The Combined Influence of Pedal Rate and Venous Distension on Exercise Activation of Locomotor Afferents and Cardiovascular Responses

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-009587
    Sponsor Protocol Number: 15-009587

About this study

The first purpose is to investigate the effect of pedal rate during submaximal exercise activation of locomotor muscle afferents on ventilation, gas exchange, blood pressure, and cardiac hemodynamic responses in healthy individuals compared with HF patients. We will determine the influence of pedal rate on ventilation, gas exchange, blood pressure, and cardiac hemodynamic responses on activation of group III and IV locomotor muscle afferents using a novel application and integration of two separate but related scientific questions to better understand peripheral mechanisms of exercise tolerance in humans. The second purpose is to investigate whether pedal rates during exercise with activation of locomotor muscle afferents influences ventilation, gas exchange, blood pressure, and cardiac hemodynamic responses evoked by post-exercise normal recovery (NR), subsystolic regional circulatory occlusion (RCO), or suprasystolic RCO. The third purpose is to compare ventilation, gas exchange, blood pressure, and cardiac hemodynamic responses across the adult healthy aging spectrum and compared with HF patients.

 

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Healthy Adults

  • ≥18 years of age with no history of cardiovascular, pulmonary, metabolic, neurologic, orthopaedic, or other diseases affecting the neuromuscular system.
  • Additional inclusion criteria include:
    • BMI ≤35 kg/m2 
    • Current non-smokers with smoking history <15 pack years 
    • Those who are able to engage in exercise (i.e., without orthopedic limitations or musculoskeletal disorders).

Heart Failure Patients

  • >21 yrs will have no history of dangerous arrhythmia’s 
  • Not be pacemaker dependent 
  • Have a body mass index ≤40 kg/m2 
  • Currently be non-smokers with <15 pack year history  
  • Able to exercise (i.e. without orthopedic limitations or musculoskeletal disorders)
  • Although heart failure medications may influence multiple physiologic systems, we feel it is important, practical, and safe to study these patients under conditions of optimal care. Concurrent withdrawal of ACE-inhibitor, beta-blocker, digoxin, and/or diuretic therapies would likely be associated with moderate decompensation in a high proportion of patients. Accordingly, the impact of our studies will be generalizable to HF patients receiving standard optimized pharmacologic therapy, consistent with the general community. All patients will be managed by their primary care physician or cardiologist with additional review by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.

Exclusion Criteria:

  • Female participants who are pregnant or breast feeding
  • Individuals with a history of cardiovascular, pulmonary, metabolic, neurologic, orthopaedic, or other diseases affecting the neuromuscular system
  • No history of diabetes, hypertension, hypercholesterolemia, smoking, or significant family history (myocardial infarction or sudden death before the age of 55 in father or male first-degree relative or before the age of 65 in mother or female first-degree relative)
  • Additional exclusion criteria include:
    • BMI >35 kg/m2 
    • Current smokers with smoking history ≥15 pack years 
    • Those who are not able to engage in exercise (e.g., known orthopedic limitations or musculoskeletal disorders)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Briana Ziegler

(507)255-7125

Ziegler.Briana@mayo.edu

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CLS-20306536

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