NCT05800808

Brief Summary

The goal of this observational study was to better understand the impact of increased plasma volume on later exercise in hypoxia. Investigators examined young, healthy, males who regularly participated in aerobic exercise. Investigators first measured participant's response to exercise in hypoxia (simulated \~7,500 feet above sea level). The investigators then had participants either 1) undergo 1 bout of high intensity interval exercise or 2) undergo 1 bout of moderate, continuous exercise. 48 hours after the exercise, participants were again examined in hypoxia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

Study Start

First participant enrolled

January 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

February 28, 2023

Last Update Submit

April 4, 2023

Conditions

Keywords

Hypervolemiahigh intensity exercisealtitude exposure

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin Concentration

    measured through spectroscopy

    through study completion, an average of 4 weeks

  • Hematocrit Concentration

    measured through hematocrit reader

    through study completion, an average of 4 weeks

Secondary Outcomes (2)

  • Time Trial Time

    through study completion, an average of 4 weeks

  • Cardiac Output

    through study completion, an average of 4 weeks

Study Arms (2)

High Intensity Exercise

EXPERIMENTAL

Vigorous cycling

Procedure: High Intensity Intervals

Continuous Moderate Exercise

ACTIVE COMPARATOR

Leisurely cycling

Procedure: Moderate Exercise

Interventions

8x4 min cycling bouts at 85% of VO2peak

High Intensity Exercise

81 minutes of cycling at 50% VO2peak

Continuous Moderate Exercise

Eligibility Criteria

Age18 Years - 38 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males age 18-38
  • Exercise at least 3 times/week for at least 30 minutes/day for the past 3 months.

You may not qualify if:

  • Frequent hot bath or sauna users
  • Resided at altitude greater than 2,500 meters for \>14 days.
  • Cardiovascular or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Baptist University

Riverside, California, 92504-3206, United States

Location

Related Publications (16)

  • Alexander JK, Hartley LH, Modelski M, Grover RF. Reduction of stroke volume during exercise in man following ascent to 3,100 m altitude. J Appl Physiol. 1967 Dec;23(6):849-58. doi: 10.1152/jappl.1967.23.6.849. No abstract available.

    PMID: 6065055BACKGROUND
  • Beidleman BA, Staab JE, Muza SR, Sawka MN. Quantitative model of hematologic and plasma volume responses after ascent and acclimation to moderate to high altitudes. Am J Physiol Regul Integr Comp Physiol. 2017 Feb 1;312(2):R265-R272. doi: 10.1152/ajpregu.00225.2016. Epub 2016 Dec 30.

    PMID: 28039191BACKGROUND
  • Berger NJ, Campbell IT, Wilkerson DP, Jones AM. Influence of acute plasma volume expansion on VO2 kinetics, VO2 peak, and performance during high-intensity cycle exercise. J Appl Physiol (1985). 2006 Sep;101(3):707-14. doi: 10.1152/japplphysiol.00154.2006. Epub 2006 May 11.

    PMID: 16690793BACKGROUND
  • Brothers MD, Wilber RL, Byrnes WC. Physical fitness and hematological changes during acclimatization to moderate altitude: a retrospective study. High Alt Med Biol. 2007 Fall;8(3):213-24. doi: 10.1089/ham.2007.8308.

    PMID: 17824822BACKGROUND
  • Chapman RF, Laymon AS, Levine BD. Timing of arrival and pre-acclimatization strategies for the endurance athlete competing at moderate to high altitudes. High Alt Med Biol. 2013 Dec;14(4):319-24. doi: 10.1089/ham.2013.1022.

    PMID: 24377334BACKGROUND
  • Chapman RF, Stager JM, Tanner DA, Stray-Gundersen J, Levine BD. Impairment of 3000-m run time at altitude is influenced by arterial oxyhemoglobin saturation. Med Sci Sports Exerc. 2011 Sep;43(9):1649-56. doi: 10.1249/MSS.0b013e318211bf45.

    PMID: 21311361BACKGROUND
  • Chapman RF, Stickford JL, Levine BD. Altitude training considerations for the winter sport athlete. Exp Physiol. 2010 Mar;95(3):411-21. doi: 10.1113/expphysiol.2009.050377. Epub 2009 Oct 16.

    PMID: 19837773BACKGROUND
  • Coles MG, Luetkemeier MJ. Sodium-facilitated hypervolemia, endurance performance, and thermoregulation. Int J Sports Med. 2005 Apr;26(3):182-7. doi: 10.1055/s-2004-820989.

    PMID: 15776333BACKGROUND
  • Coyle EF, Hopper MK, Coggan AR. Maximal oxygen uptake relative to plasma volume expansion. Int J Sports Med. 1990 Apr;11(2):116-9. doi: 10.1055/s-2007-1024774.

    PMID: 1692570BACKGROUND
  • Fortney SM, Wenger CB, Bove JR, Nadel ER. Effect of blood volume on forearm venous and cardiac stroke volume during exercise. J Appl Physiol Respir Environ Exerc Physiol. 1983 Sep;55(3):884-90. doi: 10.1152/jappl.1983.55.3.884.

    PMID: 6629925BACKGROUND
  • Fulco CS, Muza SR, Beidleman BA, Demes R, Staab JE, Jones JE, Cymerman A. Effect of repeated normobaric hypoxia exposures during sleep on acute mountain sickness, exercise performance, and sleep during exposure to terrestrial altitude. Am J Physiol Regul Integr Comp Physiol. 2011 Feb;300(2):R428-36. doi: 10.1152/ajpregu.00633.2010. Epub 2010 Dec 1.

    PMID: 21123763BACKGROUND
  • Fulco CS, Rock PB, Cymerman A. Maximal and submaximal exercise performance at altitude. Aviat Space Environ Med. 1998 Aug;69(8):793-801.

    PMID: 9715971BACKGROUND
  • Gillen CM, Lee R, Mack GW, Tomaselli CM, Nishiyasu T, Nadel ER. Plasma volume expansion in humans after a single intense exercise protocol. J Appl Physiol (1985). 1991 Nov;71(5):1914-20. doi: 10.1152/jappl.1991.71.5.1914.

    PMID: 1761491BACKGROUND
  • Gillen CM, Nishiyasu T, Langhans G, Weseman C, Mack GW, Nadel ER. Cardiovascular and renal function during exercise-induced blood volume expansion in men. J Appl Physiol (1985). 1994 Jun;76(6):2602-10. doi: 10.1152/jappl.1994.76.6.2602.

    PMID: 7928889BACKGROUND
  • Greenleaf JE, Looft-Wilson R, Wisherd JL, Jackson CG, Fung PP, Ertl AC, Barnes PR, Jensen CD, Whittam JH. Hypervolemia in men from fluid ingestion at rest and during exercise. Aviat Space Environ Med. 1998 Apr;69(4):374-86.

    PMID: 9561285BACKGROUND
  • Gorini Pereira F, Greenfield AM, Kuennen M, Gillum TL. Exercise induced plasma volume expansion lowers cardiovascular strain during 15-km cycling time-trial in acute normobaric hypoxia. PLoS One. 2024 Feb 2;19(2):e0297553. doi: 10.1371/journal.pone.0297553. eCollection 2024.

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

April 6, 2023

Study Start

January 15, 2019

Primary Completion

December 15, 2019

Study Completion

December 8, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations