Clinical trial NCT05800808: Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain
Official title: Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain and Improves Cycling Time-trial Performance in Acute Normobaric Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output
Stroke Volume
Keywords: Hypervolemia
high intensity exercise
altitude exposure
Lead sponsor: California Baptist University
Sponsor class: OTHER
Collaborators: name: High Point University
name: United States Army Research Institute of Environmental Medicine
First posted: 2023-04-06
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin Concentration
timeFrame: through study completion, an average of 4 weeks
measure: Hematocrit Concentration
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
measure: Time Trial Time
timeFrame: through study completion, an average of 4 weeks
measure: Cardiac Output
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
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