Inspiratory Muscle Training for Heart Failure

CN
AS
Overseen ByAngela Stolfi, PT, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

AS

Angela Stolfi, PT, DPT

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people hospitalized with heart failure who are being evaluated for advanced heart treatments. Participants must be able to take part in physical therapy and use a breathing training device.

Inclusion Criteria

I can hold and use the IMT device by myself.
I have a current or planned physical therapy order from my medical team.
I am 18 years old or older.
See 5 more

Exclusion Criteria

I currently have a broken rib.
I have a hole or tear in my eardrum.
Patients currently requiring mechanical ventilatory support
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inspiratory muscle training (IMT) and usual care physical therapy, or usual care physical therapy only

6 months
Weekly sessions with physical therapist

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in 6MWT, dyspnea, and MIP

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares usual hospital care with or without inspiratory muscle training using the POWERbreathe KH2 device, aiming to see if adding this breathing exercise is safe, practical, and helps improve patients' strength and recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Inspiratory Muscle Training (IMT) + Usual CareExperimental Treatment2 Interventions
Group II: Usual Care OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+