- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06467656
The UBC Long-distance Triathlon Adaptation Study (ULTRA)
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neil Eves, PhD
- Phone Number: 250-807-9676
- Email: neil.eves@ubc.ca
Study Contact Backup
- Name: Robert Shave, PhD
- Phone Number: 250-317-7226
- Email: rob.shave@ubc.ca
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V1V7
- Recruiting
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Exercise Intervention Group
- Aged 19-39 years
- Non-smoker (quit >6 months)
- Able to swim >100 meters without stopping
- Have access to, or willingness, to obtain a road bicycle
- Are willing to commit to the research assessments and prescribed training program
- Currently performing <120 minutes of structured endurance training per week
- Premenopausal
Inclusion Criteria: Control Group
- Aged 19-39 years
- Non-smoker (quit >6 months)
- Are willing to commit to the research assessments
- Currently performing <120 minutes of structured endurance training per week
- Premenopausal
Exclusion Criteria: Exercise Intervention Group and Control Group:
- History of heart disease
- History of lung disease (not including controlled asthma)
- History of metabolic disease
- History of cancer
- Chronic inflammatory conditions
- Blood pressure > 140/90 mmHg
- Chronic antibiotic, antiviral, antimicrobial, non-steroidal anti-inflammatory drugs (NSAIDs) and antihistamine use
- Are a regular (more than 1/week) cannabis user
- Consume alcohol regularly: more than 6 standard drinks per week (e.g.14-20 ounces of beer and 5-8 ounces of wine)
- Have previously completed structured endurance exercise training for an extended period of time (such as training for a triathlon or running race)
- Have previously participated in competitive team sports with an aerobic component (e.g. soccer, basketball, rugby, field hockey) and sport-specific training (e.g. hockey, football) >3 times per week within the previous 5 years
- Have prior experience of heavy structured resistance training >3x/week within the last 2 years
- BMI>32 kg/m2 or <20 kg/m2
- Pregnancy within 12 months, or planning to become pregnant within the next 12 months
- Currently breast feeding (or having stopped within 6 months)
- Planning to be away from the Okanagan area for an extended period over the duration of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Intervention
Participants will engage in 12 months of individualized endurance-training (swimming, cycling and running) and 9 months of supplemental strengthening exercises.
Exercise prescriptions will be provided to participants weekly via an app (TrainingPeaks).
Sessions will vary in length from 30 min to 8 hours throughout the program.
|
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.
|
|
Active Comparator: Time-Aligned Control
Participants in the control arm will continue to live their lives exactly as they would if they were not enrolled in a study to allow evaluation of natural biological changes that occur across 12-months of free-living.
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Participants will receive no specific intervention and will continue to live their lives as if they were not in a study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal oxygen consumption (VO2max).
Time Frame: 12 Months
|
The change in VO2max from baseline to 12 months of exercise training.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-course of change in VO2max.
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.
|
3, 6, and 12 months
|
|
Time-course of change in resting left ventricular structure.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left ventricular structure during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left ventricular structure with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in ventricular diameter to wall thickness
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left ventricular mass
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting right ventricular structure.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular structure during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular structure with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting left atrial structure.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left atrial structure during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left atrial structure with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting left ventricular function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left ventricular function during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left ventricular function with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting left ventricular diastolic function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting right ventricular function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular function during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular function with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting right ventricular strain.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular strain during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in right ventricular strain with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting left-atrial strain
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in left-atrial strain during exercise.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in in left-atrial strain with volume loading.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in p-wave duration.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in p-wave amplitude
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in p wave root mean square average
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.
|
1, 3, 6, and 12 months
|
|
Relationships between changes in cardiac electrical activity and left atrial volume.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in blood volume.
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.
|
1, 3, 6, and 12 months
|
|
Relationship between changes in blood volume and cardiac structure
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in resting upper body vascular structure.
Time Frame: 1, 3, 6, and 12 months
|
The time-course of change in upper body macrovascular structure by resting brachial artery diameter.
|
1, 3, 6, and 12 months
|
|
Time-course of change in upper body vascular structure.
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.
|
1, 3, 6, and 12 months
|
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Time-course of change in resting lower body vascular structure.
Time Frame: 1, 3, 6, and 12 months
|
The time-course of change in lower body macrovascular structure by resting superficial femoral artery diameter.
|
1, 3, 6, and 12 months
|
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Time-course of change in upper body microvascular structure.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in upper body vascular function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in lower body vascular function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in upper body microvascular function
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in lower body microvascular function.
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.
|
1, 3, 6, and 12 months
|
|
Time-course of change in arterial stiffness.
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.
|
1, 3, 6, and 12 months
|
|
Change in exercising ventilatory reserve
Time Frame: 12 months
|
Change in ventilatory reserve (maximum ventilation / ventilatory capacity) from baseline to 12 months of exercise training.
|
12 months
|
|
Change in expiratory flow limitation.
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.
|
12 months
|
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Change in work of breathing.
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.
|
12 months
|
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Change in ventilatory efficiency.
Time Frame: 12 months
|
Change in ventilatory efficiency (assessed by VE-VCO2 slope during graded exercise) from baseline to 12 months of exercise training.
|
12 months
|
|
Change in lung volume.
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.
|
12 months
|
|
Change in dyspnea.
Time Frame: 12 months
|
Change in dyspnea (assessed via modified Borg scale) during intensity-matched exercise from baseline to 12 months of exercise training.
|
12 months
|
|
Time course of change in exercising ventilatory reserve
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.
|
3, 6, and 12 months
|
|
Time course of change in expiratory flow limitation.
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.
|
3, 6, and 12 months
|
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Time course of change in work of breathing.
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.
|
3, 6, and 12 months
|
|
Time course of change in ventilatory efficiency.
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.
|
3, 6, and 12 months
|
|
Time course of change in lung volume.
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.
|
3, 6, and 12 months
|
|
Time course of change in dyspnea.
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.
|
3, 6, and 12 months
|
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Time course of change in chemoreflex sensitivity.
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.
|
3, 6, and 12 months
|
|
Gut microbiome composition and diversity.
Time Frame: 1,3, 6, and 12 months
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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.
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1,3, 6, and 12 months
|
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Innate immune reprogramming.
Time Frame: 12 months
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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.
|
12 months
|
|
Innate immune memory.
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.
|
15 months
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Affective response.
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.
|
12 months
|
|
Affective processing.
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.
|
12 months
|
|
Time course of change in blood lactate.
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.
|
3, 6, and 12 months
|
|
Time course of change in heart rate.
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.
|
3, 6, and 12 months
|
|
Time course of change in perceived exertion.
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
|
3, 6, and 12 months
|
|
Sex-difference in physiological adaptation.
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.
|
1,3, 6, 12 and 15 months where applicable
|
|
Relationships between gut microbiome and exercise performance
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.
|
1,3, 6, and 12 months
|
|
Relationships between gut microbiome and cardio metabolic health
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.
|
1,3, 6, and 12 months
|
|
Relationships between affective responses, affective processing and other exercise and psychological variables.
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Shave, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H24-00882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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PfizerCompletedHealthy Subjects | Healthy ParticipantsUnited States
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Hoffmann-La RocheNot yet recruiting
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Simcere Pharmaceutical Co., LtdNot yet recruiting
Clinical Trials on Individualized, periodized endurance training for ultra-endurance triathlon.
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Riphah International UniversityCompletedDiabetes Mellitus, Type 2Pakistan
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Hasselt UniversityCompletedMultiple SclerosisBelgium