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Effect of Local Heat Stress Via Leg Bath on Artery Function (HEAT)

Primary Purpose

Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lower limb hot water immersion
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endothelial Dysfunction focused on measuring heat stress, endothelial function, hot water immersion, arterial stiffness

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Apparently health (i.e., no cardiovascular, musculoskeletal, or metabolic disease), 18-35 years old 18-35 years old Recreationally active (exercising 2-3 times per week)

Exclusion Criteria:

History of cardiovascular, musculoskeletal, or metabolic disease

Sites / Locations

  • McMaster University Vascular Dynamics Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Lower limb hot water immersion

Outcomes

Primary Outcome Measures

Flow-mediated dilation
Collected using vascular ultrasound and analyzed using semi-automated edge tracking software

Secondary Outcome Measures

Endothelial shear stress
Calculated using blood velocity and arterial diameter obtained from vascular ultrasound, and blood density and viscosity calculated using hematocrit
Pulse wave velocity
Collected using applanation tonometry and analyzed using data acquisition software
Arterial distensibility
Collected using ultrasound imaging and applanation tonometry, and analyzed using semi-automated edge tracking software and data acqusition software

Full Information

First Posted
August 2, 2018
Last Updated
August 12, 2019
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03618524
Brief Title
Effect of Local Heat Stress Via Leg Bath on Artery Function
Acronym
HEAT
Official Title
Effect of Local Heat Stress Via Leg Bath on Artery Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Arteries are flexible in their structure and function and change in response to a variety of factors. Endothelial cells, are the skin type cells that form a layer inside arteries, and they are very important for arterial health. When they work properly, they produce substances that make the artery enlarge and support a healthy environment; but when they do not work properly, they produce substances that make the artery constrict and lead to a harmful environment. We can measure the function of these cells using an ultrasound machine and a quick test. The application of heat has been shown to change the structure and function of arteries, but we need to understand how these changes happen before we can effectively use heat as a therapy. Limb heating protocols (e.g., leg bath), in contrast with whole-body heating modes (e.g., sauna), are appealing as therapies because they generally cost less and are easier to use; but evidence is needed to demonstrate that they work before widespread use can be considered. Imagine soaking your legs in a bathtub filled with warm water becoming part of the options you have for staying healthy. Clearly, there is a lot of potential for heat to be used as a therapy, particularly for people who are unable to, or have difficulty participating in other health interventions that are known to improve arterial, but we need to do this type of research before we are able to recommend warm foot baths for therapeutic purposes.
Detailed Description
A within-subjects interventional design will be used in a cohort of 16 young, healthy males and females between the ages of 18-35 years old. Interested individuals will be invited to the lab for a screening and familiarization visit, in which the brachial artery (BA) and superficial femoral artery (SFA) will be scanned to vet for ultrasound image quality and BA and SFA flow-mediated dilation tests will be performed to ensure participant tolerance during collection visits. According to current FMD guidelines, all qualified participants will be instructed to refrain from vigorous physical activity > 24 hours, alcohol and caffeine > 8 hours, and food > 6 hours prior to each of the two experimental visits. Participants will also be asked to ingest a wireless telemetry pill 2 hours prior to each of the two experimental visits. Upon arrival, basic anthropometric measures will be collected and hematocrit will be measured in duplicate with a finger prick blood sample equivalent to two 70 µl capillary tubes. Experimental visits will begin with 10 minutes of supine rest, while the participant is instrumented with skin temperature probes on the foot, calf, thigh, chest, and arm for measurement of skin temperature; single-lead ECG (Powerlab model ML795, ADInstruments, Colorado Springs, CO, USA) and non-invasive finger cuff (Finometer MIDI, Finapres, The Netherlands) for continuous heart rate and blood pressure monitoring. Following rest, BA and SFA FMD tests will be conducted to assess baseline endothelial function. Afterwards, single-point laser Doppler flowmetry focused on the forearm will be used to track skin blood flow continuously throughout