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

ConditionHeart Failure With Reduced Ejection Fraction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Inspiratory muscle training (IMT)Experimental treatment 1 intervention

Group B: SHAMSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Baseline, 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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