Recruiting

Breathing Muscle Training

Sponsor:

Mayo Clinic

Code:

NCT04984473

Conditions

Healthy

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Inspiratory muscle training

Study Details

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.

Conditions

Healthy

Heart Failure

Study ID

NCT04984473

Start date

Jun 1, 2021

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

sham comparator: Sham arm

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

active comparator: Non-sham arm

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

Interventions

Inspiratory muscle training

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

Primary outcome measure

  • Blood pressure response [ Time Frame: baseline and 12 week follow up ]
  • Change in blood flow response [ Time Frame: baseline and 12 week follow up ]
  • Change in limb vascular resistance response [ Time Frame: baseline and 12 week follow up ]

Central Contacts and Locations

Central contacts

Eric Bruhn, MA

507-266-2690bruhn.eric@mayo.edu

Joshua Smith

smith.joshua1@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-17.