Optimisation of Eccentric Exercises

Healthy Control Subjects Clinical Trial

— OPTIMEX  

Official title:

Characterization of the Endocrine Response to Exercise: Impact of the Muscle Contraction Modality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193824
• Other study ID #: RBHP 2022 RANNOU
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Control Subjects

Intervention

Device:
• Experimental: downhill treadmill walking at -10% and -20% gradient
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% or -20% incline)

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of eccentric exercise on myokine concentrations	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
Primary	Effect of treadmill inclination on myokine concentrations	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
Secondary	Assessment of exercise-induced muscle fatigue in lower limbs	squat jump	Baseline (prior exercise) and 15 seconds post-exercise
Secondary	Assessment of exercise-induced muscle fatigue in lower limbs	counter-movement jump	Baseline (prior exercise) and 15 seconds post-exercise
Secondary	Assessment of autonomic nervous system function	Heart rate variability (HRV) analysis Temporal and spectral analyses of cardiac variability	During treadmill exercise
Secondary	Effect of treadmill exercise on muscle volume	Measurement of thigh and calf circumferences	Baseline (prior exercise) and 15 seconds post-exercise
Secondary	Effect of treadmill exercise on muscle pain	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
Secondary	Effect of treadmill exercise on delayed onset muscle soreness	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