RecruitingPhase 1Phase 2NCT05706181

Heat Therapy, Functional Capacity, and Vascular Health in Older Adults

Home-based Heat Therapy to Improve Functional Capacity and Vascular Health in Older Adults


Sponsor

University of North Texas Health Science Center

Enrollment

72 participants

Start Date

Nov 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.


Eligibility

Min Age: 55 YearsMax Age: 80 Years

Inclusion Criteria7

  • 55 to 80 years of age
  • No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches, and vapor smoking)
  • Systolic blood pressure <140 mmHg; diastolic blood pressure <90 mmHg
  • Normal 12-lead ECG (reviewed by a physician)
  • Normal clinical results from a medical exam reviewed by a board-certified physician (e.g., General Health Questionnaire - see attached document)
  • Body mass index (BMI) <40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
  • Females Only: Post-menopausal

Exclusion Criteria26

  • Not meeting the age criteria
  • Body mass index (BMI) >40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
  • Use of tobacco or nicotine products within the last 6 months (tobacco cigarettes, chewing tobacco, nicotine patches or gum)
  • Not abstaining from the following 24 hours prior to the experimental session: exercise, alcoholic substances, prescription or non-prescription medications (unless cleared by the medical screener), dietary supplements, herbal medications, caffeinated substances (including chocolate, coffee, tea (iced or hot), caffeinated energy drinks, and sodas)
  • S who weigh less than 80 lbs
  • Use of prescription drugs, non-prescription drugs or herbal medicines known to alter vascular function unless cleared prior to the study
  • Use of anti-hypertensive medications
  • Use of beta blockers
  • Daily use of bronchodilators
  • Current use of anti-coagulant therapy
  • Current use of hormone replacement therapy (e.g., estrogen, testosterone)
  • Current diagnosis of cancer
  • Signs of overt cardio-metabolic abnormalities (e.g., uncontrolled diabetes - HbA1c >7.5, a resting systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg; abnormal 12-lead ECG)
  • History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy, increased intracranial pressure)
  • Known history of atherosclerosis (i.e., plaque formation)
  • Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, idiopathic orthostatic hypotension)
  • Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease). Note: subjects with exercised-induced asthma or who have had COVID-19 will be allowed to participate
  • History of anaphylaxis
  • Severe phobia of needles
  • History of alcohol or drug abuse which inhibits the participants ability to complete this study
  • Latex allergy
  • Known allergies or sensitivities to drugs used in the study (e.g., Lidocaine HCL, acetylcholine HCL, methacholine chloride, sodium nitroprusside, nitroglycerin, or related drugs)
  • Implanted electronic medical devices (e.g. cardiac pacemaker)
  • Tissue or skin abnormalities of the legs (e.g., infection, injury, open wound, ischemic tissue, phlebitis, active bleeding, neuropathy)
  • Tissue or skin abnormalities of the arm (e.g., unhealed or open wound or circulatory deficits)
  • Current Fever (oral temp >99.5 °F/ 37.5 °C) aa) Current use of PDE3 inhibitors (e.g., Viagra) or soluble guanylate cyclase (sGC) stimulators (e.g., riociguat), or unwillingness to withhold medication for 2 weeks prior to laboratory testing bb) Diagnosis of neurological disease or cognitive dysfunction cc) Cardiac surgery or cardiac events (e.g., coronary artery bypass graft surgery, myocardial infarction, heart failure) dd) Abnormal clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs ee) Individuals who have had mastectomies ff) History of methemoglobinemia

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Interventions

OTHERHome-based leg heat therapy

Participants will be required to perform 8 weeks of leg heat therapy using water-perfused pants 4 times per week, with each session lasting 60 min. Skin temperature will be heated to about 40 °C. The pants heating system (consisting of pants and a water circulator/heater) can finely and uniformly control these designated skin temperatures. Participants will be randomly assigned to a group and provided with the pant heating system as well as a log book in which they are required to track the dates of each session. Participants will also measure their blood pressure and heart rate prior to, during, and immediately after each heating session using a portable oscillometric device provided by our laboratory.

OTHERHome-based sham therapy

Participants will be required to perform 8 weeks of leg heat therapy using water-perfused pants 4 times per week, with each session lasting 60 min. Skin temperature will be heated to about 40 °C. The pants heating system (consisting of pants and a water circulator/heater) can finely and uniformly control these designated skin temperatures. Participants will be randomly assigned to a group and provided with the pant heating system as well as a log book in which they are required to track the dates of each session. Participants will also measure their blood pressure and heart rate prior to, during, and immediately after each heating session using a portable oscillometric device provided by our laboratory.


Locations(1)

University of North Texas Health Science Center

Fort Worth, Texas, United States

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NCT05706181


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