A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Overview

About this study

We are currently enrolling both healthy volunteers and people who have been diagnosed with heart failure to participate in our research study.  The purpose of this study is to better understand the relationship between exercise, breathing, blood flow and blood pressure.  This study includes two study visits if you are a healthy or heart failure volunteer.    All testing will be performed at our testing center at St. Mary’s Hospital located in Rochester, MN. 

On the first study visit, the research activities will be discussed and all questions will be answered. Once written consent is provided and the participant is enrolled, lung function and exercise capacity will be measured.

The second study visit includes two separate breathing muscle workouts (a light and moderate workload) each followed by 10 min of light to moderate cycling exercise. In addition, two breathing tests will also be performed. During this visit, blood is drawn during exercise.

If you are a patient at Mayo Clinic, who is currently enrolled or will be enrolling in a cardiac rehabilitation exercise program, you will have the option to complete four study visits.  Your first two study visits as described above will be completed at the beginning of cardiac rehabilitation and then we will ask you to return to complete those same two study visits following the completion of your cardiac rehabilitation program.

Remuneration and parking reimbursement are provided.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Heart Failure Group:

  • Patients ≥ 18 years.
  • No history of dangerous arrhythmias.
  • Not pacemaker dependent.
  • Having a body mass index ≤ 40kg/m^2.
  • Currently non-smokers with < 15 pack year history.
  • Able to exercise (i.e., without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise). 

Inclusion Criteria - Healthy Control Group:

  • Adults ≥ 18 years of age.
  • Absent a history of HFpEF or HFrEF, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system.
  • Controls will be matched for age and sex.

Additional inclusion criteria include:

  • BMI ≤ 40kg/m^2.
  • current non-smokers with smoking history < 15 pack years.
  • Able to engage in exercise (i.e., without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).

Exclusion Criteria:

  • History of dangerous arrhythmias.
  • Body mass index > 40 kg/m^2.
  • Current smokers and/or smoking history > 15 pack years.
  • Pregnant women (testing will be done by research team if requested).
  • Uremia, history of allergy to iodides.
  • Impaired renal function.
  • Peripheral artery disease.
  • Creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months).
  • Diagnosis of liver disease.
  • Individuals who are not able to engage in exercise.
  • Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea.
  • Ruptured eardrum or any other condition of the ear.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Olson, Ph.D., M.S.

Open for enrollment

Contact information:

Joshua Smith Ph.D.

(507) 266-2690

bruhn.eric@mayo.edu

More information

Publications

Publications are currently not available