Heat and Exercise in Aging as Therapy (HEAT)
- Conditions
- Prediabetic State
- Interventions
- Behavioral: Heat therapyBehavioral: High-intensity interval training
- Registration Number
- NCT06580964
- Lead Sponsor
- Texas Tech University
- Brief Summary
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?
- Detailed Description
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, 7 days a week (6 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Sedentary (structured exercise <30 minutes, 3x/week)
- Meet criteria for prediabetes (fasting blood glucose 100-125 mg/dl and/or hemoglobin A1c 5.7-6.4%)
- Age ≥ 60 years
- Body weight ≥ 110 pounds
- 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 [PPAR gamma agonist])
- 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 the ability of the participant to perform cycling exercise, significant cardiovascular impairments (e.g., history of arrhythmias, severe uncontrolled hypertension, etc.), diagnosed metabolic disease (e.g., diabetes), renal disease, and cancer in remission for <6 months.
- Excessive subcutaneous fat over the muscle (greater than 1.5")
- Currently pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local Heat Therapy 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 \~40°C. Each heating session will last for 90 min/d, 7d/wk (6 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 at 90-95% HRpeak for 4 min with 3 min active rest. Local Heat Therapy High-intensity interval training Phase 1: Heat pads will be applied to both legs and set to a pre-determined, optimized temperature to raise the intramuscular temperature to \~40°C. Each heating session will last for 90 min/d, 7d/wk (6 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 at 90-95% HRpeak for 4 min with 3 min active rest. Thermoneutral Therapy Heat 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 at 90-95% HRpeak for 4 min with 3 min active rest. High-Intensity Interval Training 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 at 90-95% HRpeak for 4 min with 3 min active rest. Phase 2: N/A Thermoneutral Therapy High-intensity interval training 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 at 90-95% HRpeak for 4 min with 3 min active rest.
- Primary Outcome Measures
Name Time Method Glycemic control 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)
Skeletal muscle architecture 1 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
Skeletal muscle architecture 2 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
Frailty status 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
Exercise capacity Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group) VO2peak testing
- Secondary Outcome Measures
Name Time Method Anthropometrics 1 Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks Body mass and height to calculate body mass index (BMI)
Anthropometrics 2 Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks Waist-to-hip ratio
Body composition 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)
Sleep quality Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks 7-point likert scale
Trial Locations
- Locations (1)
Texas Tech University
🇺🇸Lubbock, Texas, United States