Healthy ParticipantsULTRANCT06467656
The UBC Long-distance Triathlon Adaptation Study
A study testing Individualized, periodized endurance training for ultra-endurance triathlon. in people with Healthy Participants, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Individualized, periodized endurance training for ultra-endurance triathlon.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2024to 18 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 29Show fewer
- Premenopausal
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Healthy Participants
- Being tested
- Individualized, periodized endurance training for ultra-endurance triathlon., Time-Aligned Control
- Keywords
- Exercise, Endurance training, Cardiorespiratory fitness, Cardiovascular, Respiratory, Vascular, Immune, Microbiome, Psychology, Performance, Biological Sex Differences
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized, periodized endurance training for ultra-endurance triathlon.Other
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.
Time-Aligned ControlOther
Participants will receive no specific intervention and will continue to live their lives as if they were not in a study.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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. Receives: Other: Individualized, periodized endurance training for ultra-endurance triathlon. |
| Time-Aligned Control | Active comparator | 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. Receives: Other: Time-Aligned Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption (VO2max).
The change in VO2max from baseline to 12 months of exercise training.
Measured: 12 Months
Secondary outcomes (65)
Time-course of change in VO2max.
The time-course of change in VO2max from baseline to 3, 6, and 12 months of exercise training.
Measured: 3, 6, and 12 months
Time-course of change in resting left ventricular structure.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left ventricular structure during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left ventricular structure with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in ventricular diameter to wall thickness
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left ventricular mass
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting right ventricular structure.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular structure during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular structure with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting left atrial structure.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left atrial structure during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left atrial structure with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting left ventricular function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left ventricular function during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left ventricular function with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting left ventricular diastolic function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting right ventricular function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular function during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular function with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting right ventricular strain.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular strain during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in right ventricular strain with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting left-atrial strain
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in left-atrial strain during exercise.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in in left-atrial strain with volume loading.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in p-wave duration.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in p-wave amplitude
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in p wave root mean square average
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.
Measured: 1, 3, 6, and 12 months
Relationships between changes in cardiac electrical activity and left atrial volume.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in blood volume.
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.
Measured: 1, 3, 6, and 12 months
Relationship between changes in blood volume and cardiac structure
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting upper body vascular structure.
The time-course of change in upper body macrovascular structure by resting brachial artery diameter.
Measured: 1, 3, 6, and 12 months
Time-course of change in upper body vascular structure.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in resting lower body vascular structure.
The time-course of change in lower body macrovascular structure by resting superficial femoral artery diameter.
Measured: 1, 3, 6, and 12 months
Time-course of change in upper body microvascular structure.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in upper body vascular function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in lower body vascular function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in upper body microvascular function
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in lower body microvascular function.
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.
Measured: 1, 3, 6, and 12 months
Time-course of change in arterial stiffness.
Central arterial stiffness (carotid-femoral pulse wave velocity) from baseline to 1,3,6 and 12 months of exercise training.
Measured: 1, 3, 6, and 12 months
Change in exercising ventilatory reserve
Change in ventilatory reserve (maximum ventilation / ventilatory capacity) from baseline to 12 months of exercise training.
Measured: 12 months
Change in expiratory flow limitation.
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.
Measured: 12 months
Change in work of breathing.
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.
Measured: 12 months
Change in ventilatory efficiency.
Change in ventilatory efficiency (assessed by VE-VCO2 slope during graded exercise) from baseline to 12 months of exercise training.
Measured: 12 months
Change in lung volume.
Change in operational lung volumes (assessed via IC maneuvers) during intensity-matched exercise from baseline to 12 months of exercise training.
Measured: 12 months
Change in dyspnea.
Change in dyspnea (assessed via modified Borg scale) during intensity-matched exercise from baseline to 12 months of exercise training.
Measured: 12 months
Time course of change in exercising ventilatory reserve
Time course of change in ventilatory reserve (maximum ventilation / ventilatory capacity) from baseline to 3, 6, and 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in expiratory flow limitation.
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.
Measured: 3, 6, and 12 months
Time course of change in work of breathing.
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.
Measured: 3, 6, and 12 months
Time course of change in ventilatory efficiency.
Time course of change in ventilatory efficiency (assessed by VE-VCO2 slope during graded exercise) from baseline to 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in lung volume.
Time course of change in operational lung volumes (assessed via IC maneuvers) during intensity-matched exercise from baseline to 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in dyspnea.
Time course of change in dyspnea (assessed via modified Borg scale) during intensity-matched exercise from baseline to 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in chemoreflex sensitivity.
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.
Measured: 3, 6, and 12 months
Gut microbiome composition and diversity.
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.
Measured: 1,3, 6, and 12 months
Relationships between gut microbiome and exercise performance
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.
Measured: 1,3, 6, and 12 months
Relationships between gut microbiome and cardio metabolic health
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.
Measured: 1,3, 6, and 12 months
Innate immune reprogramming.
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.
Measured: 12 months
Innate immune memory.
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.
Measured: 15 months
Affective response.
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.
Measured: 12 months
Affective processing.
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.
Measured: 12 months
Relationships between affective responses, affective processing and other exercise and psychological variables.
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.
Measured: 12 months
Time course of change in blood lactate.
Change in blood lactate (fingertip lactate) during sustained moderate-high intensity exercise from baseline to 3, 6, and 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in heart rate.
Change in heart rate (telemetry) during sustained moderate-high intensity exercise from baseline to 3, 6, and 12 months of exercise training.
Measured: 3, 6, and 12 months
Time course of change in perceived exertion.
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
Measured: 3, 6, and 12 months
Sex-difference in physiological adaptation.
Sex-differences in the time course of change in physiological parameters associated with the primary and secondary outcomes.
Measured: 1,3, 6, 12 and 15 months where applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start20 Jun 2024
- Primary completion22 Sep 2025
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel group, non-randomized study.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Shave, University of British Columbia
- Investigators
- Robert Shave, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467656
- Sponsor's protocol ID
- H24-00882
- Acronym
- ULTRA
- Status last verified
- Jun 2026
- First submitted
- 22 May 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for deidentified individual participant data can be made 6 months following publication. Deidentified individual participant data reported in manuscripts will be shared but may need a data sharing agreement in place between UBC and the institution of the requester.