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A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04984473
Enrollment
42
Registered
2021-07-30
Start date
2021-06-01
Completion date
2027-08-01
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Heart Failure

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.

Interventions

DEVICEInspiratory muscle training

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure responsebaseline and 12 week follow upMean arterial pressure
Change in blood flow responsebaseline and 12 week follow uprespiratory muscle blood flow
Change in limb vascular resistance responsebaseline and 12 week follow upLimb vascular resistance

Countries

United States

Contacts

CONTACTEric Bruhn, MA
bruhn.eric@mayo.edu507-266-2690
CONTACTJoshua Smith
smith.joshua1@mayo.edu
PRINCIPAL_INVESTIGATORJoshua Smith, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026