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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Physical-functional condition - Risk of falls
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 60 years or older
- •Score between 10 and 25 points on the Montreal Cognitive Assessment (MoCA) scale
- •Provide informed consent
排除标准
- •Visual or auditory disability that impedes communication
- •Previous diagnosis of dementia
- •Wheelchair use
- •Progressive or terminal illness
- •Depression
- •History of alcoholism
- •Musculoskeletal or cardiovascular contraindications for strength exercises
- •Color blindness
- •Severe mental or cognitive problems supported by medical reports
结局指标
主要结局
Physical-functional condition - Risk of falls
时间窗: 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)
Executive function - Inhibitory control
时间窗: 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)
Physical - functional condition - Physical function
时间窗: 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
时间窗: 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
时间窗: 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)
Executive Function - Cognitive Flexibility
时间窗: 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).
Oculomotor Function- Saccadic and anti-saccadic oculomotor movement
时间窗: 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).
次要结局
- Anthropometric variable- Body Mass Index (BMI)(Baseline)
- Sociodemographic variable - Age(Baseline)
- Sociodemographic variable - Sex(Baseline)
- Sociodemographic variables-Educational Level(Baseline)
- Health indicators- Comorbidities(Baseline)
研究者
Ivonne Andrea Jorquera Cáceres
Physical therapist, MSc
Universidad Santo Tomas, Chile