Importance of Blood Volume and Its Interaction With Cardiovascular Adaptations
1 other identifier
interventional
36
1 country
2
Brief Summary
The present project aims to investigate the interaction between training-induced blood volume expansion (plasma- and red blood cell volume responses), central as well as peripheral cardio-vascular adaptations. We will investigate cardiovascular responses through one year of training in recreationally active men and women as well as endurance athletes undertaking shorter training-periods/interventions with environmental heat-stress. The overall purpose with the project is to investigate the physiological effects of prolonged aerobic exercise on central cardiovascular parameters and peripheral effects in the muscle tissue in untrained individuals. Further, we want to compare these effects to exposure to environmental stress (heat) on performance well trained individuals. The present study consist of three parts using the same methodology in different populations to elucidate the above mentioned mechanisms. The first part is a larger training intervention in untrained/recreationally active men and women aiming at evaluating the initial cardiovascular adaptations to an exercise training regimen. In addition there are two parts aimed to elucidate the mechanisms leading to further improvements in cardiovascular and blood volume adaptations from exercise training in a different environmental condition and artificially elevated PV in already highly adapted endurance athletes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2021
CompletedStudy Start
First participant enrolled
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedNovember 29, 2023
November 1, 2023
2.8 years
December 10, 2021
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Maximal systemic oxygen uptake
Training-induced changes in maximal systemic oxygen uptake (ml/min) is evaluated with an incremental maximal cycle protocol on a cycle ergometer
20 minutes
Resting and cycling stroke volume and function measured with echocardiography
LV stroke volume (ml) and LV basal and apical twist (Deg) will be used to measure training-induced changes in LV function during exercise
90 minutes
Change in vascular conductance of the brachial artery
Assessment of changes in arm vascular conductance (ml/min/mm/Hg/kg arm mass) to flow mediated dilation, infusion of Acetylcholine and sodium nitroprusside, assessed by ultrasound Doppler.
2 hours
Blood volume
Training-induced changes in total blood volume (mL) is measured using the Carbon-monoxide rebreathing method.
20 minutes
Secondary Outcomes (4)
Mitochondrial biogenesis
60 minutes
Fat mass
20 minutes
Fat free mass
20 minutes
Cardiac dimentions
90 minutes
Study Arms (2)
Blood volume interactions with cardiovascular adaptations
ACTIVE COMPARATORIndividual differences in the time course and relationship between cardiovascular (central and peripheral) adaptations to long-term aerobic training and the concomitant blood volume changes.
Sex differences
ACTIVE COMPARATOREvaluate differences between genders and hormonal factors influencing individual differences (high vs. low responders) - hypothesizing that female have a blunted cardiovascular response to long-term aerobic training.
Interventions
Subjects participating in the current study will be trained progressively and intensively for 12 months primarily on bike indoors and outdoors
Eligibility Criteria
You may qualify if:
- absence of metabolic, chronic diseases, uncontrolled arrhythmia, 2. or 3. degree AV-block or sick sinus syndrome
- no history of smoking or alcohol consumption (≥ 14 items / week)
- decent acoustic window for echocardiography.
You may not qualify if:
- chronic disease or taking medication
- history of \>2 years of exercise training
- failure to meet exercise raining criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- University of Southern Denmarkcollaborator
Study Sites (2)
Department of Nutrition, Exercise and Sports
Copenhagen, 2100, Denmark
University of Copenhagen
Copenhagen, 2200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikolai B. Nordsborg, Prof.
University of Copenhagen - Department of Nutrition, Exercise and Sports
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2021
First Posted
January 14, 2022
Study Start
January 6, 2022
Primary Completion
November 1, 2024
Study Completion
November 1, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11