A Study Investigating the Impact of IMT With CR On Exercise Responses In HF

NCT07086131 | Recruiting FDA Device

• 2 other identifiers: 25-0058711R01HL176491-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• Change in locomotor muscle blood flow during exercise

  Locomotor muscle blood flows will be measured via Doppler-ultrasound. This will be measured in mL/min.

  Baseline, 12 weeks

• Change in respiratory muscle cost of breathing (VO2)

  Respiratory muscle cost of breathing is the oxygen uptake (VO2) to the respiratory muscles. Respiratory muscle VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute.

  Baseline, 12 weeks

Study Arms (2)

Inspiratory muscle training (IMT)

EXPERIMENTAL

IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.

Device: Powerbreathe

SHAM

SHAM COMPARATOR

IMT performed at 5% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.

Device: Powerbreathe

Interventions

Powerbreathe DEVICE

The breathing training will consist of using the PowerBreathe for 12 weeks. The PowerBreathe is an inspiratory pressure threshold trainer. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.

Inspiratory muscle training (IMT); SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1;
• second or third degree heart block;
• body mass index \>45 kg/m2;
• current smokers and/or smoking history \>30 pack years;
• pregnant women (testing will be done by research team if requested);
• glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1);
• individuals who are not able to engage in exercise;
• symptomatic peripheral artery disease;
• asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea;
• ruptured eardrum or any other condition of the ear;
• history of spontaneous pneumothorax or osteoporosis with a history of rib fractures;
• history of lung disease.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Joshua Smith, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Bruhn, M.A

CONTACT

507-266-2690; bruhn.eric@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)