Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
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.
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:
NCT06467656
Study Brief:
Protocol Section:
NCT06467656