NCT05191979

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Completed
27 days until next milestone

Study Start

First participant enrolled

January 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

December 10, 2021

Last Update Submit

November 28, 2023

Conditions

Keywords

Blood volumeCardiac functionVascular functionPhysiological Effects of Long-term exercise trainingMitochondrial function

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 COMPARATOR

Individual differences in the time course and relationship between cardiovascular (central and peripheral) adaptations to long-term aerobic training and the concomitant blood volume changes.

Other: Exercise regiment (aerobic exercise on bike)

Sex differences

ACTIVE COMPARATOR

Evaluate 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.

Other: Exercise regiment (aerobic exercise on bike)

Interventions

Subjects participating in the current study will be trained progressively and intensively for 12 months primarily on bike indoors and outdoors

Blood volume interactions with cardiovascular adaptationsSex differences

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (2)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location

University of Copenhagen

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nikolai B. Nordsborg, Prof.

    University of Copenhagen - Department of Nutrition, Exercise and Sports

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Non-blinded, non-randomized intervention design
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

Locations