NCT06193824

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

May 4, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 11, 2024

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

June 23, 2023

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Assessment of exercise-induced muscle fatigue in lower limbs

    Baseline (prior exercise) and 15 seconds post-exercise

  • Assessment of exercise-induced muscle fatigue in lower limbs

    Baseline (prior exercise) and 15 seconds post-exercise

  • Assessment of autonomic nervous system function

    During treadmill exercise

  • Effect of treadmill exercise on muscle volume

    Baseline (prior exercise) and 15 seconds post-exercise

  • Effect of treadmill exercise on muscle pain

    Baseline (prior exercise) and 15 seconds post-exercise

  • +1 more secondary outcomes

Study Arms (2)

downhill treadmill walking -10% gradient

EXPERIMENTAL

The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% incline)

Device: Experimental: downhill treadmill walking at -10% and -20% gradient

downhill treadmill walking -20% gradient

EXPERIMENTAL

The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-20% incline)

Device: Experimental: downhill treadmill walking at -10% and -20% gradient

Interventions

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

downhill treadmill walking -10% gradientdownhill treadmill walking -20% gradient

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

January 5, 2024

Study Start

May 4, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 11, 2024

Record last verified: 2023-05

Locations