NCT06532786

Brief Summary

The aim of the study is to investigate the effects of incorporating variability within Resistance Training (RT) methods on the neural adaptations along the corticospinal tract and on neuromuscular function. The literature suggests that RTis one of the most common modalities to enhance and restore muscle function and its practice results in adaptation in neural and morphological adaptations. It is also known that conditions such as ageing and injury have a negative impact on neural drive to the muscles with consequences at motor control level that are not addressed by traditional RT. Recent approaches such as metronome paced strength training have been used to cover this motor control dimension through a greater control and consciousness of movement. However, this methodology tends not to incorporate the inherent variability and complex, fractal-like fluctuations that characterize human movement. The investigators propose that incorporating variability through a fractal-like metronome approach will speed up the neural adaptations which will be useful in injury rehab.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
8mo left

Started Sep 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

July 29, 2024

Last Update Submit

January 14, 2026

Conditions

Keywords

Motor ControlNeuroscienceNeural AdapatationsTranscranial Magnetic StimulationDynamic SystemsMetronome Paced Strength Training

Outcome Measures

Primary Outcomes (7)

  • Corticospinal Excitability (CSE) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    CSE is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of excitability of the corticospinal tract.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Short-interval Intracortical Inhibition (SICI) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    SICI is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of inhibition within the motor cortex.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Corticospinal Silent Period (CSP) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    CSP is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of inhibition along the corticospinal tract.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Intracortical Facilitation (ICF) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    ICF is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of facilitation within the motor cortex.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Lumbar Evoked Potentials (LEP) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    LEP is a measure extracted through the aplication of Lumbar stimulation. This measure allow to distinguish the adaptations that occur at spinal level as a result of strength training.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Maximal Compound Action Potentials (Mmax) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    Mmax is a measure assessed through peripheral nerve stimulation and represents the maximal capacity of recruit the motoneurons that innerve a muscle.

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • StartReact Gain changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    StartReact gain is a measure that is calculated following the StartReact protocol. It consists in measuring the participants' reaction times in response to visual stimuli (visual reaction time \[VRT\]), visual stimuli combined with a quiet sound (visual auditory reaction time \[VART\]) and visual startling stimuli (visual startling reaction time \[VSRT\]) and, then, apply the following formula: StartReact gain = (\[VRT - VSRT\]/\[VRT - VART\]).

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

Secondary Outcomes (6)

  • Single leg extension 1RM changes after 4-weeks intervention (PRE to POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    PRE (baseline), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Maximal Voluntary Isometric Contraction (MVIC) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Sample Entropy (SampEn) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Coefficient ov variation (CV) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • Motor Unit Action Potentials (MUAP) changes across the 4-weeks intervention (PRE to Week1, Week 2, Week 3, POST and follow-up) both within and between Fractal paced, Isochronus Paced and Self paced groups

    PRE (baseline), W1 (week 1), W2 (week 2), W3 (week 3), POST (week 4), FUP (follow-up 4 weeks after the end of intervention)

  • +1 more secondary outcomes

Study Arms (3)

Fractal Paced

EXPERIMENTAL

Strength training in single leg extension machine, synchronizing each repetition with a fractal-like visual metronome, i.e., a metronome presenting visual external cues with variability within its temporal structure.

Other: Fractal Paced

Isochronous Paced

EXPERIMENTAL

Strength training in single leg extension machine, synchronizing each repetition with a isochronus visual metronome, i.e., a metronome presenting visual external cues withthe same pace in each repetition (without variability)

Other: Isochronous Paced

Self Paced

EXPERIMENTAL

Strength training in single leg extension machine at participants self pace.

Other: Self Paced

Interventions

The intervention consists in a metronome-paced strength training session performed 3 times per week (with 48h of rest between sessions), during 4 weeks. Each session consists in 4 sets of 15 repetitions at 65% of the one-repetition maximal (1RM) in single leg extension machine, synchronizing each repetition with fractal external cues presented by a visual metronome. The rest between sets will be set at 2 minutes of rest between sets.

Fractal Paced

The intervention consists in a metronome-paced strength training session performed 3 times per week (with 48h of rest between sessions), during 4 weeks. Each session consists in 4 sets of 15 repetitions at 65% of the one-repetition maximal (1RM) single in leg extension machine, synchronizing each repetition with isochronus external cues presented by a visual metronome. The rest between sets will be set at 2 minutes of rest between sets.

Isochronous Paced

The intervention consists in a metronome-paced strength training session performed 3 times per week (with 48h of rest between sessions), during 4 weeks. Each session consists in 4 sets of 15 repetitions at 65% of the one-repetition maximal (1RM) in single leg extension machine, at their own self pace (with no metronome). The rest between sets will be set at 2 minutes of rest between sets.

Self Paced

Eligibility Criteria

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

You may qualify if:

  • aged between 18 and 40 years

You may not qualify if:

  • Neurologic conditions;
  • Lower limb disabilities or disease;
  • Not able to provide informed consent;
  • Have an implanted device (e.g. pacemakers) or any metal in the body;
  • Medication advised against the application of Transcranial Magnetic Stimulation;
  • History/family history of seizures, brain lesions or head trauma, neurological or psychiatric diseases, epilepsy, migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz School of Health & Science

Almada, Monte de Caparica, 2829-699, Portugal

RECRUITING

Central Study Contacts

João H Oliveira, MSc

CONTACT

João R Vaz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

September 15, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations