Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies: a Single-center Pilot Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • POWERbreathe KH2

    Device

    IMT is a noninvasive, exercise-based intervention designed to improve inspiratory muscle strength and endurance by providing a resistive load during inhalation.

  • Usual Care

    Other intervention

    Usual 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

30 Participants
are divided into 2 treatment groups
Group A: Inspiratory Muscle Training (IMT) + Usual CareExperimental treatment 2 interventions
Group B: Usual Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of completed training session

Time frame
Final Visit (up to 6 months)
2

Time required to administer and monitor IMT sessions

Time frame
Final Visit (up to 6 months)
3

Number of left ventricular assist device (LVAD) implantation or heart transplantation

Time frame
Final Visit (up to 6 months)

Secondary outcomes

1

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.

Time frame
Baseline, Post-operative
2

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)).

Time frame
Baseline, Final Visit (up to 6 months)
3

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)).

Time frame
Baseline, Final Visit (up to 6 months)
4

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

Time frame
Baseline, Final Visit (up to 6 months)

Other outcomes

Sponsors and contacts

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