Healthy AgingNCT06538766
The Effect of Different Focus of Attention Instructions on Resistance Training and Its Transfer to Gait Parameters in Older Adults
A study testing Strength training with an internal focus of attention, Strength training with a proprioceptive external focus of attention and Strength training with a visual external focus of attention in people with Healthy Aging and Healthy, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy
- What is being tested?
- Strength training with an internal focus of attention, Strength training with a proprioceptive external focus of attention and Strength training with a visual external focus of attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
Who cannot join
- Severe cardiovascular or pulmonary disease
- Oncological disease
- Lower limb disabilities
- Neurological disorders
- Inability to walk unassisted for 12 continuous minutes
- Cognitive impairment
Show all 10Show fewer
- Falls in the prior 12 months
- Orthopedic concerns, which might limit force production
- Metal implants
- Medicine that can trigger side effects with TMS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Egas Moniz School of Health & Science
Monte de Caparica, Almada, 2829 - 511
Inês Gomes, egasmoniz@egasmoniz.edu.pt
About this study
Official title: Strength Training for Gait Rehabilitation in Older Adults: Insights From Neuroscience
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?
Read more
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.
- Conditions
- Healthy Aging, Healthy
- Being tested
- Strength training with an internal focus of attention, Strength training with a proprioceptive external focus of attention, Strength training with a visual external focus of attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training with an internal focus of attentionOther
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 attentionOther
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 attentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Internal Focus Condition | Active comparator | In the internal focus condition the participant is instructed to realize seated calf raises by focusing on contracting the plantar-flexors. In clinical applications the internal focus is the most commonly used instruction. It is not possible to have a neutral focus condition, as participants always have to receive instructions and will always be focusing on something. Therefore, the internal focus condition is used as an active comparator. Receives: Other: Strength training with an internal focus of attention |
| Proprioceptive External Focus Condition | Experimental | In the proprioceptive external focus condition the participant is instructed to realize seated calf raises by focusing on lifting the machine's bar. Receives: Other: Strength training with a proprioceptive external focus of attention |
| Visual External Focus Condition | Experimental | In the visual external focus condition the participant is instructed to realize seated calf raises by focusing on a line representing the displacement of the bar projected on a screen. Receives: Other: Strength training with a visual external focus of attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Non-linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Cortico-Spinal Excitability after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Cortico-Spinal Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Intra-Cortical Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Intra-Cortical Facilitation after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Secondary outcomes (5)
Change from Baseline in Antagonist Co-Contraction Index after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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).
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up
The linear measure of variability is analyzed with the coefficient of variation (CV), which indicates the amount of variability within the force signal.
Measured: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up
The linear measure of variability is analyzed with the coefficient of variation (CV), which indicates the amount of variability within the gait signal.
Measured: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline of Hip, Knee, Ankle Range of Motion during Gait after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline of Minimum Toe Clearance during Gait after after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
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.
Measured: Baseline, Week2, Week4 and Follow-Up (Week6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538766
- Sponsor's protocol ID
- 1236- Fractal of attention
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bauer P, Oliveira JH, Gomes JS, Marques T, Tallent J, Cortes N, Vaz JR. Visual external focus of attention modulates corticospinal excitation-inhibition balance after acute exercise. Eur J Appl Physiol. 2026 Oct 31. doi: 10.1007/s00421-026-06487-0. Online ahead of print.
PubMed 42965622
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training for Gait Rehabilitation in Older Adults: Insights From Neuroscience
- ClinicalTrials.gov ID
- NCT06538766
- Acronym / sponsor ID
- 1236- Fractal of attention
- Conditions
- Healthy Aging, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal Focus Condition | Active comparator | Other: Strength training with an internal focus of attentionIn the internal focus condition the participant is instructed to realize seated calf raises by focusing on contracting the plantar-flexors. In clinical applications the internal focus is the most commonly used instruction. It is not possible to have a neutral focus condition, as participants always have to receive instructions and will always be focusing on something. Therefore, the internal focus condition is used as an active comparator. |
| Proprioceptive External Focus Condition | Experimental | Other: Strength training with a proprioceptive external focus of attentionIn the proprioceptive external focus condition the participant is instructed to realize seated calf raises by focusing on lifting the machine's bar. |
| Visual External Focus Condition | Experimental | Other: Strength training with a visual external focus of attentionIn the visual external focus condition the participant is instructed to realize seated calf raises by focusing on a line representing the displacement of the bar projected on a screen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (10 listed)
- Severe cardiovascular or pulmonary disease
- Oncological disease
- Lower limb disabilities
- Neurological disorders
- Inability to walk unassisted for 12 continuous minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training with an internal focus of attentionA 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. | Other | Internal Focus Condition |
| Strength training with a proprioceptive external focus of attentionA 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. | Other | Proprioceptive External Focus Condition |
| Strength training with a visual external focus of attentionA 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. | Other | Visual External Focus Condition |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 42965622Bauer P, Oliveira JH, Gomes JS, Marques T, Tallent J, Cortes N, Vaz JR. Visual external focus of attention modulates corticospinal excitation-inhibition balance after acute exercise. Eur J Appl Physiol. 2026 Oct 31. doi: 10.1007/s00421-026-06487-0. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training with an internal focus of attention, Strength training with a proprioceptive external focus of attention and Strength training with a visual external focus of attention in people with Healthy Aging and Healthy, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Bauer, MSc (1722831739 ext. +49, 117473@alunos.egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.