NCT06467656

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

May 22, 2024

Last Update Submit

April 2, 2025

Conditions

Keywords

ExerciseEndurance trainingCardiorespiratory fitnessCardiovascularRespiratoryVascularImmuneMicrobiomePsychologyPerformanceBiological Sex Differences

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen consumption (VO2max).

    The change in VO2max from baseline to 12 months of exercise training.

    12 Months

Secondary Outcomes (65)

  • Time-course of change in VO2max.

    3, 6, and 12 months

  • Time-course of change in resting left ventricular structure.

    1, 3, 6, and 12 months

  • Time-course of change in left ventricular structure during exercise.

    1, 3, 6, and 12 months

  • Time-course of change in left ventricular structure with volume loading.

    1, 3, 6, and 12 months

  • Time-course of change in ventricular diameter to wall thickness

    1, 3, 6, and 12 months

  • +60 more secondary outcomes

Study Arms (2)

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.

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.

Other: Time-Aligned Control

Interventions

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.

Exercise Intervention

Participants will receive no specific intervention and will continue to live their lives as if they were not in a study.

Time-Aligned Control

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V1V7, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Robert Shave, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Shave, PhD

CONTACT

Neil Eves, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This will be a parallel group, non-randomized study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 21, 2024

Study Start

June 20, 2024

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Ongoing from 6 months after publication

Locations