NCT04886115

Brief Summary

The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations. A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3.3 years

First QC Date

May 10, 2021

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum isometric force developed in the quadriceps

    6 weeks of training

Study Arms (3)

Eccentric pedalling group at 15 rpm

EXPERIMENTAL
Other: Neuromuscular evaluationOther: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling taskOther: Pedaling at 15 rpm

Eccentric pedalling group at 60 rpm

EXPERIMENTAL
Other: Neuromuscular evaluationOther: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling taskOther: Pedaling at 60rpm

Control

ACTIVE COMPARATOR
Other: Neuromuscular evaluationOther: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling taskOther: No pedaling, usual activity

Interventions

Before and after training. Muscle function: * voluntary maximal isometric force of the knee extensors * evoked force in the knee extensors by double percutaneous electrical stimulation at 100 and 10 Hz * level of voluntary activation * voluntary maximum force in concentric and eccentric mode at an angular speed of 60°.s-1 * squat jump and counter-movement jump

ControlEccentric pedalling group at 15 rpmEccentric pedalling group at 60 rpm

Before and after training. Cardiovascular-respiratory function: * Oxygen consumption during the incremental concentric pedaling test conducted to high effort perception. * heart rate during pedaling tasks Muscle architecture: \- Pennation angle and thickness of vastus lateralis, rectus femoris, gastrocnemius medialis and lateralis muscles, before and after training. Familiarization with eccentric pedaling

ControlEccentric pedalling group at 15 rpmEccentric pedalling group at 60 rpm

3 training sessions per week for 6 weeks

Eccentric pedalling group at 15 rpm

Maintain usual physical activity and diet for a period of 6 weeks.

Control

3 sessions per week of training for 6 weeks

Eccentric pedalling group at 60 rpm

Eligibility Criteria

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

You may qualify if:

  • Person who has given oral consent
  • Subject capable of understanding simple commands and giving consent
  • Subject (male or female) between 18 and 40 years of age.
  • Subject able to do moderate physical activity

You may not qualify if:

  • Person not affiliated to national health insurance.
  • Physical disabilities affecting the lower limbs or the pelvis, and which may hinder or prevent the practice of exercise on an ergocycle, whether neurological (central or peripheral), arterial (in particular, arterial disease of the lower limbs with a systolic index \< 0.6) or orthopedic (degenerative or inflammatory rheumatism).
  • Person under legal protection (curatorship, guardianship)
  • Person under court order (sauvegarde de justice)
  • Pregnant, parturient or breastfeeding women
  • Major unable to express consent
  • Minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 13, 2021

Study Start

February 7, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations