University of British Columbia
Kelowna, British Columbia, V1V1V7, Canada
NCT Number: NCT06467656
The purpose of this study is to investigate the effect of 12-months of individualized endurance-training (swimming, cycling and running) on physiological and psychological adaptations in exercise naïve individuals. Due to the potential seasonal changes that naturally occur in individuals across a year (even without training) the investigators will also compare the exercise-trained group to a time-aligned control group.
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Notify Me19 year–39 year
All sexes
Interventional
Not applicable
Kelowna, British Columbia, V1V1V7, Canada
Endurance training is well-accepted to lead to numerous positive physiological and psychological adaptations. However, many of the previous studies examining the benefits of endurance exercise on the human body have: 1) compared athletes with non-athletes using a cross-sectional design, 2) have employed training studies that are relatively short (e.g. weeks to months) in duration, 3) have primarily focused on male participants and not examined potential sex-differences, and 4) have not specifically recruited exercise naïve participants, as often participants are already engaged in ongoing recreational or competitive activities at the time of recruitment. As such, we have a limited understanding of the true time-course of adaptations that occur in exercise naïve individuals in response to training, or how physiological and psychological adaptations change beyond 4-6 months, and whether there are sex-specific differences in these adaptations.
This study is primarily designed to determine the time-course of adaptation and remodeling in females and males across multiple different physiological systems (i.e. cardiac, vascular, metabolic, respiratory, immune, and microbiome) and psychological measures at rest and in response to a range of provocations.
Forty healthy exercise-training naïve individuals (20 females: 20 males) will perform 12-months of individually prescribed, endurance training (including supplementary strengthening exercise for conditioning and injury prevention) designed to prepare participants for an ultra-endurance triathlon. A time-aligned control group of 20 healthy exercise-training naïve individuals (10 females: 10 males) will also be recruited to determine the natural change that occurs in each system across a year. Outcomes will be assessed at baseline, 3 months, 6 months and 12 months. Additionally, cardiovascular outcomes will also be assessed at 1 month and immune outcomes will be repeated at 3 months post intervention (15 months).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exercise Intervention Group
Inclusion criteria
Control Group
Exclusion criteria
Exercise Intervention Group and Control Group:
Endurance exercise consisting of swimming, cycling and running training for a minimum of 3 hours /week up to a maximum of 20 hours/week with regular rest days and intensities being fluctuated throughout the program to optimize training stimulus and adaptation. Strengthening exercises to complement the aerobic training, enhance conditioning and prevent injury will also be performed 1-2 hours/week for the first 9-months of the program.
Participants will receive no specific intervention and will continue to live their lives as if they were not in a study.
Time frame: 12 Months
The change in VO2max from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
The time-course of change in VO2max from baseline to 3, 6, and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular end-diastolic volume (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular end-diastolic volume (via transthoracic echocardiography) during acute exercise from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular end-diastolic volume (via transthoracic echocardiography) in response to head down tilt from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in the ratio of ventricular diameter to ventricular wall thickness (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular mass (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular area (via transthoracic echocardiography) at rest, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular area (via transthoracic echocardiography) in response to exercise from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular area (via transthoracic echocardiography) in response to head-down tilt from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in resting left atrial phasic volumes (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left atrial phasic volumes (via transthoracic echocardiography) in response to exercise from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left atrial phasic volumes (via transthoracic echocardiography) in response to head-down tilt from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular stroke volume (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular stroke volume (via transthoracic echocardiography) in response to acute exercise from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left ventricular stroke volume (via transthoracic echocardiography) in response to head-down tilt from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in the ratio of early to late left ventricular filling velocities (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular fractional area change (via transthoracic echocardiography) at rest, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular fractional area change (via transthoracic echocardiography) in response to acute exercise, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular fractional area change (via transthoracic echocardiography) in response to head down tilt, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular longitudinal strain (via transthoracic echocardiography) at rest, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular longitudinal strain (via transthoracic echocardiography) in response to acute exercise, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in right ventricular longitudinal strain (via transthoracic echocardiography) in response to head down tilt, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left atrial phasic strain (via transthoracic echocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left atrial phasic strain (via transthoracic echocardiography) in response to acute exercise, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in left atrial phasic strain (via transthoracic echocardiography) in response to head down tilt, from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in p wave duration (by 12-lead electrocardiography and signal-averaged electrocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in p wave amplitude (by 12-lead electrocardiography and signal-averaged electrocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The time-course of change in p wave root mean square voltage (by signal-averaged electrocardiography) at rest from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The relationship between p wave duration (by 12-lead electrocardiography and signal-averaged electrocardiography), amplitude (by 12-lead electrocardiography and signal-averaged electrocardiography) and root mean square voltage (by signalaveraged electrocardiography) with left atrial volume (via transthoracic echocardiography) from baseline to 3, 6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in blood volume (using the carbon monoxide re-breathe technique) from baseline to 1, 3, 6 and 12 months of exercise-training and compared to the change in the time-aligned control group.
Time frame: 1, 3, 6, and 12 months
The relationship between changes in blood volume and changes in cardiac structure (left ventricular end diastolic volume, ratio of ventricular diameter to ventricular wall thickness, ventricular mass, right ventricular area, left atrial volume; via transthoracic echocardiography) and function (stroke volume, right ventricular fractional area change, ratio of early to late left ventricular filling velocities, left ventricular longitudinal strain and left atrial strain; via transthoracic echocardiography) from baseline to 1, 3, 6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in upper body macrovascular structure by resting brachial artery diameter.
Time frame: 1, 3, 6, and 12 months
The time-course of change in upper body macrovascular structure by maximal brachial artery diameter following ischemic hand-grip from baseline to 1,3, 6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in lower body macrovascular structure by resting superficial femoral artery diameter.
Time frame: 1, 3, 6, and 12 months
The time-course of change in upper body microvascular structure from the maximal hyperemic response to hand-grip ischemic exercise from baseline to 1,3, 6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in upper body macrovascular function by brachial artery flow mediated dilation from baseline to 1,3,6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in lower body macrovascular function by superficial femoral artery flow mediated dilation from baseline to 1,3,6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in upper body microvascular function by the brachial artery reactive hyperemia response from baseline to 1,3,6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
The time-course of change in lower body microvascular function by the superficial femoral artery reactive hyperemia response from baseline to 1,3,6 and 12 months of exercise training.
Time frame: 1, 3, 6, and 12 months
Central arterial stiffness (carotid-femoral pulse wave velocity) from baseline to 1,3,6 and 12 months of exercise training.
Time frame: 12 months
Change in ventilatory reserve (maximum ventilation / ventilatory capacity) from baseline to 12 months of exercise training.
Time frame: 12 months
Change in expiratory flow limitations (% overlap of the exercise flow-volume loop at max exercise with the maximum flow-volume envelope) from baseline to 12 months of exercise training.
Time frame: 12 months
Change in total work of breathing (measured as the combination of inspiratory resistive, inspiratory elastic, and expiratory resistive work of breathing assessed by modified Campbell diagram) at intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 12 months
Change in ventilatory efficiency (assessed by VE-VCO2 slope during graded exercise) from baseline to 12 months of exercise training.
Time frame: 12 months
Change in operational lung volumes (assessed via IC maneuvers) during intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 12 months
Change in dyspnea (assessed via modified Borg scale) during intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in ventilatory reserve (maximum ventilation / ventilatory capacity) from baseline to 3, 6, and 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in the expiratory flow limitation (% overlap of the exercise flow-volume loop at max exercise with the maximum flow-volume envelope) from baseline to 3, 6, and 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in total work of breathing (measured as the combination of inspiratory resistive, inspiratory elastic, and expiratory resistive work of breathing assessed by modified Campbell diagram) at intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in ventilatory efficiency (assessed by VE-VCO2 slope during graded exercise) from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in operational lung volumes (assessed via IC maneuvers) during intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in dyspnea (assessed via modified Borg scale) during intensity-matched exercise from baseline to 12 months of exercise training.
Time frame: 3, 6, and 12 months
Time course of change in chemoreflex sensitivity (ventilatory response to changes in inspired CO2 and O2) from baseline to 3, 6, and 12 months of exercise training.
Time frame: 1,3, 6, and 12 months
The time course of change in gut microbiome composition and diversity (microbial alpha and beta diversity by 16S rRNA gene sequencing or shotgun metagenomic sequencing), circulating metabolites [plasma short-chain fatty acids (SCFA) and trimethylamine N-oxide (TMAO) levels], and markers of inflammation (fecal calprotectin and plasma cytokines via ELISA) and gut permeability [plasma lipopolysaccharide (LPS) via ELISA] from baseline to 1, 3, 6 and 12 months of exercise training.
Time frame: 1,3, 6, and 12 months
The relationship (as assessed through regression analyses) between changes in the gut microbiome with improvements in exercise performance from baseline to 1, 3, 6 and 12 months of exercise training.
Time frame: 1,3, 6, and 12 months
The relationship (as assessed through regression analyses) between changes in the gut microbiome, microbiome-driven metabolites (SCFA and TMAO), markers of inflammation (fecal calprotectin and plasma cytokines), and indices of gut permeability (plasma LPS) relevant to cardiometabolic health from baseline to 1,3, 6 and 12 months of exercise training.
Time frame: 12 months
The change in epigenomic landscape and cell function (e.g., cytokine production, phagocytosis) of circulating monocytes from baseline to 12 months of exercise training and compared to the change in the time-aligned control group.
Time frame: 15 months
The change in epigenomic landscape and cell function (e.g., cytokine production, phagocytosis) of circulating monocytes from 12-month exercise training to 3 months post exercise cessation.
Time frame: 12 months
The time course of changes in affective responses specifically exercise valence and arousal that people experience while exercising using a 1-item affect grid from baseline to 12 months and compared to the change in the time-aligned control group.
Time frame: 12 months
The time course of changes in affective processing (i.e pleasure-displeasure, energy-tired, calmness-tension, attraction-antipathy, pride/honour-guilt/shame, empowerment-damage) that people experience from baseline to 12 months and compared to the change in the time-aligned control group.
Time frame: 12 months
The relationships (as assessed through regression analyses) between affective responses, affective processing, incidental affect, exercise identity, competence, and adherence behaviours as well as cardiopulmonary fitness.
Time frame: 3, 6, and 12 months
Change in blood lactate (fingertip lactate) during sustained moderate-high intensity exercise from baseline to 3, 6, and 12 months of exercise training.
Time frame: 3, 6, and 12 months
Change in heart rate (telemetry) during sustained moderate-high intensity exercise from baseline to 3, 6, and 12 months of exercise training.
Time frame: 3, 6, and 12 months
Change in rating of perceived exertion (modified Borg scale) during sustained moderate-high intensity exercise from baseline to 3, 6, and 12 months of exercise
Time frame: 1,3, 6, 12 and 15 months where applicable
Sex-differences in the time course of change in physiological parameters associated with the primary and secondary outcomes.
University of British Columbia
Other
Acronym: ULTRA
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