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NCT04984473 Clinical Trial

A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Healthy Clinical Trial

Official title:
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04984473
Other study ID # 20-009490
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 2024

Study information
Verified date July 2023
Source Mayo Clinic
Contact Eric Bruhn, MA
Phone 507-266-2690
Email bruhn.eric@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 42
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - Heart Failure Group: - Adult 18 years and older. - English speaking. - Has a qualifying heart failure indication for center-based cardiac rehabilitation. Inclusion Criteria - Healthy Control Group: - Adult 18 years and older. - English speaking. - Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure response Mean arterial pressure baseline and 12 week follow up
Primary Change in blood flow response respiratory muscle blood flow baseline and 12 week follow up
Primary Change in limb vascular resistance response Limb vascular resistance baseline and 12 week follow up
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