Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588103
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2020-10-02
Brief Title:
Artery Function Responses to Heat Therapy and Exercise Training
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3xweek EX will involve of 45 minutes of cycling on an ergometer at 40-59 VO2reserve 3xweek HEATEX will require participants to perform 3xweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None