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L'essai clinique NCT06145152 (ELLIDA) pour Maximal Oxygen Consumption, Performance physique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Adaptive Training Recommendations for Improved Physical Performance (ELLIDA)

En recrutement
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L'essai clinique NCT06145152 (ELLIDA) est conçu pour étudier la recherche fondamentale de Maximal Oxygen Consumption, Performance physique. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : en recrutement. L'essai a débuté le 5 décembre 2023 et vise à recruter 40 participants. Dirigé par The Swedish School of Sport and Health Sciences, l'essai devrait être terminé d'ici le 1 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 20 mars 2024.
Résumé succinct
In this study two different training strategies are compared; one is adaptive where the training is adjusted up or down on a daily basis to better match the recovery status (readiness) of the subject. The other strategy is static, i.e. no changes are made depending on readiness level. Instead the subjects in the static group are encouraged to perform the prescribed training.

The training intervention will last for 8 weeks.

Thorough physiological tests will be performed pre and post the training intervention together with muscle biopsies for assessment of mitochondrial function.

Description détaillée
40 recreational athletes, 20 male and 20 females, will be recruited to this study. The research subjects will be stratified into two groups: an Adaptive and a Static training group. The training sessions will be mainly home-based training according to daily instructions from an online application. Testing sessions will be performed on a laboratory treadmill. During the entire period (run-in + training period) the participants will wear continuous glucose monitors for minute-by-minute glucose tracking, an Oura ring for sleep measurements, a Garmin GPS watch with heart rate chest-strap for training data and answer questiions regarding subjective well-being using an online application (Readiness Advisor).

The training program will be a mixture of training sessions based on the experience levels of the research subject.

During the onboarding session, data from each persons Garmin watch, will be used to create an optimal training program that takes into account recent training history and which type of training each subject responds the best to. For the subjects in the Adaptive group the training will be adjusted up or down on a daily basis based on subjective readiness, sleep or glucose control. The subjects in the Static group will not get any adjustments in their training program regardless of readiness level.

The length of the training intervention will be 8 weeks.

In addition to adjusting the training for the adaptive group based on daily readiness, the training in that group will be adjusted based on actual training done. For example if a participant fails to reach his suggested heart rate range during a prescribed session, the training load for upcoming sessions will be recalculated so that the weekly overall training load goal is achieved. This kind of adjustments will not be done in the static training group.

Both pre and post the training period a battery of physiological tests will be done including determination of VO2max, lactate threshold and running economy. A performance test (3000m time-trial) will be done on a running track.

A muscle biopsy will be donated from the Vastus Lateralis for assessment of mitochondrial function, efficiency, capacity and density using a combination of methods including respirometry, western blot and enzymatic methods. Capillarization and number of myonuclei will be assessed using histochemical staining. In addition muscle buffering capacity will be investigated using an acid-titration assay.

In addition to the physiological and biochemical investigation, parameters such as subjective training tolerability, perceived pleasure of the training and number of dropouts are important objectives in the proposed studie.

Statistical power calculation. Based on the parallel group design, 80% power, an alpha of 0.05 and a coefficient of variation of 2.4% for VO2max, 4.2% for performance and 14% for mitochondrial function, a differences can be detected between groups of 6%, 11% and 26% for the three outcomes if 15 participants per group are included. 20 subjects will be recruited per group to allow for 5 dropouts per group.

Titre officiel

Using AI-generated Adaptive Training Recommendations to Improve Physical Performance

Conditions
Maximal Oxygen ConsumptionPerformance physique
Autres identifiants de l'essai
  • ELLIDA
  • Ellida
Numéro NCT
Date de début (réel)
2023-12-05
Dernière mise à jour publiée
2024-03-20
Date de fin (estimée)
2025-12-01
Inscription (estimée)
40
Type d'essai
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
exercise
AI
Objectif principal
Recherche fondamentale
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalAdaptive
Subjects in the Adaptive group will get updated and adjusted training programs based on daily readiness level
Adaptive Exercise Training
The training recommendation for the day will be adjusted based on the readiness level. The adjustments can be both up or down (increased or decreased training)
Comparateur actifStatic
Subjects in the Static group will get the same inital training program as the Adaptive group but will not get updated and adjusted training programs based on daily readiness level
Static Exercise Training
The training recommendation for the day will not be adjusted based on the readiness level.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Physical performance
3000 meter time trial performance
pre intervention and within 5 days post intervention
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Maximal oxygen consumption
maximal oxygen consumption at the end of an incremental exercise stress test
pre intervention and within 5 days post intervention
Lactate threshold
lactate threshold (anaerobic threshold) as assessed by blood lactate concentration during a submaximal running test on the treadmill
pre intervention and within 5 days post intervention
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • Training history of at least two running sessions per week (5km +) the last 6 months
  • No chronic diseases
  • Able to perform maximal exercise
  • Having used a smart watch for training frequently during the last 3 months
  • Willing to use wearable technology (Oura ring, continuous glucose monitor, running GPS watch)

  • Heart, lung or metabolic disease
  • Recurrent running injuries
  • Not willing to use wearable devices
  • Performing a subtantial amount of non-running exercise training
The Swedish School of Sport and Health Sciences logoThe Swedish School of Sport and Health Sciences
Silicon Valley Exercise Analytics (svexa) logoSilicon Valley Exercise Analytics (svexa)
Partie responsable de l'essai
Filip Larsen, Investigateur principal, Associate Professor, The Swedish School of Sport and Health Sciences
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Swedish School of Sports and Health Sciences, Stockholm, 114 86, Sweden
Filip Larsen, PhD, Contact, +46(8)120 537 97, [email protected]
En recrutement