A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Mayo Clinic

Status: Enrolling

Conditions: Healthy; Heart Failure

Treatments: Device: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT04984473

20-009490

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Sham arm

Sham Comparator group

Description:

Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

Treatment:

Device: Inspiratory muscle training

Non-sham arm

Active Comparator group

Description:

Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.

Treatment:

Device: Inspiratory muscle training