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NCT Number: NCT07278141

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

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:

• 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.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arica- Chile y Valencia -España, Arica, Arica y Parinacota Region, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Anaerobic therapeutic exercises (resistance exercise)

Procedure

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 Task

Combination 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).

Primary outcomes

  1. Physical-functional condition - Risk of falls

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

    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)

  2. Executive function - Inhibitory control

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

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

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

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

    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).

  4. Physical - functional condition - Physical function

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

    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).

  5. Physical - functional condition - Grip Strength

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

    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)

  6. Executive Function - Working Memory

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

    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)

  7. Executive Function - Cognitive Flexibility

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

    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).

Secondary outcomes

  1. Sociodemographic variable - Age

    Time frame: Baseline

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

  2. Sociodemographic variable - Sex

    Time frame: Baseline

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

  3. Sociodemographic variables-Educational Level

    Time frame: Baseline

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

  4. Health indicators- Comorbidities

    Time frame: Baseline

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

  5. Anthropometric variable- Body Mass Index (BMI)

    Time frame: Baseline

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

Study contacts

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

Arnal-Gómez A Anna, PhD

CONTACT

[email protected]

Jorquera-Caceres I Ivonne, MSc

CONTACT

[email protected]

+56981390837

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas, Chile

Other

Collaborators

  • University of Valencia

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Dec 11, 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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