NCT03618524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 2, 2018

Last Update Submit

August 12, 2019

Conditions

Endothelial Dysfunction

Keywords

heat stressendothelial functionhot water immersionarterial stiffness

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilation

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

    Up to 2 weeks

Secondary Outcomes (3)

  • Endothelial shear stress

    Up to 2 weeks

  • Pulse wave velocity

    Up to 2 weeks

  • Arterial distensibility

    Up to 2 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Lower limb hot water immersion

Other: Lower limb hot water immersion

Interventions

Lower limb hot water immersionOTHER

Participants will undergo two interventions in separate visits: lower limb hot water (42 deg C) immersion up to the (1) ankles or (2) knees.

Experimental

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • History of cardiovascular, musculoskeletal, or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University Vascular Dynamics Lab

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (9)

  • 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.

    PMID: 27270841BACKGROUND

  • 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.

    PMID: 27418688BACKGROUND

  • 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.

    PMID: 24399113BACKGROUND

  • 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.

    PMID: 17353456BACKGROUND

  • 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.

    PMID: 26892962BACKGROUND

  • 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.

    PMID: 16614368BACKGROUND

  • 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.

    PMID: 21131471BACKGROUND

  • 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.

    PMID: 19546374BACKGROUND

  • 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.

    PMID: 28349094BACKGROUND

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Maureen J MacDonald, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Dean, Faculty of Science

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

January 15, 2019

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)