NCT07278141

Brief 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. 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

May 8, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2026

Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

May 8, 2025

Last Update Submit

November 28, 2025

Conditions

Keywords

combination trainingDual-TaskPhysical-Cognitive Trainingagingolder adultTimed Up & Goexecutive functionResistance Training

Outcome Measures

Primary Outcomes (7)

  • 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)

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

  • 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)

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

  • 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).

    Baseline, and immediately post-intervention (week 11)

  • 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).

    Baseline, and immediately post-intervention (week 11)

  • 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)

    Baseline, and immediately post-intervention (week 11)

  • 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)

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

  • 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).

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

Secondary Outcomes (5)

  • Sociodemographic variable - Age

    Baseline

  • Sociodemographic variable - Sex

    Baseline

  • Sociodemographic variables-Educational Level

    Baseline

  • Health indicators- Comorbidities

    Baseline

  • Anthropometric variable- Body Mass Index (BMI)

    Baseline

Study Arms (3)

Intervention Group EGR (Experimental group resistance exercises)

EXPERIMENTAL

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.

Procedure: Anaerobic therapeutic exercises (resistance exercise)

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

EXPERIMENTAL

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.

Combination Product: Anaerobic therapeutic exercises (resistance exercise) plus Dual Task

The CG Group (control group)

NO INTERVENTION

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.

Interventions

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 Group EGR (Experimental group resistance exercises)

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

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arica- Chile y Valencia -España

Arica, Arica y Parinacota Region, 1000000, Chile

Location

Valencia-Spain

Valencia, Valencia, 46001, Spain

Location

Related Publications (4)

  • 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.

    PMID: 21937887BACKGROUND
  • 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.

    PMID: 30148381BACKGROUND
  • 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.

    PMID: 27567829BACKGROUND
  • 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.

    PMID: 33028159BACKGROUND

Related Links

Study Officials

  • Jorquera-Caceres I Ivonne, MSc

    Universidad Santo Tomas, Chile

    STUDY DIRECTOR

Central Study Contacts

Jorquera-Caceres I Ivonne, MSc

CONTACT

Arnal-Gómez A Anna, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist, MSc

Study Record Dates

First Submitted

May 8, 2025

First Posted

December 11, 2025

Study Start

January 17, 2026

Primary Completion (Estimated)

November 17, 2026

Study Completion (Estimated)

December 17, 2026

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

Study Protocol (Study Protocol ACTIVAM)Access
Data Monitoring Committee Charter (Ethics Committee Approval)Access
Informed Consent Form (INFORMED CONSENT)Access

Locations