heating. The heating protocol will involve participants immersing their lower limbs either up to the ankles or the knees in a 42 °C water bath for 45 minutes, in separate conditions. The order by which participants undergo these interventions will be randomized. Five minutes after the conclusion of the intervention, BA and SFA FMD tests will be conducted to assess endothelial function in the acute phase. BA and SFA blood velocities, blood flow turbulence, endothelial shear rate, and oscillatory shear index will be assessed before and during each of the interventions; and arterial stiffness defined as carotid-femoral pulse wave velocity (PWV) and common carotid artery (CCA) distensibility will be assessed before and after each of the interventions as additional outcomes. Participants will provide written informed consent prior to beginning any portion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction
Keywords
heat stress, endothelial function, hot water immersion, arterial stiffness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Lower limb hot water immersion
Intervention Type
Other
Intervention Name(s)
Lower limb hot water immersion
Intervention Description
Participants will undergo two interventions in separate visits: lower limb hot water (42 deg C) immersion up to the (1) ankles or (2) knees.
Primary Outcome Measure Information:
Title
Flow-mediated dilation
Description
Collected using vascular ultrasound and analyzed using semi-automated edge tracking software
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Endothelial shear stress
Description
Calculated using blood velocity and arterial diameter obtained from vascular ultrasound, and blood density and viscosity calculated using hematocrit
Time Frame
Up to 2 weeks
Title
Pulse wave velocity
Description
Collected using applanation tonometry and analyzed using data acquisition software
Time Frame
Up to 2 weeks
Title
Arterial distensibility
Description
Collected using ultrasound imaging and applanation tonometry, and analyzed using semi-automated edge tracking software and data acqusition software
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Apparently health (i.e., no cardiovascular, musculoskeletal, or metabolic disease), 18-35 years old 18-35 years old Recreationally active (exercising 2-3 times per week) Exclusion Criteria: History of cardiovascular, musculoskeletal, or metabolic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen J MacDonald, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Vascular Dynamics Lab
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27270841
Citation
Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.
Results Reference
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PubMed Identifier
27418688
Citation
Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplphysiol.00424.2016. Epub 2016 Jul 14.
Results Reference
background
PubMed Identifier
24399113
Citation
Carter HH, Spence AL, Atkinson CL, Pugh CJ, Naylor LH, Green DJ. Repeated core temperature elevation induces conduit artery adaptation in humans. Eur J Appl Physiol. 2014 Apr;114(4):859-65. doi: 10.1007/s00421-013-2817-2. Epub 2014 Jan 8.
Results Reference
background
PubMed Identifier
17353456
Citation
Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.
Results Reference
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PubMed Identifier
26892962
Citation
Gimbrone MA Jr, Garcia-Cardena G. Endothelial Cell Dysfunction and the Pathobiology of Atherosclerosis. Circ Res. 2016 Feb 19;118(4):620-36. doi: 10.1161/CIRCRESAHA.115.306301.
Results Reference
background
PubMed Identifier
16614368
Citation
Kellogg DL Jr. In vivo mechanisms of cutaneous vasodilation and vasoconstriction in humans during thermoregulatory challenges. J Appl Physiol (1985). 2006 May;100(5):1709-18. doi: 10.1152/japplphysiol.01071.2005.
Results Reference
background
PubMed Identifier
21131471
Citation
Naylor LH, Carter H, FitzSimons MG, Cable NT, Thijssen DH, Green DJ. Repeated increases in blood flow, independent of exercise, enhance conduit artery vasodilator function in humans. Am J Physiol Heart Circ Physiol. 2011 Feb;300(2):H664-9. doi: 10.1152/ajpheart.00985.2010. Epub 2010 Dec 3.
Results Reference
background
PubMed Identifier
19546374
Citation
Tinken TM, Thijssen DH, Hopkins N, Black MA, Dawson EA, Minson CT, Newcomer SC, Laughlin MH, Cable NT, Green DJ. Impact of shear rate modulation on vascular function in humans. Hypertension. 2009 Aug;54(2):278-85. doi: 10.1161/HYPERTENSIONAHA.109.134361. Epub 2009 Jun 22.
Results Reference
background
PubMed Identifier
28349094
Citation
Wong BJ, Hollowed CG. Current concepts of active vasodilation in human skin. Temperature (Austin). 2016 Jun 21;4(1):41-59. doi: 10.1080/23328940.2016.1200203. eCollection 2017.
Results Reference
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Effect of Local Heat Stress Via Leg Bath on Artery Function

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