NCT04588103

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

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

October 2, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

October 2, 2020

Last Update Submit

November 8, 2022

Conditions

Keywords

heat therapyexercise trainingendothelial function

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 INTERVENTION

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

Heat therapy

EXPERIMENTAL

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

Other: Heat therapy

Exercise training

EXPERIMENTAL

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

Other: Exercise training

Combined training

EXPERIMENTAL

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.

Other: Heat therapyOther: Exercise training

Interventions

Lower limb warm water immersion (42 degrees C)

Combined trainingHeat therapy

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

Combined trainingExercise training

Eligibility Criteria

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

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

Location

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: 30676869BACKGROUND
  • 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
  • Heinonen 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: 29351426BACKGROUND
  • Miyata 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: 20154403BACKGROUND
  • Serbulea 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: 22878276BACKGROUND
  • Thijssen 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: 31211361BACKGROUND
  • Van 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: 22278144BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • Gurovich 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.

  • Hesketh 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.

  • Hoekstra 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.

  • Hunter 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.

  • Jakubowski 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.

  • 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.

  • Totosy 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.

  • Cheng 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.

MeSH Terms

Conditions

Hyperthermia

Interventions

DiathermyExercise

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maureen J MacDonald, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

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

Locations