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NCT Number: NCT06580964

Heat and Exercise in Aging as Therapy (HEAT)

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?

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University

Lubbock, Texas, 79409, United States

Location status: Recruiting

Location contact

Danielle Levitt, Ph.D.

CONTACT

[email protected]

806-834-1830

Danielle Levitt, Ph.D.

PRINCIPAL_INVESTIGATOR

Hui Ying Luk, Ph.D.

CONTACT

[email protected]

806-834-0827

Hui Ying Luk, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

To achieve the study objectives, researchers will first compare the outcomes of local heat therapy to: 1) HIIT and 2) heat pads set to maintain normal skeletal muscle temperature (control group). Then, researchers will compare the outcomes of the local heat therapy and control groups after a subsequent HIIT intervention. This will enable the researchers to assess the effectiveness of local heat therapy (compared to HIIT and preceding HIIT) to improve skeletal muscle health, physical function, blood sugar control.

Study Procedures:

All participants will visit the laboratory over three days at the start of the study for baseline assessments and sample collection.

Participants in the Control (CON) and Local Heat Therapy (LHT) groups will:

Phase 1:

  • Use heat pads on both thighs at a pre-determined temperature for 90 minutes daily, 6 days a week (5 days at home and 1 day in the laboratory; 12 laboratory visits) for the first 12 weeks.
  • Maintain a log of each heat pad session.
  • Visit the laboratory over three days at the end of Phase 1 for follow-up assessments and sample collection.

Phase 2:

  • Visit the laboratory three days per week for 12 weeks (a total of 36 visits) for exercise training.
  • Visit the laboratory over three days at the end of Phase 2 for final assessments and sample collection.

Participants in the HIIT Group will:

Phase 1:

  • Visit the laboratory three days per week for 12 weeks (a total of 36 visits) for exercise training.
  • Visit the laboratory over three days at the end of Phase 1 for final assessments and sample collection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 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.

Exclusion criteria

  • 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.

Treatment and study plan

Heat therapy

Behavioral

Heat pads will be set to a pre-determined, optimized temperature and applied to both legs for 90 min, 6d/wk (5 at-home and 1 in-lab).

High-intensity interval training

Behavioral

High-intensity interval training will be performed 3 days per week for 12 weeks.

Primary outcomes

  1. Glycemic control

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Oral glucose tolerance test (OGTT)

  2. Skeletal muscle architecture 1

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density

  3. Skeletal muscle architecture 2

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Assessment of skeletal muscle mitochondrial content

  4. Frailty status

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Fried's Phenotypic Frailty assessment

  5. Exercise capacity

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    VO2peak testing

Secondary outcomes

  1. Anthropometrics 1

    Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks

    Body mass and height to calculate body mass index (BMI)

  2. Anthropometrics 2

    Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks

    Waist-to-hip ratio

  3. Body composition

    Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Lean versus fat mass assessed by dual-energy x-ray absorptiometry (DEXA)

  4. Sleep quality

    Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks

    7-point likert scale

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Levitt, PhD

CONTACT

[email protected]

8068341830

Hui-Ying Luk, PhD

CONTACT

[email protected]

8068340827

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

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

Acronym: HEAT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 30, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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