Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06145152
Other study ID # Ellida
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 5, 2023
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source The Swedish School of Sport and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - Heart, lung or metabolic disease - Recurrent running injuries - Not willing to use wearable devices - Performing a subtantial amount of non-running exercise training

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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)
Static exercise training
The training recommendation for the day will not be adjusted based on the readiness level.

Locations

Country Name City State
Sweden Swedish School of Sports and Health Sciences Stockholm

Sponsors (2)

Lead Sponsor Collaborator
The Swedish School of Sport and Health Sciences Silicon Valley Exercise Analytics (svexa)

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical performance 3000 meter time trial performance pre intervention and within 5 days post intervention
Secondary Maximal oxygen consumption maximal oxygen consumption at the end of an incremental exercise stress test pre intervention and within 5 days post intervention
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT04788251 - Falls Prevention Evaluation and Development for Older Adults in the Community N/A
Completed NCT04563585 - Position Differences and Physical Performance Among Female Team Handball Players
Completed NCT04496700 - Transfusion of Whole Blood to Military Forces in a Combat Situation N/A
Not yet recruiting NCT05544955 - Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Completed NCT05078138 - Impact of Erythropoietin on Hematological Adaptations and Physical Performance Phase 4
Completed NCT04404413 - High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women N/A
Completed NCT05205278 - Effect of Progressive Isolated Core Stability Training N/A
Terminated NCT01523600 - Whole Body Vibration Training Among Older People Using Sheltered Housing Phase 4
Recruiting NCT04863469 - Brain-Physical Optimization Conditioning N/A
Completed NCT06391606 - CoQ10 in Statin-associated Asthenia N/A
Active, not recruiting NCT03359083 - Relationship Between Foot-ankle Characteristics and Lumbopelvic Control, Balance and Physical Performance N/A
Completed NCT04162886 - Effects of Exercises on Physical Performance N/A
Not yet recruiting NCT05609851 - Relationship Occupation and Physical Performance in Elderly
Completed NCT06354725 - Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions N/A
Completed NCT03449992 - The Effects of Nitrate Supplementation on Elite Runners N/A
Completed NCT04272164 - Weighted Rope Training in Taekwando Athletes N/A
Completed NCT05219344 - Tissue Flossing and Lower Limb Neuromuscular Function N/A
Completed NCT03133364 - Developing and Testing Delicious and Nutritious for the Old People N/A
Active, not recruiting NCT05232669 - COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance N/A