Heat and Exercise in Aging as Therapy (HEAT)
ConditionPrediabetic State
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorTexas Tech University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Heat therapy
BehavioralHeat 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
BehavioralHigh-intensity interval training will be performed 3 days per week for 12 weeks.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Local Heat TherapyExperimental treatment 2 interventions
Group B: Thermoneutral TherapySham comparator 2 interventions
Group C: High-Intensity Interval TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic control
Oral glucose tolerance test (OGTT)
Time frame
Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)2
Skeletal muscle architecture 1
Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density
Time frame
Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)3
Skeletal muscle architecture 2
Assessment of skeletal muscle mitochondrial content
Time frame
Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)4
Frailty status
Fried's Phenotypic Frailty assessment
Time frame
Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)Secondary outcomes
1
Anthropometrics 1
Body mass and height to calculate body mass index (BMI)
Time frame
Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks2
Anthropometrics 2
Waist-to-hip ratio
Time frame
Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks3
Body composition
Lean versus fat mass assessed by dual-energy x-ray absorptiometry (DEXA)
Time frame
Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)4
Sleep quality
7-point likert scale
Time frame
Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeksSponsors and contacts
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Source ClinicalTrials.gov