pregnant women (testing will be done by research team if requested); 6. glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1); 7. individuals who are not able to engage in exercise; 8. symptomatic peripheral artery disease; 9. asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea; 10. ruptured eardrum or any other condition of the ear; 11. history of spontaneous pneumothorax or osteoporosis with a history of rib fractures; 12. history of lung disease. For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Smith, Ph.D. — Mayo Clinic
- Study coordinator: Eric Bruhn, M.A
- Email: bruhn.eric@mayo.edu
- Phone: 507-266-2690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.