Evaluating breathing muscle training in cardiac rehabilitation
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
This study is testing if breathing muscle training can improve exercise and heart health for people with heart failure compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04984473 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of inspiratory muscle training combined with cardiac rehabilitation on blood flow and blood pressure responses during exercise in individuals with heart failure. Participants will be divided into two groups: those with heart failure and healthy controls, both of whom will undergo a structured exercise training program. The study will measure various physiological responses to determine the efficacy of the breathing muscle training intervention. The goal is to enhance rehabilitation outcomes for patients with heart failure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a qualifying heart failure indication for cardiac rehabilitation.
Not a fit: Patients who are unable to participate in structured exercise programs or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve exercise tolerance and overall cardiovascular health in patients with heart failure.
How similar studies have performed: While the specific combination of breathing muscle training and cardiac rehabilitation is novel, similar interventions have shown promise in improving outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - Heart Failure Group: * Adult 18 years and older. * English speaking. * Has a qualifying heart failure indication for center-based cardiac rehabilitation. Inclusion Criteria - Healthy Control Group: * Adult 18 years and older. * English speaking. * Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex. Exclusion Criteria: * HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program. * Participants unable/unwilling to provide informed consent. * Uremia, history of allergy to iodides. Impaired renal function. * Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months). * Diagnosis of liver disease.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Smith, PhD — Mayo Clinic
- Study coordinator: Eric Bruhn, MA
- 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.