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Physical FunctionNCT07278141

Effects of Resistance and Dual-Task Training on Physical, Oculomotor, and Executive Functions in Older Adults With MCI

A study testing Anaerobic therapeutic exercises (resistance exercise) and Anaerobic therapeutic exercises (resistance exercise) plus Dual Task in people with Physical Function and Executive Function (Cognition), run by Universidad Santo Tomas, Chile at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to determine the effect of a combined therapeutic intervention program with anaerobic exercises (resistance exercises) and dual tasks on the physical, oculomotor, and executive functions of older adults with mild cognitive impairment. Read more about this study

Who is it for?
Ages 60 to 90 years
What is being tested?
Anaerobic therapeutic exercises (resistance exercise) and Anaerobic therapeutic exercises (resistance exercise) plus Dual Task
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesin 2 countries
Study dates
17 Jan 2026to 17 Dec 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 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 60 years or older
  • Score between 10 and 25 points on the Montreal Cognitive Assessment (MoCA) scale
  • Provide informed consent

Who cannot join

  • Visual or auditory disability that impedes communication
  • Previous diagnosis of dementia
  • Wheelchair use
  • Epilepsy
  • Progressive or terminal illness
  • Depression
Show all 11Show fewer
  • History of alcoholism
  • Musculoskeletal or cardiovascular contraindications for strength exercises
  • Color blindness
  • Dyslexia
  • Severe mental or cognitive problems supported by medical reports

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jorquera-Caceres I Ivonne, MSc contact

+56981390837

ivonnejorquera@santotomas.cl

Arnal-Gómez A Anna, PhD contact

anna.arnal@uv.es

2 sites in 2 countries

Chile1 site
  • Arica- Chile y Valencia -España

    Arica, Arica y Parinacota Region, 1000000

    Jorquera-Caceres I Ivonne, MSc, +56981390837, ivonnejorquera@santotomas.cl

    Arnal-Gómez A Anna, PhD, anna.arnal@uv.es

Other trials in Chile

Spain1 site
  • Valencia-Spain

    Valencia, Valencia, 46001

    Arnal-Gomez A Anna, PhD, anna.arnal@uv.es

    Espì L Gemma, PhD, gemma.espi@uv.es

Other trials in Spain

About this study

Official title: Study Protocol: Effects of Combined Resistance Training and Dual-Task Interventions on Physical, Oculomotor, and Executive Functions in Older Adults With Mild Cognitive Impairment. A Randomized Controlled Trial

The goal of this clinical trial is to determine the effect of a combined therapeutic intervention program with anaerobic exercises (resistance exercises) and dual tasks on the physical, oculomotor, and executive functions of older adults with mild cognitive impairment.

The main questions it aims to answer are:

Read more
  • How effective will a therapeutic intervention program combining resistance exercises with dual tasks be in improving the physical, oculomotor, and executive functions of older adults with mild cognitive impairment living in the community? Researchers will compare the effectiveness of a resistance exercise training program combined with dual tasks versus a resistance-only exercise training program to see if it improves the physical, oculomotor, and executive functions of older adults with mild cognitive impairment

Participants Will:

  • Receive resistance exercises, resistance exercises combined with dual tasks. or the standard health care. The intervention programs will consist of 3 weekly sessions over 8 weeks.
  • Before the start and after the completion of the programs, they will be evaluated using a battery of tests. This includes sociodemographic and general health background, physical fitness tests, as well as assessments of executive functions and oculomotor Saccadic movements and anti-saccadic error.
  • be required to sign a consent form.
Read the detailed description

A randomized clinical trial will be conducted with two experimental groups and one control group. The target population will be older adults with mild cognitive impairment living in the communities of Arica (Chile) and Valencia (Spain). All participants must score between 10 and 25 points on the Montreal Cognitive Assessment (MoCA).

The sample size was calculated using statistical software, based on mean differences reported in prior studies on training and dual tasks in older adults. A minimum of 11 participants per group was established, adjusted for a 20% dropout rate, a significance level of 0.01, and a statistical power of 0.9.

In each city, 33 participants (men and women in a 1:1 ratio) will be recruited. Random distribution by gender will assign participants to three groups:

EGR: Resistance exercises only.

EGRD: Resistance exercises combined with dual tasks (cognitive tasks).

CG: Control group, receiving standard health care during the study and, upon completion, the best-evaluated therapeutic intervention.

Procedure The study will last 12 weeks: two weeks for baseline measurements (pre-test), eight weeks for training protocols, and two weeks for final measurements (post-test). Evaluations will include sociodemographic and health data, functional physical condition tests, executive function assessments, and saccadic and anti-saccadic eye movement measures.

Interventions will be conducted at the physiotherapy faculties of the participating universities, supervised by experienced professionals blinded to group allocation. Participants will be asked not to engage in physical exercise outside the study protocols during evaluation weeks.

Hypotheses

Primary: The combined intervention of resistance exercises and dual tasks is more effective than isolated resistance training in improving physical, executive, and oculomotor functions in older adults with mild cognitive impairment.

Secondary: The combined intervention produces greater improvements in executive function tasks (Stroop Test, Corsi Block-Tapping Test, Trail Making Test) compared to resistance training alone.

Intervention Program

The intervention will last eight weeks, with three weekly sessions (20-24 sessions total). Each resistance training session will last one hour, divided into:

Warm-up: Joint mobility and basic movements; Resistance training: Exercises with external load; Cool-down: Breathing exercises and stretching.

Exercises will target flexor and extensor groups of the elbow and knee, including bilateral leg press, unilateral knee extensions, and bilateral elbow flexion/extension. Three sets of eight repetitions will be performed for each muscle group. Training intensity will begin at 60% of one-repetition maximum (1RM) and progress to 80% by week 7, adjusted every two weeks based on new strength evaluations and perceived exertion.

The combined group (EGRD) will follow the same physical protocol, incorporating memory and arithmetic tasks during exercise execution.

Assessment Instruments

Functional physical condition: Timed Up and Go Test (TUG), Short Physical Performance Battery (SPPB), and grip strength measured with a hydraulic dynamometer.

Executive functions: Inhibitory control: Stroop Test, with three conditions (word, color, word-color); Working memory: Corsi Block-Tapping Test (CBTT), assessing visuo-spatial memory sequences; Cognitive flexibility: Trail Making Test (TMT-A and TMT-B), evaluating speed, attention, and alternation.

Oculomotor function: Electrooculography (EOG) will record saccadic and anti-saccadic movements using surface electrodes and controlled visual stimuli.

Statistical Analysis Population data will be presented as means for continuous variables and prevalence for categorical variables, with 95% confidence intervals. Inferential analyses will consider normality and homoscedasticity to determine parametric or non-parametric tests. A blinded researcher will conduct all analyses using IBM SPSS version 27.

Being tested
Anaerobic therapeutic exercises (resistance exercise), Anaerobic therapeutic exercises (resistance exercise) plus Dual Task
Keywords
combination training, Dual-Task, Physical-Cognitive Training, aging, older adult, Timed Up & Go, executive function, Resistance Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anaerobic therapeutic exercises (resistance exercise)Procedure or surgery

    The intervention period will last 8 weeks, with 3 sessions per week. Each resistance training session will last one hour and will consist of three parts: the first part will include joint mobility and basic preparatory movements; the second part will involve the resistance training itself (with added weight); and finally, the third part will feature breathing exercises and stretches as a cool-down. Weighted exercises will focus on the elbow flexor/extensor groups and the knee flexor/extensor groups through bilateral leg presses, unilateral knee extensions, and bilateral elbow flexion-extension exercises, performed in 3 sets of 8 repetitions for each muscle group trained. The training intensity for the first two weeks will be set at 60% of 1RM and will then be increased to the target intensity (80% of 1RM) by at least week 7 of the training. To ensure that the training program is progressive, a 1RM strength evaluation will be performed every two weeks, to adjust the training load.

  • Anaerobic therapeutic exercises (resistance exercise) plus Dual TaskCombination product

    The anaerobic (resistance) exercise training group combined with dual tasks will follow the same protocol as the previously described anaerobic therapeutic exercise training and will additionally incorporate memory and arithmetic tasks concurrently during the exercises. The intervention period will also last 8 weeks, with 3 sessions per week, and each training session will last one hour (Pantoja-Cardoso et al. 2023).

Study groups in NCT07278141
Study groupRoleWhat they receive
Intervention Group EGR (Experimental group resistance exercises)ExperimentalEGR will receive only anaerobic therapeutic exercises (resistance exercises) for 8 weeks, with 3 sessions per week. The exercises will focus on the elbow flexor/extensor groups and the knee flexor/extensor groups, using a bilateral leg press, unilateral knee extensions, and bilateral elbow flexion-extension exercises, performed in 3 sets of 8 repetitions for each trained muscle group.
Receives: Procedure: Anaerobic therapeutic exercises (resistance exercise)
The EGRD group (Experimental group: resistance exercise plus dual tasks)ExperimentalThe EGRD group (experimental group: resistance exercise plus dual tasks) will receive 8 weeks of anaerobic therapeutic exercises (resistance exercises) combined with dual tasks during sessions. They will perform the same exercise protocol as the EGR group and concurrently add memory and arithmetic tasks during the exercises.
Receives: Combination Product: Anaerobic therapeutic exercises (resistance exercise) plus Dual Task
The CG Group (control group)No interventionThe control group (CG) will receive usual health care during the intervention period; however, they will receive the best evaluated therapeutic intervention at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical-functional condition - Risk of falls

    The physical-functional condition, specifically the risk of falls of participants will be assessed using the Timed Up and Go Test (TUG). Description: Time in seconds required to stand up from a chair, walk three meters, turn, return, and sit down. Unit of Measure: Seconds (s)

    Measured: Baseline, and immediately post-intervention (week 11),

  2. Executive function - Inhibitory control

    Participants' inhibitory control will be assessed using the Stroop Colour Test. Performance will be evaluated through response time. Unit of Measure: Milliseconds (ms)

    Measured: Baseline, and immediately post-intervention (week 11-12)

  3. Oculomotor Function- Saccadic and anti-saccadic oculomotor movement

    Saccadic and anti-saccadic eye movements will be assessed using a non-invasive electrooculography (EOG) system (ADInstruments PTK15 EOG model and AD Instruments Brazil PowerLab T26-3079). Two surface electrodes will be placed at the outer canthi of the right and left eyes, with a ground electrode positioned on the forehead. Synchronization between target illumination and EOG signals will be controlled using LabChart software (version 7, Research Ltd.). Performance will be evaluated based on movement latency during visual tasks: left-to-right for saccadic movements and right-to-left for anti-saccadic movements. Unit of Measure: Milliseconds (ms).

    Measured: Baseline, and immediately post-intervention (week 11)

  4. Physical - functional condition - Physical function

    The Physical-functional condition, specifically Participants' physical function will be assessed with the Short Physical Performance Battery (SPPB).

    Description: Composite score evaluating balance, gait speed, and lower limb strength. Unit of Measure: Points on a scale (0-12).

    Measured: Baseline, and immediately post-intervention (week 11)

  5. Physical - functional condition - Grip Strength

    The Physical-functional condition, specifically the grip strenght of particiants will be assesment with the JAMAR dynamometer. Description: Maximum grip strength measured with a hydraulic dynamometer. Unit of Measure: Kilograms (kg)

    Measured: Baseline, and immediately post-intervention (week 11)

  6. Executive Function - Working Memory

    Working memory will be assessed using the Corsi Block-Tapping Test (CBTT), administered in both forward and backward conditions. Performance will be evaluated based on response time for each condition. Unit of Measure: Milliseconds (ms)

    Measured: Baseline, and immediately post-intervention (week 11-12)

  7. Executive Function - Cognitive Flexibility

    Cognitive flexibility will be assessed using the Trail Making Test (TMT). Performance will be evaluated through completion time for Part A (numbers only) and Part B (numbers and letters alternating). Unit of Measure: Miliseconds (ms).

    Measured: Baseline, and immediately post-intervention (week 11-12)

Secondary outcomes (5)
  1. Sociodemographic variable - Age

    Age of participants recorded during the first meeting. Unit of Measure: Years

    Measured: Baseline

  2. Sociodemographic variable - Sex

    Sex of participants recorded during the first meeting. Unit of Measure: Male/Female (categorical variable).

    Measured: Baseline

  3. Sociodemographic variables-Educational Level

    Highest educational level attained by participants. Unit of Measure: Categorical variable (e.g., primary, secondary, higher education).

    Measured: Baseline

  4. Health indicators- Comorbidities

    Presence of comorbidities such as hypertension, diabetes, or hypercholesterolemia, collected through validated questionnaires. Unit of Measure: Presence/absence (binary categorical variable).

    Measured: Baseline

  5. Anthropometric variable- Body Mass Index (BMI)

    BMI calculated according to WHO protocols as weight (kg) divided by height squared (m²). Unit of Measure: kg/m²

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start17 Jan 2026 (estimated)
  3. Primary completion17 Nov 2026 (estimated)
  4. Study completion17 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention period will last 8 weeks, with therapeutic intervention programs consisting of 3 weekly sessions. The older adults (OA) of EGR group will receive a minimum of 20 sessions, with a maximum of up to 24 sessions. Each resistance training session will last one hour and will consist of three parts: Preparation (joint mobility and basic movements for warm-up), Resistance Training (Implementing added weight exercises), Cool Down (breathing exercises and stretches). Weight exercises will focus on the flexor/extensor groups of the elbow and the flexor/extensor groups of the knee, through bilateral leg presses, unilateral knee extensions, and bilateral elbow flexo-extensions. These exercises will be performed in 3 sets of 8 repetitions for each trained muscle group. The combined resistance training group with dual-task exercises (EGRD) will follow the same exercise protocol and additionally incorporate memory and arithmetic tasks. The CG will receive the usual care.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278141
Sponsor's protocol ID
4126162
Status last verified
Nov 2025
First submitted
8 May 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Personal information and data for all experiments are handled by the personal information manager director of Valencia University. Access to information requires a key that is securely kept and has limited access. These internal checks and balances ensure the security of all data and personal information. After the experimental period ends, the data will be consolidated. Any information linking data backto the participant will be discarded to ensure that the data are truly anonymous.

Publications

  • Voos MC, Custodio EB, Malaquias J Jr. Relationship of executive function and educational status with functional balance in older adults. J Geriatr Phys Ther. 2011 Jan-Mar;34(1):11-8. doi: 10.1097/JPT.0b013e3181ff2452.

    PubMed 21937887
  • Vandierendonck A. Working memory benchmarks-A missed opportunity: Comment on Oberauer et al. (2018). Psychol Bull. 2018 Sep;144(9):963-971. doi: 10.1037/bul0000159.

    PubMed 30148381
  • Heath M, Weiler J, Gregory MA, Gill DP, Petrella RJ. A Six-Month Cognitive-Motor and Aerobic Exercise Program Improves Executive Function in Persons with an Objective Cognitive Impairment: A Pilot Investigation Using the Antisaccade Task. J Alzheimers Dis. 2016 Oct 4;54(3):923-931. doi: 10.3233/JAD-160288.

    PubMed 27567829
  • Glisky EL, Alexander GE, Hou M, Kawa K, Woolverton CB, Zigman EK, Nguyen LA, Haws K, Figueredo AJ, Ryan L. Differences between young and older adults in unity and diversity of executive functions. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2021 Nov;28(6):829-854. doi: 10.1080/13825585.2020.1830936. Epub 2020 Oct 8.

    PubMed 33028159

Questions about this trial

What is this clinical trial studying?

A study testing Anaerobic therapeutic exercises (resistance exercise) and Anaerobic therapeutic exercises (resistance exercise) plus Dual Task in people with Physical Function and Executive Function (Cognition), run by Universidad Santo Tomas, Chile at 2 sites in 2 countries.

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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile, Spain. 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 Jorquera-Caceres I Ivonne, MSc (+56981390837, ivonnejorquera@santotomas.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical-functional condition - Risk of falls (time frame: Baseline, and immediately post-intervention (week 11),). The study lists 7 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 NCT07278141, which also lists 4 linked publications.

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 11 Dec 2025.

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