Clinical trial NCT04588103: Artery Function Responses to Heat Therapy and Exercise Training
Official title: The Effects of 8 Weeks of Lower Limb Heat Therapy, Moderate-intensity Cycling Exercise, or Both on Vascular Function in Young, Healthy Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: heat therapy
exercise training
endothelial function
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore the effects of 8 weeks of local leg heat therapy, exercise training, or both on measures of vascular function, cardiorespiratory fitness, and muscle strength in young, healthy individuals. Participants will be allocated into either a control group that will maintain their regular physical activity habits; or into one of three training groups: heat therapy will involve lower limb warm water immersion, exercise training will involve moderate-intensity cycling, and combined training will involve both performed in sequential order.

Detailed description: A between-groups interventional design will be used in a cohort of 80 young, healthy males and females 18-35 years old. Interested individuals will be invited to the lab for a screening and familiarization visit (1 hr), in which participants will be introduced to various lab testing protocols to ensure proper performance and tolerance during experimental data collection sessions. Participants will be randomized into one of four groups for an 8-week intervention period: (1) no training (CON), (2) lower limb heat therapy (HEAT), (3) moderate intensity cycling training (EX), or (4) combined training (HEATEX). CON will involve maintenance of regular physical activity habits. HEAT will involve 45 minutes of lower limb hot water immersion (42 °C) using a custom-made heating apparatus 3x/week. EX will involve of 45 minutes of cycling on an ergometer at 40-59% VO2reserve 3x/week. HEATEX will require participants to perform 3x/week of exercise training and heat therapy consecutively and in that order, such that each session is 90 minutes in duration. In total, all groups except CON will be expected to complete 24 intervention sessions. Vascular function will be characterized by measures of endothelial function, arterial stiffness, arterial structure, central hemodynamics, arterial blood flow and shear, and endothelial cell nitric oxide production. Muscle and metabolic adaptations will be characterized by measures of cardiorespiratory fitness, body composition, muscle strength and thickness, and fasting glucose and insulin. Inflammatory profile will be characterized by concentrations of interleukins, heat shock proteins, and cortisol. Thermal physiological adaptations will be characterized by measures of core and skin temperature and sweat rate. Perceptual responses will be characterized by measures of thermal comfort and sensation, calmness, alertness, mood, affect, and ratings of perceived exertion. Intervention adherence will be tracked throughout the intervention period. For the acute investigation (3-hr visit), outcome measures will be assessed before and immediately following the first and last training session. For the chronic investigation (2-hr visit), outcome measures will be assessed at weeks 0, 2, 4, 6, and 8 of the intervention period.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy (i.e., no cardiovascular, musculoskeletal, or metabolic disease)
* 18-35 years old
* Recreationally and/or physically active

Exclusion Criteria:

* History of cardiovascular, musculoskeletal, or metabolic disease
* Regular smoking and/or vasoactive drug use

Primary outcomes:
measure: Brachial artery endothelial function
timeFrame: Change in endothelial function from week 0 to 8
measure: Arterial stiffness
timeFrame: Change in arterial stiffness from week 0 to 8
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change in cardiorespiratory fitness from week 0 to 8
measure: Body composition
timeFrame: Change in body composition from week 0 to 8
measure: Muscle strength
timeFrame: Change in muscle strength from week 0 to 8
measure: Metabolic blood markers
timeFrame: Change in metabolic markers from week 0 to 8
measure: Core temperature
timeFrame: Change in core temperature from week 0 to 8
measure: Endothelial cell nitric oxide production markers
timeFrame: Change in endothelial nitric oxide production from week 0 to 8
measure: Heat shock protein mRNA and content
timeFrame: Change in heat shock proteins from week 0 to 8
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Vascular Dynamics Lab
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen J MacDonald, PhD
role: PRINCIPAL_INVESTIGATOR
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