Clinical trial NCT06467656: The UBC Long-distance Triathlon Adaptation Study
Official title: The UBC Long-distance Triathlon Adaptation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Participants
Keywords: Exercise
Endurance training
Cardiorespiratory fitness
Cardiovascular
Respiratory
Vascular
Immune
Microbiome
Psychology
Performance
Biological Sex Differences
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel group, non-randomized study.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Maximal oxygen consumption (VO2max).
timeFrame: 12 Months
Secondary outcomes:
measure: Time-course of change in VO2max.
timeFrame: 3, 6, and 12 months
measure: Time-course of change in resting left ventricular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left ventricular structure during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left ventricular structure with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in ventricular diameter to wall thickness
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left ventricular mass
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting right ventricular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular structure during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular structure with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting left atrial structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left atrial structure during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left atrial structure with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting left ventricular function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left ventricular function during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left ventricular function with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting left ventricular diastolic function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting right ventricular function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular function during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular function with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting right ventricular strain.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular strain during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in right ventricular strain with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting left-atrial strain
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in left-atrial strain during exercise.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in in left-atrial strain with volume loading.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in p-wave duration.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in p-wave amplitude
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in p wave root mean square average
timeFrame: 1, 3, 6, and 12 months
measure: Relationships between changes in cardiac electrical activity and left atrial volume.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in blood volume.
timeFrame: 1, 3, 6, and 12 months
measure: Relationship between changes in blood volume and cardiac structure
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting upper body vascular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in upper body vascular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in resting lower body vascular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in upper body microvascular structure.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in upper body vascular function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in lower body vascular function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in upper body microvascular function
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in lower body microvascular function.
timeFrame: 1, 3, 6, and 12 months
measure: Time-course of change in arterial stiffness.
timeFrame: 1, 3, 6, and 12 months
measure: Change in exercising ventilatory reserve
timeFrame: 12 months
measure: Change in expiratory flow limitation.
timeFrame: 12 months
measure: Change in work of breathing.
timeFrame: 12 months
measure: Change in ventilatory efficiency.
timeFrame: 12 months
measure: Change in lung volume.
timeFrame: 12 months
measure: Change in dyspnea.
timeFrame: 12 months
measure: Time course of change in exercising ventilatory reserve
timeFrame: 3, 6, and 12 months
measure: Time course of change in expiratory flow limitation.
timeFrame: 3, 6, and 12 months
measure: Time course of change in work of breathing.
timeFrame: 3, 6, and 12 months
measure: Time course of change in ventilatory efficiency.
timeFrame: 3, 6, and 12 months
measure: Time course of change in lung volume.
timeFrame: 3, 6, and 12 months
measure: Time course of change in dyspnea.
timeFrame: 3, 6, and 12 months
measure: Time course of change in chemoreflex sensitivity.
timeFrame: 3, 6, and 12 months
measure: Gut microbiome composition and diversity.
timeFrame: 1,3, 6, and 12 months
measure: Relationships between gut microbiome and exercise performance
timeFrame: 1,3, 6, and 12 months
measure: Relationships between gut microbiome and cardio metabolic health
timeFrame: 1,3, 6, and 12 months
measure: Innate immune reprogramming.
timeFrame: 12 months
measure: Innate immune memory.
timeFrame: 15 months
measure: Affective response.
timeFrame: 12 months
measure: Affective processing.
timeFrame: 12 months
measure: Relationships between affective responses, affective processing and other exercise and psychological variables.
timeFrame: 12 months
measure: Time course of change in blood lactate.
timeFrame: 3, 6, and 12 months
measure: Time course of change in heart rate.
timeFrame: 3, 6, and 12 months
measure: Time course of change in perceived exertion.
timeFrame: 3, 6, and 12 months
measure: Sex-difference in physiological adaptation.
timeFrame: 1,3, 6, 12 and 15 months where applicable
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Robert Shave, PhD
role: PRINCIPAL_INVESTIGATOR
References: