Cardiac OutputNCT05800808

Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain

A study testing High Intensity Intervals and Moderate Exercise in people with Cardiac Output and Stroke Volume, run by California Baptist University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 38 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cardiac Output, Stroke Volume
What is being tested?: High Intensity Intervals and Moderate Exercise
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2019to 8 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 38 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

California Baptist University
Riverside, California, 92504-3206

Other trials in United States

About this study

Official title: Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain and Improves Cycling Time-trial Performance in Acute Normobaric Hypoxia

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.

Read the detailed description

A crossover design was utilized to assess the effects of exercise-induced plasma volume expansion on cycling performance in hypoxia. All participants completed a high intensity (HI) bout and control (CON) intervention in a counterbalanced order. The HI bout consisted of 8x4min cycling bouts at 85% of VO2peak with 4 min rest between intervals. CON consisted of cycling at 50% VO2peak. Two 15 km, self-paced cycling time trials (TT) were performed before and after each training intervention. The first TT occurred 5 days before the training intervention (HI or CON) and the second TT occurred 48 hours post intervention. Interventions were separated by 14 days to ensure sufficient washout of any training effect as data have suggested retention of expanded plasma volume may last for 7-14 days. During washout, participants were instructed to continue their normal exercise routine.

The investigators hypothesized that a single HI session would increase plasma volume and attenuate cardiovascular strain during exercise in hypoxia, as evidenced by reductions in HR and elevations in SV and Q. Furthermore, the investigators hypothesized that these changes would contribute to a reduced time-to-completion in a 15 km, self-paced cycling TT.

Conditions: Cardiac Output, Stroke Volume
Being tested: High Intensity Intervals, Moderate Exercise
Keywords: Hypervolemia, high intensity exercise, altitude exposure
Medical subject headings: Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Intensity IntervalsProcedure or surgery
8x4 min cycling bouts at 85% of VO2peak
Moderate ExerciseProcedure or surgery
81 minutes of cycling at 50% VO2peak

Study groups in NCT05800808
Study group	Role	What they receive
High Intensity Exercise	Experimental	Vigorous cycling Receives: Procedure: High Intensity Intervals
Continuous Moderate Exercise	Active comparator	Leisurely cycling Receives: Procedure: Moderate Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin Concentration
measured through spectroscopy
Measured: through study completion, an average of 4 weeks
Hematocrit Concentration
measured through hematocrit reader
Measured: through study completion, an average of 4 weeks

Secondary outcomes (2)

Time Trial Time
Time to complete 15 km
Measured: through study completion, an average of 4 weeks
Cardiac Output
measured via impedance cardiography
Measured: through study completion, an average of 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20198 Dec 2022

First posted6 Apr 2023
Study start15 Jan 2019
Primary completion15 Dec 2019
Study completion8 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Cardiac OutputStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05800808
Sponsor's protocol ID: Plasma Volume and Hypoxia
Status last verified: Apr 2023
First submitted: 28 Feb 2023
Last updated: 6 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 6065055
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.
PubMed 28039191
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.
PubMed 16690793
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.
PubMed 17824822
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.
PubMed 24377334
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.
PubMed 21311361
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.
PubMed 19837773
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.
PubMed 15776333
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.
PubMed 1692570
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.
PubMed 6629925
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.
PubMed 21123763
Fulco CS, Rock PB, Cymerman A. Maximal and submaximal exercise performance at altitude. Aviat Space Environ Med. 1998 Aug;69(8):793-801.
PubMed 9715971
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.
PubMed 1761491
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.
PubMed 7928889
Greenleaf JE, Looft-Wilson R, Wisherd JL, Jackson CG, Fung PP, Ertl AC, Barnes PR, Jensen CD, Whittam JH; New Collective Author. Hypervolemia in men from fluid ingestion at rest and during exercise. Aviat Space Environ Med. 1998 Apr;69(4):374-86.
PubMed 9561285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Output trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain and Improves Cycling Time-trial Performance in Acute Normobaric Hypoxia
ClinicalTrials.gov ID: NCT05800808
Acronym / sponsor ID: Plasma Volume and Hypoxia
Conditions: Cardiac Output, Stroke Volume
Keywords: Hypervolemia, high intensity exercise, altitude exposure
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: California Baptist UniversityUniversity, hospital or other
Collaborators: High Point University, United States Army Research Institute of Environmental Medicine
Study start: 15 Jan 2019 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 8 Dec 2022 (actual)
First posted: 6 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

48 hours after the exercise, participants were again examined in hypoxia.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Intensity Exercise	Experimental	Procedure: High Intensity IntervalsVigorous cycling
Continuous Moderate Exercise	Active comparator	Procedure: Moderate ExerciseLeisurely cycling

Who may qualify

Ages: 18 to 38 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Intensity Intervals8x4 min cycling bouts at 85% of VO2peak	Procedure or surgery	High Intensity Exercise
Moderate Exercise81 minutes of cycling at 50% VO2peak	Procedure or surgery	Continuous Moderate Exercise

Primary outcome

Hemoglobin Concentration
Time frame: through study completion, an average of 4 weeks
measured through spectroscopy
Hematocrit Concentration
Time frame: through study completion, an average of 4 weeks
measured through hematocrit reader

2 secondary outcomes

Time Trial Time
Time frame: through study completion, an average of 4 weeks
Cardiac Output
Time frame: through study completion, an average of 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Background: PubMed 6065055Alexander 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.
Background: PubMed 28039191Beidleman 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.
Background: PubMed 16690793Berger 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.
Background: PubMed 17824822Brothers 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.
Background: PubMed 24377334Chapman 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.
Background: PubMed 21311361Chapman 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.
Background: PubMed 19837773Chapman 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.
Background: PubMed 15776333Coles 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.
Background: PubMed 1692570Coyle 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.
Background: PubMed 6629925Fortney 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.
Background: PubMed 21123763Fulco 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.
Background: PubMed 9715971Fulco CS, Rock PB, Cymerman A. Maximal and submaximal exercise performance at altitude. Aviat Space Environ Med. 1998 Aug;69(8):793-801.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Intervals and Moderate Exercise in people with Cardiac Output and Stroke Volume, run by California Baptist University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin Concentration (time frame: through study completion, an average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800808, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.