Heat and Exercise in Aging as Therapy (HEAT)

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University
Study ID
NCT06580964
Status
Recruiting
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Conditions

  • Prediabetic State

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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?

Key Dates

Start date
Jul 31, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Local Heat Therapy
    Phase 1: Heat pads will be applied to both legs and set to a pre-determined, optimized temperature to raise the intramuscular temperature to 3-4°C above resting. Each heating session will last for 90 min/d, 6d/wk (5 at-home and 1 in-lab) for 12 wks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.
  • Sham Comparator: Thermoneutral Therapy
    Phase 1: Heat pads will be applied to both legs and set to a pre-determined temperature to keep the intramuscular temperature in a thermoneutral state (\~35-37°C). Each heating session will last for 90 min, 7d/wk (6 at-home and 1 in-lab) for 12 weeks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.
  • Active Comparator: High-Intensity Interval Training
    Phase 1: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3. Phase 2: N/A.

Primary Outcome Measure

Glycemic control [ Time Frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech UniversityLubbockTexas79409
Hui Ying Luk, Ph.D.
[email protected]
806-834-0827
Danielle Levitt, Ph.D.
[email protected]
806-834-1830
Hui Ying Luk, Ph.D. (PRINCIPAL_INVESTIGATOR)
Danielle Levitt, Ph.D. (PRINCIPAL_INVESTIGATOR)

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