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

NCT ID: NCT07278141

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-17

Study Completion Date

2026-12-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physical Function Executive Function (Cognition) Saccadic Eye Movements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the study design, proper blinding is not feasible, as it is a non-pharmacological within-subject design. The intervention is visible to both the participants and the investigators administering it. To mitigate this issue, in accordance with the CONSORT extension for non-pharmacological trials (Boutron et al., 2017), the study's hypothesis is concealed from the participants, and the outcomes assessor at the beginning and the end of the intervention will be blinded to the participants' intervention group.

Study Groups

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Intervention Group EGR (Experimental group resistance exercises)

EGR 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.

Group Type EXPERIMENTAL

Anaerobic therapeutic exercises (resistance exercise)

Intervention Type 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.

The EGRD group (Experimental group: resistance exercise plus dual tasks)

The 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.

Group Type EXPERIMENTAL

Anaerobic therapeutic exercises (resistance exercise) plus Dual Task

Intervention Type 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).

The CG Group (control group)

The 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anaerobic therapeutic exercises (resistance exercise)

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.

Intervention Type PROCEDURE

Anaerobic therapeutic exercises (resistance exercise) plus Dual Task

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).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role collaborator

Universidad Santo Tomas, Chile

OTHER

Sponsor Role lead

Responsible Party

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Ivonne Andrea Jorquera Cáceres

Physical therapist, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorquera-Caceres I Ivonne, MSc

Role: STUDY_DIRECTOR

Universidad Santo Tomas, Chile

Locations

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Arica- Chile y Valencia -España

Arica, Arica y Parinacota Region, Chile

Site Status

Valencia-Spain

Valencia, Valencia, Spain

Site Status

Countries

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Chile Spain

Central Contacts

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Jorquera-Caceres I Ivonne, MSc

Role: CONTACT

+56981390837

Arnal-Gómez A Anna, PhD

Role: CONTACT

Facility Contacts

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Jorquera-Caceres I Ivonne, MSc

Role: primary

+56981390837

Arnal-Gómez A Anna, PhD

Role: backup

Arnal-Gomez A Anna, PhD

Role: primary

Espì L Gemma, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21937887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30148381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27567829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33028159 (View on PubMed)

Study Documents

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Document Type: Study Protocol

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View Document

Document Type: Data Monitoring Committee Charter

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View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.bmj.com/lookup/doi/10.1136/bmj-2024-081124

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Other Identifiers

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4126162

Identifier Type: -

Identifier Source: org_study_id

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