NCT06740136

Brief Summary

The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2023

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

December 10, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

Muscle damageSingle nucleotide polymorphismexercise

Outcome Measures

Primary Outcomes (1)

  • The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation

    Association between blood creatine kinase level variations and single nucleotide polymorphisms. The Outcome Measure in this study is focused on the variation in plasma CPK levels following an exercise inducing muscle damage. The result is expressed as a change in plasma CPK concentration, measured in units per liter (U/L). This single measurement is used to investigate its association with genetic polymorphisms. Therefore a regression analysis will be performed to identify the association. This study is exploratory and the genetic polymorphisms are not pre-identified but will be investigated through a comprehensive analysis.

    Evolution of kinetics from Day 0 to Day 3 post experiment

Study Arms (1)

Exercise

EXPERIMENTAL

exercise group

Other: Exercise

Interventions

Muscle induced-damage eccentric exercise

Exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged between 18 and 35
  • Weighing more than 50 kg
  • Member of a sports club affiliated to an Olympic federation
  • Socially insured
  • Willing to comply with all study procedures and duration of the study

You may not qualify if:

  • Medical history contraindicating sporting activities
  • Current medical treatment
  • Not a member of a sports club affiliated to an Olympic federation
  • Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasport

Loos, 59120, France

RECRUITING

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Intervention model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 18, 2024

Study Start

March 13, 2023

Primary Completion

June 28, 2024

Study Completion

December 19, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations