Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Comparing the Addition of Inspiratory Muscle Training (IMT) to Usual Care Physical Therapy in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies: a Single-center Pilot Feasibility Study
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 whether training the muscles used to breathe in is safe and practical during hospital physical therapy. It is for adults with severe heart failure who are waiting for a heart pump or heart transplant. The study also checks whether training improves walking, breathing, and breathing muscle strength before surgery and shortens hospital and intensive care stays after surgery.
The primary objective of this study is to evaluate the feasibility and safety of inspiratory muscle training (IMT) when implemented as part of routine inpatient physical therapy care in patients undergoing evaluation for advanced heart therapies. The secondary aim is to determine if IMT improves 6-minute walk test (6MWT), dyspnea, Maximal Inspiratory Pressure (MIP) pre-operatively. Thirdly, to determine if IMT decreases ICU and hospital length of stay post-operatively.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- You can give consent and agree to study tasks.
- You are in the hospital waiting for a left ventricular assist device (LVAD), a pump that helps the heart, or a heart transplant.
- You have NYHA class III or IV heart failure, meaning symptoms greatly limit activity or happen at rest.
- You can follow instructions and use a scale to rate how short of breath you feel.
- You can hold and use the breathing training device on your own.
- You have a physical therapy order before joining. If needed, the study team will ask your medical team for one.
- You meet the hospital's safety rules for physical therapy before joining and before each session. Your medical team must clear you, including checks of blood pressure, pulse, breathing, oxygen levels, and overall stability.
Who can't join
- You have left the hospital to wait for a heart pump or transplant, or you are expected to stay fewer than 10 days before surgery.
- You have a recent collapsed lung, broken rib, stroke, or sudden confusion.
- Your blood pressure stays above 140 for the top number or 90 for the bottom number without treatment, or your blood flow and blood pressure are unstable.
- You have a torn eardrum that has not healed or another eardrum problem.
- You had belly surgery during this hospital stay, or you plan to receive more than one organ in a transplant.
- You need a machine to support your breathing, or you have asthma with frequent, severe flare-ups.
- Your heart's main pumping chamber holds far too much blood and has very high pressure when filling, or your heart failure symptoms get worse after breathing training.
- You have had, or are likely to get, costochondritis—painful swelling where the ribs meet the breastbone.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 18 years old or older 2. Able to provide consent and willing to participate in study procedures 3. Currently hospitalized awaiting advanced therapies (LVAD or heart transplant) 4. Diagnosed with NYHA class III or IV heart failure 5. Able to follow instructions including the use of the Borg Dyspnea scale 6. Physically able to independently hold and use the IMT 7. Patients will undergo screening with or without active PT orders. To be enrolled in the study, patient must have an active physical therapy order. . If no active order exists, one will be requested from medical team following the screening and prior to enrollment. 8. Participants must meet institutional criteria for participation in physical therapy and mobility activities prior to enrollment and before each IMT session. Medical stability may include: * Mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg * Resting heart rate between 40 and 140 beats per minute * No evidence of active myocardial ischemia or unstable angina * No uncontrolled atrial or ventricular arrhythmias * No escalating vasopressor or inotropic support at time of intervention * Oxygen saturation ≥ 94% on current oxygen support * Respiratory rate between 8 and 35 breaths per minute * Ability to follow simple commands and participate in study procedures * No acute neurologic, respiratory, or hemodynamic deterioration requiring immediate escalation of care * Clearance by the treating medical team to participate in rehabilitation activities Exclusion Criteria: 1. Patients discharged from the hospital to await advanced therapies (LVAD or heart transplant) 2. Patients with an expectedpreoperative inpatient hospital stay of less than 10 days, based onreview of clinical status, treatment plan, and timing of expected surgery 3. Patients with acute pneumothorax 4. Presence of acute rib fracture(s) 5. Patients with acute cerebrovascular accident 6. Untreated hypertension, defined as systolic blood pressure consistently \>140 mmHg or diastolic blood pressure consistently \>90 mmHg in the absence of antihypertensive therapy. 7. Acute delirium 8. Perforated tympanic membrane 9. Hemodynamic instability 10. Abdominal surgery during present admission 11. Patients with planned multiple organ transplant (e.g. heart and kidney, heart and lung) 12. Patients currently requiring mechanical ventilatory support 13. A burst eardrum that has not fully healed, or any other condition of the eardrum 14. Patients with asthma who suffer from frequent severe exacerbations 15. Patients with marked elevated left ventricular end-diastolic volume and pressure 16. Patients with worsening heart failure signs and symptoms after IMT 17. If you have suffered from or are likely to suffer from costochondritis
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York