A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Not Applicable

Recruiting

• Conditions: Heart Failure; Healthy
• Interventions: Device: Inspiratory muscle training

• Registration Number: NCT04984473
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

• HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
• Participants unable/unwilling to provide informed consent.
• Uremia, history of allergy to iodides. Impaired renal function.
• Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
• Diagnosis of liver disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-sham arm	Inspiratory muscle training	Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Sham arm	Inspiratory muscle training	Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Blood pressure response	baseline and 12 week follow up	Mean arterial pressure
Change in blood flow response	baseline and 12 week follow up	respiratory muscle blood flow
Change in limb vascular resistance response	baseline and 12 week follow up	Limb vascular resistance

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States