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Completed

NCT Number: NCT05800808

Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain

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.

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Key information

Age range

18 year–38 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

California Baptist University

Riverside, California, 92504-3206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

High Intensity Intervals

Procedure

8x4 min cycling bouts at 85% of VO2peak

moderate exercise

Procedure

81 minutes of cycling at 50% VO2peak

Primary outcomes

  1. Hemoglobin Concentration

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

    measured through spectroscopy

  2. Hematocrit Concentration

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

    measured through hematocrit reader

Secondary outcomes

  1. Time Trial Time

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

    Time to complete 15 km

  2. Cardiac Output

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

    measured via impedance cardiography

Sponsors and collaborators

Lead sponsor

California Baptist University

Other

Collaborators

  • High Point University
  • United States Army Research Institute of Environmental Medicine

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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