About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old or older
Able to provide consent and willing to participate in study procedures
Currently hospitalized awaiting advanced therapies (LVAD or heart transplant)
Diagnosed with NYHA class III or IV heart failure
Disqualifiers
Patients discharged from the hospital to await advanced therapies (LVAD or heart transplant)
Patients with an expectedpreoperative inpatient hospital stay of less than 10 days, based onreview of clinical status, treatment plan, and timing of expected surgery
Patients with acute pneumothorax
Presence of acute rib fracture(s)
Trial design
Parallel
Treatments tested in this trial
POWERbreathe KH2
DeviceIMT is a noninvasive, exercise-based intervention designed to improve inspiratory muscle strength and endurance by providing a resistive load during inhalation.
Usual Care
Other interventionUsual care physical therapy may include functional mobility training, therapeutic activities, gait training, and therapeutic exercise, delivered according to the treating physical therapist's clinical judgment and the patient's medical status.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of completed training session
Time required to administer and monitor IMT sessions
Number of left ventricular assist device (LVAD) implantation or heart transplantation
Secondary outcomes
Change in Six-Minute Walk Test (6MWT) in meters
The 6MWT measures the total distance in meters that a person can walk on a flat, hard surface over a period of 6 minutes to evaluate functional exercise capacity. The primary score is the total distance walked in meters. Healthy adults typically walk between 400 and 700 meters.
Change in Borg Category-Ratio (CR) 10 Dyspnea Scale at rest
The Borg CR10 Dyspnea Scale is a numerical rating tool that patients use to report how difficult their breathing feels at a specific moment. The scale ranges from 0 (Nothing at all) to 10 (Maximal (the worst breathing difficulty the person has ever experienced)).
Change in Borg CR10 Dyspnea Scale following exertion
The Borg CR10 Dyspnea Scale is a numerical rating tool that patients use to report how difficult their breathing feels at a specific moment. The scale ranges from 0 (Nothing at all) to 10 (Maximal (the worst breathing difficulty the person has ever experienced)).
Change in maximal inspiratory pressure (MIP)
MIP measures the strength of your breathing muscles, like the diaphragm and ribs. MIP values are recorded in centimeters of water (cmH₂O) as negative numbers. Note: Because it measures negative pressure, a larger negative number means stronger muscles
Sponsors and contacts
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