- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278141
Effects of Resistance and Dual-Task Training on Physical, Oculomotor, and Executive Functions in Older Adults With MCI
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:
• 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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jorquera-Caceres I Ivonne, MSc
- Phone Number: +56981390837
- Email: ivonnejorquera@santotomas.cl
Study Contact Backup
- Name: Arnal-Gomez A Anna, PhD
- Email: anna.arnal@uv.es
Study Locations
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Arica y Parinacota Region
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Arica, Arica y Parinacota Region, Chile, 1000000
- Arica- Chile y Valencia -España
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Contact:
- Jorquera-Caceres I Ivonne, MSc
- Phone Number: +56981390837
- Email: ivonnejorquera@santotomas.cl
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Contact:
- Arnal-Gomez A Anna, PhD
- Email: anna.arnal@uv.es
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Principal Investigator:
- Jorquera-Caceres I Ivonne, MSc
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Sub-Investigator:
- Arnal G Anna, PhD
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Sub-Investigator:
- Espií L Gemma, PhD
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Valencia
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Valencia, Valencia, Spain, 46001
- Valencia-Spain
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Contact:
- Arnal-Gomez A Anna, PhD
- Email: anna.arnal@uv.es
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Contact:
- Espì L Gemma, PhD
- Email: gemma.espi@uv.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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Experimental: 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.
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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).
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical-functional condition - Risk of falls
Time Frame: Baseline, and immediately post-intervention (week 11),
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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),
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Executive function - Inhibitory control
Time Frame: Baseline, and immediately post-intervention (week 11-12)
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Participants' inhibitory control will be assessed using the Stroop Colour Test.
Performance will be evaluated through response time.
Unit of Measure: Milliseconds (ms)
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Baseline, and immediately post-intervention (week 11-12)
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Oculomotor Function- Saccadic and anti-saccadic oculomotor movement
Time Frame: Baseline, and immediately post-intervention (week 11)
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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).
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Baseline, and immediately post-intervention (week 11)
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Physical - functional condition - Physical function
Time Frame: Baseline, and immediately post-intervention (week 11)
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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)
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Physical - functional condition - Grip Strength
Time Frame: Baseline, and immediately post-intervention (week 11)
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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)
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Baseline, and immediately post-intervention (week 11)
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Executive Function - Working Memory
Time Frame: Baseline, and immediately post-intervention (week 11-12)
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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)
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Baseline, and immediately post-intervention (week 11-12)
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Executive Function - Cognitive Flexibility
Time Frame: Baseline, and immediately post-intervention (week 11-12)
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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).
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Baseline, and immediately post-intervention (week 11-12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic variable - Age
Time Frame: Baseline
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Age of participants recorded during the first meeting.
Unit of Measure: Years
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Baseline
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Sociodemographic variable - Sex
Time Frame: Baseline
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Sex of participants recorded during the first meeting.
Unit of Measure: Male/Female (categorical variable).
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Baseline
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Sociodemographic variables-Educational Level
Time Frame: Baseline
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Highest educational level attained by participants.
Unit of Measure: Categorical variable (e.g., primary, secondary, higher education).
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Baseline
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Health indicators- Comorbidities
Time Frame: Baseline
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Presence of comorbidities such as hypertension, diabetes, or hypercholesterolemia, collected through validated questionnaires.
Unit of Measure: Presence/absence (binary categorical variable).
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Baseline
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Anthropometric variable- Body Mass Index (BMI)
Time Frame: Baseline
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BMI calculated according to WHO protocols as weight (kg) divided by height squared (m²).
Unit of Measure: kg/m²
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jorquera-Caceres I Ivonne, MSc, Universidad Santo Tomas, Chile
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4126162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study Protocol
Information identifier: Study Protocol ACTIVAMInformation comments: The study protocol is accessible to anyone with the link
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Data Monitoring Committee Charter
Information identifier: Ethics Committee ApprovalInformation comments: The file is publicly available via link
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Informed Consent Form
Information identifier: INFORMED CONSENT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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