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NCT07862738Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
2 Oct 2026
Start date
10 Nov 2026
Primary completion date
10 May 2027
Lead sponsor
NYU Langone Health
NCT number
NCT07862738

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 10 Nov 2026 to the primary completion date, 10 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with an expectedpreoperative inpatient hospital stay of less than 10 days, based onreview of clinical status, treatment plan, and timing of expected surgery
  • Abdominal surgery during present admission

Other illness

  • Patients discharged from the hospital to await advanced therapies (LVAD or heart transplant)
  • Untreated hypertension, defined as systolic blood pressure consistently \>140 mmHg or diastolic blood pressure consistently \>90 mmHg in the absence of antihypertensive therapy.
  • Patients with planned multiple organ transplant (e.g. heart and kidney, heart and lung)
  • A burst eardrum that has not fully healed, or any other condition of the eardrum
  • Patients with worsening heart failure signs and symptoms after IMT

Other

  • Patients with acute pneumothorax
  • Presence of acute rib fracture(s)
  • Patients with acute cerebrovascular accident
  • Acute delirium
  • Perforated tympanic membrane
  • Hemodynamic instability
  • Patients currently requiring mechanical ventilatory support
  • Patients with asthma who suffer from frequent severe exacerbations
  • Patients with marked elevated left ventricular end-diastolic volume and pressure
  • If you have suffered from or are likely to suffer from costochondritis

Who the study is looking for

  • 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
  • Able to follow instructions including the use of the Borg Dyspnea scale
  • Physically able to independently hold and use the IMT
  • 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.
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.