Artery Function Responses to Heat Therapy and Exercise Training

NCT ID: NCT04588103

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-06-18

Brief Summary

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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

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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.

Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Participants will be asked to maintain their regular physical activity habits for the duration of the 8-week intervention period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Heat therapy

Participants will be asked to undergo 45 minutes of lower limb hot water immersion (42 degrees C) 3 times per week for 8 weeks.

Group Type EXPERIMENTAL

Heat therapy

Intervention Type OTHER

Lower limb warm water immersion (42 degrees C)

Exercise training

Participants will be asked to undergo 45 minutes of moderate-intensity cycling exercise (\~40-59% VO2 reserve) 3 times per week for 8 weeks.

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

Moderate-intensity cycling exercise (\~40-59% VO2 reserve)

Combined training

Participants will be asked to undergo 90 minutes of moderate-intensity cycling exercise and lower limb hot water immersion sequentially 3 times per week for 8 weeks.

Group Type EXPERIMENTAL

Heat therapy

Intervention Type OTHER

Lower limb warm water immersion (42 degrees C)

Exercise training

Intervention Type OTHER

Moderate-intensity cycling exercise (\~40-59% VO2 reserve)

Interventions

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Heat therapy

Lower limb warm water immersion (42 degrees C)

Intervention Type OTHER

Exercise training

Moderate-intensity cycling exercise (\~40-59% VO2 reserve)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maureen J MacDonald, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University Vascular Dynamics Lab

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Reference Type RESULT
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Reference Type BACKGROUND
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Bailey TG, Cable NT, Miller GD, Sprung VS, Low DA, Jones H. Repeated Warm Water Immersion Induces Similar Cerebrovascular Adaptations to 8 Weeks of Moderate-Intensity Exercise Training in Females. Int J Sports Med. 2016 Sep;37(10):757-65. doi: 10.1055/s-0042-106899. Epub 2016 Jun 10.

Reference Type RESULT
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Reference Type RESULT
PMID: 27418688 (View on PubMed)

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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Schlader ZJ, Gagnon D, Adams A, Rivas E, Cullum CM, Crandall CG. Cognitive and perceptual responses during passive heat stress in younger and older adults. Am J Physiol Regul Integr Comp Physiol. 2015 May 15;308(10):R847-54. doi: 10.1152/ajpregu.00010.2015. Epub 2015 Mar 18.

Reference Type RESULT
PMID: 25786484 (View on PubMed)

Other Identifiers

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HEATEX

Identifier Type: -

Identifier Source: org_study_id

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