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

Launched by UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Heat Therapy, Functional Capacity, and Vascular Health in Older Adults," is designed to explore how heat therapy applied to the legs at home can help improve walking ability, blood vessel health, and exercise performance in older adults. The researchers want to see if this simple therapy can make a positive difference in the lives of people aged 55 to 80 who might have difficulty with mobility.

To participate, individuals must be between 55 and 80 years old, not use tobacco products in the last six months, and have normal blood pressure and heart health. Participants will be closely monitored by healthcare professionals throughout the study. It's important to note that certain medical conditions or medications may exclude individuals from joining the trial. If you meet the eligibility criteria, this may be a great opportunity to contribute to research that could benefit older adults everywhere!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 55 to 80 years of age
• • 2. No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches, and vapor smoking)
• • 3. Systolic blood pressure \<140 mmHg; diastolic blood pressure \<90 mmHg
• • 4. Normal 12-lead ECG (reviewed by a physician)
• • 5. Normal clinical results from a medical exam reviewed by a board-certified physician (e.g., General Health Questionnaire - see attached document)
• • 6. Body mass index (BMI) \<40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• • 7. Females Only: Post-menopausal
• Exclusion Criteria:
• • 1. Not meeting the age criteria
• • 2. Body mass index (BMI) \>40 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• • 3. Use of tobacco or nicotine products within the last 6 months (tobacco cigarettes, chewing tobacco, nicotine patches or gum)
• • 4. 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)
• • 5. S who weigh less than 80 lbs
• • 6. Use of prescription drugs, non-prescription drugs or herbal medicines known to alter vascular function unless cleared prior to the study
• • 7. Use of anti-hypertensive medications
• • 8. Use of beta blockers
• • 9. Daily use of bronchodilators
• • 10. Current use of anti-coagulant therapy
• • 11. Current use of hormone replacement therapy (e.g., estrogen, testosterone)
• • 12. Current diagnosis of cancer
• • 13. 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)
• • 14. History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy, increased intracranial pressure)
• • 15. Known history of atherosclerosis (i.e., plaque formation)
• • 16. Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, idiopathic orthostatic hypotension)
• • 17. 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
• • 18. History of anaphylaxis
• • 19. Severe phobia of needles
• • 20. History of alcohol or drug abuse which inhibits the participants ability to complete this study
• • 21. Latex allergy
• • 22. Known allergies or sensitivities to drugs used in the study (e.g., Lidocaine HCL, acetylcholine HCL, methacholine chloride, sodium nitroprusside, nitroglycerin, or related drugs)
• • 23. Implanted electronic medical devices (e.g. cardiac pacemaker)
• • 24. Tissue or skin abnormalities of the legs (e.g., infection, injury, open wound, ischemic tissue, phlebitis, active bleeding, neuropathy)
• • 25. Tissue or skin abnormalities of the arm (e.g., unhealed or open wound or circulatory deficits)
• • 26. 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