A Study Investigating the Impact of IMT With CR On Exercise Responses In HF
Impact Of Adding Inspiratory Muscle Training To Cardiac Rehabilitation On Exercise Responses In Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how breathing muscle training combined with heart rehab affects how the heart and blood vessels work. It is for adults with heart failure whose heart pumps less blood than normal.
The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older with heart failure and reduced heart pumping strength.
- Taking recommended heart failure medicines for more than 6 weeks, unless those medicines are not safe for you.
- Heart failure symptom class I–III, meaning no symptoms to marked limits during activity.
- No hospital stays in more than 3 months.
- Body mass index (BMI), a measure of weight compared with height, of 45 or less.
- Not smoking now, with less than 30 pack-years of past smoking. One pack-year means smoking one pack a day for one year.
- Able to exercise, without major bone, joint, or muscle problems that limit exercise.
Who can't join
- Certain dangerous heart rhythms within 21 days before visit 1, or second- or third-degree heart block, a problem with the heart’s electrical signals.
- BMI above 45, smoking now, or a smoking history above 30 pack-years.
- Pregnancy or a kidney filtering rate below 30, which means very poor kidney function.
- Unable to exercise, or symptoms from poor blood flow in arteries outside the heart.
- A history of lung disease, or asthma with poor awareness of symptoms and frequent, severe flare-ups or unusually low awareness of shortness of breath.
- A torn eardrum or any other ear condition.
- A past collapsed lung that happened on its own, or weak bones called osteoporosis with past broken ribs.
- For those choosing the optional DEXA body scan: recent digestive tract contrast dye or radioactive tracers; severe wear-and-tear changes or changes from broken bones in areas being scanned; or trouble getting into position or staying still.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
MN
- Mayo Clinic in Rochester · Rochester, MN 55905Joshua R Smith · Principal investigatorMore trials in Rochester