A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

July 14, 2025 updated by: Joshua R. Smith, Mayo Clinic

Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Joshua R. Smith, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham arm
Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
Device: Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
Active Comparator: Non-sham arm
Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.
Device: Inspiratory muscle training
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure response
Time Frame: baseline and 12 week follow up
Mean arterial pressure
baseline and 12 week follow up
Change in blood flow response
Time Frame: baseline and 12 week follow up
respiratory muscle blood flow
baseline and 12 week follow up
Change in limb vascular resistance response
Time Frame: baseline and 12 week follow up
Limb vascular resistance
baseline and 12 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Joshua Smith, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-009490

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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