Heart FailureNCT07862738
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
A study testing POWERbreathe KH2 in people with Heart Failure and Heart Failure New York Heart Association Class III, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association Class IV
- What is being tested?
- POWERbreathe KH2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2026to 10 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
- Patients with acute cerebrovascular accident
- Untreated hypertension, defined as systolic blood pressure consistently >140 mmHg or diastolic blood pressure consistently >90 mmHg in the absence of antihypertensive therapy.
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- Acute delirium
- Perforated tympanic membrane
- Hemodynamic instability
- Abdominal surgery during present admission
- Patients with planned multiple organ transplant (e.g. heart and kidney, heart and lung)
- Patients currently requiring mechanical ventilatory support
- A burst eardrum that has not fully healed, or any other condition of the eardrum
- Patients with asthma who suffer from frequent severe exacerbations
- Patients with marked elevated left ventricular end-diastolic volume and pressure
- Patients with worsening heart failure signs and symptoms after IMT
- If you have suffered from or are likely to suffer from costochondritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
This randomized prospective, pilot study will enroll 30 adults hospitalized with heart failure and awaiting advanced therapies (LVAD or Heart Transplant). One group will receive usual care PT while the intervention group will be instructed in the use of an inspiratory muscle trainer to be performed at least 5 days a week with the supervision of a physical therapist. Both groups will undergo testing of Maximal Inspiratory Pressure (MIP) using the POWERbreathe® Inspiratory Muscle Trainer. Data collection will include Maximal Inspiratory Pressure (MIP), 6-minute walk test (6MWT) distance, dyspnea at rest and with exertion, at the start, every two weeks from start, and end of study period.
- Conditions
- Heart Failure, Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association Class IV
- Being tested
- POWERbreathe KH2, Usual Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERbreathe KH2Device
IMT is a noninvasive, exercise-based intervention designed to improve inspiratory muscle strength and endurance by providing a resistive load during inhalation.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) + Usual Care | Experimental | Participants will perform IMT 1 set of 30 breaths at 50% MIP, 5 days/week, in addition to usual care physical therapy. Receives: Device: POWERbreathe KH2; Other: Usual Care |
| Usual Care Only | Active comparator | Participants in this arm will receive usual care physical therapy only. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of completed training session
Measured: Final Visit (up to 6 months)
Time required to administer and monitor IMT sessions
Measured: Final Visit (up to 6 months)
Number of left ventricular assist device (LVAD) implantation or heart transplantation
Measured: Final Visit (up to 6 months)
Secondary outcomes (6)
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.
Measured: Baseline, Post-operative
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)).
Measured: Baseline, Final Visit (up to 6 months)
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)).
Measured: Baseline, Final Visit (up to 6 months)
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
Measured: Baseline, Final Visit (up to 6 months)
Post-operative ICU length of stay (LOS)
Measured: From post-operative admission until discharge (up to 4 weeks)
Post-operative hospital LOS
Measured: From post-operative admission until discharge (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Stolfi, PT, DPT, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862738
- Sponsor's protocol ID
- 25-01584
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Angela.stolfi@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07862738
- Acronym / sponsor ID
- 25-01584
- Conditions
- Heart Failure, Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association Class IV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized prospective, pilot study will enroll 30 adults hospitalized with heart failure and awaiting advanced therapies (LVAD or Heart Transplant). One group will receive usual care PT while the intervention group will be instructed in the use of an inspiratory muscle trainer to be performed at least 5 days a week with the supervision of a physical therapist. Both groups will undergo testing of Maximal Inspiratory Pressure (MIP) using the POWERbreathe® Inspiratory Muscle Trainer. Data collection will include Maximal Inspiratory Pressure (MIP), 6-minute walk test (6MWT) distance, dyspnea at rest and with exertion, at the start, every two weeks from start, and end of study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) + Usual Care | Experimental | Device: POWERbreathe KH2, Other: Usual CareParticipants will perform IMT 1 set of 30 breaths at 50% MIP, 5 days/week, in addition to usual care physical therapy. |
| Usual Care Only | Active comparator | Other: Usual CareParticipants in this arm will receive usual care physical therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
- Patients with acute cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POWERbreathe KH2IMT is a noninvasive, exercise-based intervention designed to improve inspiratory muscle strength and endurance by providing a resistive load during inhalation. | Device | Inspiratory Muscle Training (IMT) + Usual Care |
| Usual CareUsual 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. | Other | Inspiratory Muscle Training (IMT) + Usual Care, Usual Care Only |
Primary outcome
Percentage of completed training session
Time frame: Final Visit (up to 6 months)
Time required to administer and monitor IMT sessions
Time frame: Final Visit (up to 6 months)
Number of left ventricular assist device (LVAD) implantation or heart transplantation
Time frame: Final Visit (up to 6 months)
6 secondary outcomes
Change in Six-Minute Walk Test (6MWT) in meters
Time frame: Baseline, Post-operative
Change in Borg Category-Ratio (CR) 10 Dyspnea Scale at rest
Time frame: Baseline, Final Visit (up to 6 months)
Change in Borg CR10 Dyspnea Scale following exertion
Time frame: Baseline, Final Visit (up to 6 months)
Change in maximal inspiratory pressure (MIP)
Time frame: Baseline, Final Visit (up to 6 months)
Post-operative ICU length of stay (LOS)
Time frame: From post-operative admission until discharge (up to 4 weeks)
Post-operative hospital LOS
Time frame: From post-operative admission until discharge (up to 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Angela.stolfi@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Stolfi, PT, DPT principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERbreathe KH2 in people with Heart Failure and Heart Failure New York Heart Association Class III, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Stolfi, PT, DPT (212-263-6074, Angela.stolfi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of completed training session (time frame: Final Visit (up to 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.