Executive Function (Cognition), Physical Function, Saccadic Eye Movements
Conditions
Keywords
combination training, Dual-Task, Physical-Cognitive Training, aging, older adult, Timed Up & Go, executive function, Resistance Training
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.
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.
Interventions
PROCEDUREAnaerobic 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.
COMBINATION_PRODUCTAnaerobic 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).
Sponsors
University of Valencia
Universidad Santo Tomas, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Executive Function - Cognitive Flexibility | 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). |
| Executive function - Inhibitory control | 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) |
| Oculomotor Function- Saccadic and anti-saccadic oculomotor movement | 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). |
| Physical - functional condition - Physical function | 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). |
| Physical - functional condition - Grip Strength | 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) |
| Executive Function - Working Memory | 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) |
| Physical-functional condition - Risk of falls | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic variable - Sex | Baseline | Sex of participants recorded during the first meeting. Unit of Measure: Male/Female (categorical variable). |
| Sociodemographic variables-Educational Level | Baseline | Highest educational level attained by participants. Unit of Measure: Categorical variable (e.g., primary, secondary, higher education). |
| Health indicators- Comorbidities | Baseline | Presence of comorbidities such as hypertension, diabetes, or hypercholesterolemia, collected through validated questionnaires. Unit of Measure: Presence/absence (binary categorical variable). |
| Anthropometric variable- Body Mass Index (BMI) | Baseline | BMI calculated according to WHO protocols as weight (kg) divided by height squared (m²). Unit of Measure: kg/m² |
| Sociodemographic variable - Age | Baseline | Age of participants recorded during the first meeting. Unit of Measure: Years |
Countries
Chile, Spain
Contacts
Primary ContactJorquera-Caceres I Ivonne, MSc
Backup ContactArnal-Gómez A Anna, PhD
Outcome results
None listed