RECRUITING

Heat and Exercise in Aging as Therapy (HEAT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy

Quick Facts

Study Start:2025-07-01
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06580964

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 60 years
  2. * Sedentary (structured exercise \<30 minutes, 3x/week)
  3. * Body weight is at least 110 lbs
  4. * Meet criteria for prediabetes (fasting blood glucose 100-125 mg/dl, hemoglobin A1c 5.7-6.4%)
  5. * Consume \<8 (women) or \<15 (men) alcohol-containing beverages per week
  6. * Do not use nicotine or cannabis
  7. * 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.
  1. * History of peripheral neuropathies
  2. * Currently taking prescription blood thinners
  3. * 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.
  4. * Known history of slow wound healing
  5. * Lidocaine allergy
  6. * Latex allergy
  7. * Currently pregnant
  8. * \>1.5" subcutaneous fat over the thigh muscle
  9. * 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.

Contacts and Locations

Study Contact

Hui-Ying Luk, PhD
CONTACT
8068340827
huiying.luk@ttu.edu
Danielle Levitt, PhD
CONTACT
8068341830
danielle.levitt@ttu.edu

Principal Investigator

Hui-Ying Luk, PhD; Danielle Levitt, PhD
PRINCIPAL_INVESTIGATOR
Texas Tech University

Study Locations (Sites)

Texas Tech University
Lubbock, Texas, 79409
United States

Collaborators and Investigators

Sponsor: Texas Tech University

  • Hui-Ying Luk, PhD; Danielle Levitt, PhD, PRINCIPAL_INVESTIGATOR, Texas Tech University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2029-07

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Exercise
  • Heat
  • Aging
  • Prediabetes
  • Skeletal Muscle

Additional Relevant MeSH Terms

  • Prediabetic State