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NCT Number: NCT06538766

The Effect of Different Focus of Attention Instructions on Resistance Training and Its Transfer to Gait Parameters in Older Adults

The goal of this clinical trial is to investigate the effects of strength training with different focus of attention strategies on plantar flexor force and how this affects gait in apparently healthy older adults. The main questions it aims to answer are:

* Is there an acute effect of focus of attention on non-linear force variability and the subjacent neurophysiological mechanisms in apparently healthy young and older adults? * Is there a training effect of focus of attention on non-linear force variability and does it transfer to non-linear gait variability as well as the respective subjacent neurophysiological mechanisms in apparently healthy older adults?

Researchers will compare two different external focus strategies with an internal focus to see if non-linear variability increases and subjacent neurophysiological mechanisms are more automized with an external focus of attention compared to an internal focus. In the acute study young adults are assessed as the differences between focus conditions are thought to be in the same direction as for older adults but attenuated.

Participants will carry out training and strength assessments of the calf muscles and walking on a treadmill.

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Key information

Conditions

Healthy Aging Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egas Moniz School of Health & Science

Monte de Caparica, Almada, 2829 - 511, Portugal

Location status: Recruiting

Location contact

Inês Gomes

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent

Exclusion criteria

  • Severe cardiovascular or pulmonary disease
  • Oncological disease
  • Lower limb disabilities
  • Neurological disorders
  • Inability to walk unassisted for 12 continuous minutes
  • Cognitive impairment
  • Falls in the prior 12 months
  • Orthopedic concerns, which might limit force production
  • Metal implants
  • Medicine that can trigger side effects with TMS

Treatment and study plan

Strength training with an internal focus of attention

Other

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific internal focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Strength training with a proprioceptive external focus of attention

Other

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific proprioceptive external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Strength training with a visual external focus of attention

Other

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific visual external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Primary outcomes

  1. Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

    The non-linear variability of the temporal structure of the force signal of a 50 seconds isometric task at 50% of the maximum voluntary isometric contraction is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular force output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable force output.

  2. Change from Baseline in Non-linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

    The non-linear variability of the temporal structure of the gait signal from a 12 minutes gait trial is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular gait output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable gait output.

  3. Change from Baseline in Cortico-Spinal Excitability after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal excitability single-pulse TMS is applied. For cortico-spinal excitability the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the EMG maximum voluntary contraction.

  4. Change from Baseline in Cortico-Spinal Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal inhibition single-pulse TMS is applied. For cortico-spinal inhibition the mean of electromyographic silent periods from 10 stimulations is calculated. The values are presented in ms.

  5. Change from Baseline in Intra-Cortical Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical inhibition paired-pulse TMS is applied. For intra-cortical inhibition the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

  6. Change from Baseline in Intra-Cortical Facilitation after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical facilitation paired-pulse TMS is applied. For intra-cortical facilitation the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

Secondary outcomes

  1. Change from Baseline in Antagonist Co-Contraction Index after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    The antagonist co-contraction index (CCI) of the soleus as well as of the lateral and medial gastrocnemius heads with tibialis anterior will be calculated based on the formula: CCI=lowEMG/highEMG×(highEMG+lowEMG).

  2. Change from Baseline in Linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

    The linear measure of variability is analyzed with the coefficient of variation (CV), which indicates the amount of variability within the force signal.

  3. Change from Baseline in Linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

    The linear measure of variability is analyzed with the coefficient of variation (CV), which indicates the amount of variability within the gait signal.

  4. Change from Baseline of Hip, Knee, Ankle Range of Motion during Gait after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    Hip, knee, ankle range of motion during gait will be assessed using a motion capture system. This analysis assesses the angular displacement of each joint through the different phases of the gait cycle. For the hip and knee joint the ROM involves flexion and extension, while for the ankle joint dorsiflexion and plantarflexion are measured.

  5. Change from Baseline of Minimum Toe Clearance during Gait after after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Time frame: Baseline, Week2, Week4 and Follow-Up (Week6)

    Minimum toe clearance during gait will be assessed using a motion capture system. This analysis measures the smallest vertical distance between the toe and the ground during the swing phase of the gait cycle.

Study contacts

Contact information is provided by the study sponsor or research team.

Joao Vaz, PhD

CONTACT

[email protected]

967096444 ext. +351

Philipp Bauer, MSc

CONTACT

[email protected]

1722831739 ext. +49

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

Strength Training for Gait Rehabilitation in Older Adults: Insights From Neuroscience

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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