Artery Function Responses to Heat Therapy and Exercise Training
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
1 active site
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
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2022
CompletedNovember 9, 2022
November 1, 2022
11 months
October 2, 2020
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brachial artery endothelial function
Flow-mediated dilation (FMD) is a measure of the ability of the artery to dilate in response to elevated shear stress, and represents endothelial function. For this technique, a pressure cuff will be wrapped around the forearm and then inflated to \~200 mmHg for 5 minutes to occlude blood flow through the artery site. Doppler ultrasound (Vivid q, GE Medical Systems, Horten, Norway) and a 12 MHz linear array probe will be used to measure artery diameter before cuff inflation (rest), before cuff deflation (ischemia), and for three minutes after cuff deflation (reactive hyperemia). Images of the BA will be collected in Duplex mode and obtained proximal to the antecubital fossa. FMD will be calculated using this formula: FMD% = ((peak diameter-baseline diameter)/baseline diameter) Ă— 100%.
Change in endothelial function from week 0 to 8
Arterial stiffness
Pulse wave velocity (PWV) is a measure of the speed at which a pulse travels between two superficial artery sites, and represents arterial stiffness. For this outcome, applanation tonometers (i.e., micromanometer-tipped probes) (SPT-301, Millar Instruments, Houston, Texas, USA) will be used to detect and transmit pulse pressure wave forms at the carotid, femoral, and dorsalis pedis or tibialis posterior arteries. PWV will be calculated between the carotid-femoral arteries and femoral-foot arteries to quantify central and peripheral arterial stiffness, respectively, using this general formula: PWV = distance/pulse transit time.
Change in arterial stiffness from week 0 to 8
Secondary Outcomes (7)
Cardiorespiratory fitness
Change in cardiorespiratory fitness from week 0 to 8
Body composition
Change in body composition from week 0 to 8
Muscle strength
Change in muscle strength from week 0 to 8
Metabolic blood markers
Change in metabolic markers from week 0 to 8
Core temperature
Change in core temperature from week 0 to 8
- +2 more secondary outcomes
Study Arms (4)
Control
NO INTERVENTIONParticipants will be asked to maintain their regular physical activity habits for the duration of the 8-week intervention period.
Heat therapy
EXPERIMENTALParticipants will be asked to undergo 45 minutes of lower limb hot water immersion (42 degrees C) 3 times per week for 8 weeks.
Exercise training
EXPERIMENTALParticipants will be asked to undergo 45 minutes of moderate-intensity cycling exercise (\~40-59% VO2 reserve) 3 times per week for 8 weeks.
Combined training
EXPERIMENTALParticipants 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.
Interventions
Moderate-intensity cycling exercise (\~40-59% VO2 reserve)
Eligibility Criteria
You may qualify if:
- Apparently healthy (i.e., no cardiovascular, musculoskeletal, or metabolic disease)
- years old
- Recreationally and/or physically active
You may not qualify if:
- History of cardiovascular, musculoskeletal, or metabolic disease
- Regular smoking and/or vasoactive drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University Vascular Dynamics Lab
Hamilton, Ontario, L8S 4L8, Canada
Related Publications (20)
Cheng JL, MacDonald MJ. Effect of heat stress on vascular outcomes in humans. J Appl Physiol (1985). 2019 Mar 1;126(3):771-781. doi: 10.1152/japplphysiol.00682.2018. Epub 2019 Jan 24.
PMID: 30676869BACKGROUNDDeanfield 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: 17353456BACKGROUNDGimbrone 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: 26892962BACKGROUNDHeinonen I, Laukkanen JA. Effects of heat and cold on health, with special reference to Finnish sauna bathing. Am J Physiol Regul Integr Comp Physiol. 2018 May 1;314(5):R629-R638. doi: 10.1152/ajpregu.00115.2017. Epub 2017 Dec 20.
PMID: 29351426BACKGROUNDMiyata M, Tei C. Waon therapy for cardiovascular disease: innovative therapy for the 21st century. Circ J. 2010 Apr;74(4):617-21. doi: 10.1253/circj.cj-09-0939. Epub 2010 Feb 13.
PMID: 20154403BACKGROUNDSerbulea M, Payyappallimana U. Onsen (hot springs) in Japan--transforming terrain into healing landscapes. Health Place. 2012 Nov;18(6):1366-73. doi: 10.1016/j.healthplace.2012.06.020. Epub 2012 Jul 17.
PMID: 22878276BACKGROUNDThijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.
PMID: 31211361BACKGROUNDVan Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.
PMID: 22278144BACKGROUNDBailey 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.
PMID: 27286178RESULTBrunt 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: 27418688RESULTBrunt 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: 27270841RESULTCarter 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: 24399113RESULTGurovich AN, Braith RW. Enhanced external counterpulsation creates acute blood flow patterns responsible for improved flow-mediated dilation in humans. Hypertens Res. 2013 Apr;36(4):297-305. doi: 10.1038/hr.2012.169. Epub 2012 Oct 18.
PMID: 23076403RESULTHesketh K, Shepherd SO, Strauss JA, Low DA, Cooper RJ, Wagenmakers AJM, Cocks M. Passive heat therapy in sedentary humans increases skeletal muscle capillarization and eNOS content but not mitochondrial density or GLUT4 content. Am J Physiol Heart Circ Physiol. 2019 Jul 1;317(1):H114-H123. doi: 10.1152/ajpheart.00816.2018. Epub 2019 May 10.
PMID: 31074654RESULTHoekstra SP, Bishop NC, Faulkner SH, Bailey SJ, Leicht CA. Acute and chronic effects of hot water immersion on inflammation and metabolism in sedentary, overweight adults. J Appl Physiol (1985). 2018 Dec 1;125(6):2008-2018. doi: 10.1152/japplphysiol.00407.2018. Epub 2018 Oct 18.
PMID: 30335579RESULTHunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Elmenshawy A, Tanaka H. The effect of Bikram yoga on endothelial function in young and middle-aged and older adults. J Bodyw Mov Ther. 2017 Jan;21(1):30-34. doi: 10.1016/j.jbmt.2016.06.004. Epub 2016 Jun 17.
PMID: 28167186RESULTJakubowski JS, Wong EPT, Nunes EA, Noguchi KS, Vandeweerd JK, Murphy KT, Morton RW, McGlory C, Phillips SM. Equivalent Hypertrophy and Strength Gains in beta-Hydroxy-beta-Methylbutyrate- or Leucine-supplemented Men. Med Sci Sports Exerc. 2019 Jan;51(1):65-74. doi: 10.1249/MSS.0000000000001752.
PMID: 30113522RESULTSchlader 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.
PMID: 25786484RESULTTotosy de Zepetnek JO, Ditor DS, Au JS, MacDonald MJ. Impact of shear rate pattern on upper and lower limb conduit artery endothelial function in both spinal cord-injured and able-bodied men. Exp Physiol. 2015 Oct;100(10):1107-17. doi: 10.1113/EP085056. Epub 2015 Aug 18.
PMID: 26206681RESULTCheng JL, Pizzola CA, Mattook KC, Noguchi KS, Armstrong CM, Bagri GK, Macdonald MJ. Effects of Lower Limb Heat Therapy, Exercise Training, or a Combined Intervention on Vascular Function: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Jan 1;57(1):94-105. doi: 10.1249/MSS.0000000000003550. Epub 2024 Sep 16.
PMID: 39283227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen J MacDonald, PhD
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 19, 2020
Study Start
July 13, 2021
Primary Completion
June 18, 2022
Study Completion
June 18, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share