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

U

Universidad Santo Tomas, Chile

Status

Not yet enrolling

Conditions

Executive Function (Cognition)
Physical Function
Saccadic Eye Movements

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07278141
4126162

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 3 patient groups

Intervention Group EGR (Experimental group resistance exercises)
Experimental group
Description:
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.
Treatment:
Procedure: Anaerobic therapeutic exercises (resistance exercise)
The EGRD group (Experimental group: resistance exercise plus dual tasks)
Experimental group
Description:
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.
Treatment:
Combination Product: Anaerobic therapeutic exercises (resistance exercise) plus Dual Task
The CG Group (control group)
No Intervention group
Description:
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.

Trial contacts and locations

2

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Central trial contact

Arnal-Gómez A Anna, PhD; Jorquera-Caceres I Ivonne, MSc

Data sourced from clinicaltrials.gov

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