Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06580964

Heat and Exercise in Aging as Therapy (HEAT)

Led by Texas Tech University · Updated on 2025-09-17

54

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions: 1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes? 2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?

CONDITIONS

Official Title

Heat and Exercise in Aging as Therapy (HEAT)

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 50 years
  • Women who are postmenopausal, defined as no menstrual period for at least 12 consecutive months.
  • Sedentary (structured exercise <30 minutes, 3x/week)
  • Body weight is at least 110 lbs
  • Meet criteria for prediabetes (fasting blood glucose 100-125 mg/dl, hemoglobin A1c 5.7-6.4%)
  • Consume <8 (women) or <15 (men) alcohol-containing beverages per week
  • Do not use nicotine or cannabis
  • Not taking any medications that could interfere with responses to the interventions (e.g., corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, metformin, anticoagulants, barbiturates, insulin sensitizers, fibrates, immunosuppressants). If you don't know, that's okay. We'll ask what medications you are on and check whether they fall into one of these categories.
Not Eligible

You will not qualify if you...

  • History of peripheral neuropathies
  • Currently taking prescription blood thinners
  • Medical complications that could would contraindicate participation in the high intensity interval training (HIIT) intervention including: orthopedic complications that would limit your ability to perform cycling exercise, significant cardiovascular impairments (e.g., history of arrhythmias, severe uncontrolled hypertension, etc.), diagnosed metabolic disease (e.g., diabetes), renal disease, sickle cell anemia, or cancer in remission for <6 months.
  • Known history of slow wound healing
  • Lidocaine allergy
  • Latex allergy
  • Currently pregnant
  • 1.5" subcutaneous fat over the thigh muscle

  • Symptoms suggestive of cardiovascular, respiratory, metabolic, or renal diseases including discomfort, pressure, or pain in your chest, neck, jaw, arms, calves, or other areas potentially related to ischemia; shortness of breath at rest or with mild exertion; dizziness or fainting (syncope); difficulty breathing while lying flat (orthopnea) or sudden nighttime breathing difficulties (paroxysmal nocturnal dyspnea); palpitations or rapid heartbeat (tachycardia); pain or cramping in your legs during physical activity (intermittent claudication); a known heart murmur; swelling in your ankles (edema); unusual fatigue or shortness of breath during routine activities or at rest.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Texas Tech University

Lubbock, Texas, United States, 79409

Actively Recruiting

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Research Team

H

Hui-Ying Luk, PhD

CONTACT

D

Danielle Levitt, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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