- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06193824
Ottimizzazione degli esercizi eccentrici (OPTIMEX)
Caratterizzazione della risposta endocrina all'esercizio: impatto della modalità di contrazione muscolare
Regular physical activity is an important public health lever and is recognised as an alternative in the management of certain long-term conditions. To achieve beneficial effects on the body, exercise recommendations are based on several parameters such as duration, intensity and continuous or intermittent nature of the activity. However, the mode of muscle contraction during exercise is generally little considered or poorly defined in these recommendations, which can lead to prescribing errors. In particular, the eccentric contraction modality, which can be found in actions designed to slow down movement (e.g. walking downhill), represents an interesting strategy, but its prescription modalities are still poorly understood.
The beneficial effects of physical activity are based in part on the release of molecules (myokines) by the skeletal muscles during exercise, which improve the functioning of the body. However, the effect of downhill walking on the release of myokines by the muscle has been little studied. The lack of knowledge of this effect is therefore an obstacle to the use of this exercise modality to try to optimise physical activity recommendations for health or performance improvement.
The aim of this study is therefore to better understand how downhill walking (eccentric muscle contraction) affects the production of molecules by muscles (myokines) during exercise.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
After being informed of the aims, nature and possible risks of the study, written informed consent will be obtained from the subjects.
Prior to enrolment, volunteers will undergo a medical evaluation that includes a review of personal and family medical history, any current medications, and a standard physical examination. Compliance with the inclusion/exclusion criteria will be checked during this examination.
After enrolment, subjects will perform a treadmill familiarization session.
Experimental days:
- Subjects will complete a 45-minute walking exercise on a negative gradient treadmill (6 km/h) in a randomised 2-way cross-over design with either a -10% or -20% gradient.
- Blood will be sampled immediately pre-exercise, 1-h and 24-h post-exercise for the analysis of muscle myokines.
- Exercise-induced muscle fatigue in lower limbs will be evaluated using squat and counter-movement jumps immediately before and post-exercise.
- Heart-rate variability will be measured during the eccentric exercise session.
- Thigh muscle volume will be measured immediately before and post-exercise.
- Exercise-induced myalgia at 24-, 48-, 72- and 96h will be assessed using a visual analogue scale.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Clermont-Ferrand, Francia
- Chu Clermont Ferrand
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Body Mass Index between 18.5 and 24.9 kg/m² (18.5 ≤ BMI ≤ 24.9)
- Non-smoker
- No treatment (background or at the time of the examination)
- Physical check up considered compatible with study participation (no bones, articular or muscular problems in lower limbs)
- Subjects considered healthy by investigator based on medical questioning and clinical examination
- Affiliation to the French Social Security system
- Person who has read and understood the research-related information, and signed the consent forms
Exclusion Criteria:
- Smoking
- Subjects with heart or respiratory failure
- Participants with lower extremity injury in the past three months
- Contraindication to the application of a magnetic field (wearing a pacemaker, presence of prosthetic material or ferromagnetic foreign bodies, presence of cochlear implants or ocular prosthetic material)
- Participant that does not wish to participate (refusal to sign the consent form)
- Patients under guardianship, trusteeship, deprived of liberty or safeguard of justice
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: downhill treadmill walking -10% gradient
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% incline) |
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% or -20% incline) |
|
Sperimentale: downhill treadmill walking -20% gradient
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-20% incline) |
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% or -20% incline) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Effect of eccentric exercise on myokine concentrations
Lasso di tempo: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
|
Changes in systemic myokine levels following submaximal downhill treadmill exercise at different inclines, at the same speed and for the same duration. |
Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
|
|
Effect of treadmill inclination on myokine concentrations
Lasso di tempo: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
|
Differences in systemic myokine levels concentrations following -10 and -20% gradient submaximal downhill treadmill exercises, at the same speed and for the same duration. |
Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of exercise-induced muscle fatigue in lower limbs
Lasso di tempo: Baseline (prior exercise) and 15 seconds post-exercise
|
squat jump |
Baseline (prior exercise) and 15 seconds post-exercise
|
|
Assessment of exercise-induced muscle fatigue in lower limbs
Lasso di tempo: Baseline (prior exercise) and 15 seconds post-exercise
|
counter-movement jump |
Baseline (prior exercise) and 15 seconds post-exercise
|
|
Assessment of autonomic nervous system function
Lasso di tempo: During treadmill exercise
|
Heart rate variability (HRV) analysis Temporal and spectral analyses of cardiac variability |
During treadmill exercise
|
|
Effect of treadmill exercise on muscle volume
Lasso di tempo: Baseline (prior exercise) and 15 seconds post-exercise
|
Measurement of thigh and calf circumferences |
Baseline (prior exercise) and 15 seconds post-exercise
|
|
Effect of treadmill exercise on muscle pain
Lasso di tempo: Baseline (prior exercise) and 15 seconds post-exercise
|
Measurement of muscle pain induced by a half-squat movement (self-measurement by the subject using a visual analogic scale, 0-10) |
Baseline (prior exercise) and 15 seconds post-exercise
|
|
Effect of treadmill exercise on delayed onset muscle soreness
Lasso di tempo: Baseline (prior exercise) and Hour 24, Hour 48, Hour 72, Hour 96 post-exercise
|
Measurement of muscle pain induced by eccentric exercise (self-measurement by the subject using a visual analogic scale, 0-10) |
Baseline (prior exercise) and Hour 24, Hour 48, Hour 72, Hour 96 post-exercise
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- RBHP 2022 RANNOU
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .