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

NCT ID: NCT07086131

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2029-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory muscle training (IMT)

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

Group Type: EXPERIMENTAL

Powerbreathe

Intervention Type: 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.

SHAM

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

Group Type: SHAM_COMPARATOR

Powerbreathe

Intervention Type: 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.

Interventions

Powerbreathe

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.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

1. sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1;

2. second or third degree heart block;

3. body mass index >45 kg/m2;

4. current smokers and/or smoking history >30 pack years;

5. pregnant women (testing will be done by research team if requested);

6. 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);

7. individuals who are not able to engage in exercise;

8. symptomatic peripheral artery disease;

9. asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea;

10. ruptured eardrum or any other condition of the ear;

11. history of spontaneous pneumothorax or osteoporosis with a history of rib fractures;

12. history of lung disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Joshua R. Smith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eric Bruhn, M.A

Role: CONTACT

bruhn.eric@mayo.edu

507-266-2690

Other Identifiers

1R01HL176491-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-005871

Identifier Type: -

Identifier Source: org_study_id