The Effects of Cognitive Task-Based Walking Exercise on Cognitive Function, Depression, Sleep Quality, and Quality of Life in Older Adults With Brain Fog: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
This randomized controlled trial aims to investigate the effects of cognitive task-based walking exercise on cognitive function, depressive symptoms, sleep quality, and quality of life in older adults experiencing brain fog. Eligible participants will be randomly assigned to either a cognitive task-based walking exercise group or a walking-only exercise group. The intervention will be conducted under physiotherapist supervision, three times per week for four weeks. Outcome measures will be assessed at baseline and after the intervention period to compare the effectiveness of the two exercise approaches.
详细描述
This study is a single-center, prospective, randomized controlled trial designed to evaluate the effects of cognitive task-based walking exercise on cognitive function, depression, sleep quality, and quality of life in older adults experiencing brain fog. The study will be conducted between November 2025 and May 2026 at the Geriatrics Outpatient Clinic of Istanbul Medipol Mega Hospital.
Participants aged 65 years and older who report a subjective decline in attention, concentration, or mental clarity for at least four weeks and who demonstrate moderate or greater brain fog symptoms according to the Turkish version of the Brain Fog Scale will be eligible for inclusion. Only individuals with preserved global cognitive function (Montreal Cognitive Assessment score ≥20) and the ability to walk independently, with or without an assistive device, will be enrolled. Individuals with diagnosed neurological disorders, severe psychiatric conditions, or medical problems that limit physical activity will be excluded.
Eligible participants will be randomly assigned, using a computer-generated randomization sequence, to one of two groups: (1) a cognitive task-based walking exercise group or (2) a walking-only exercise group. Both groups will participate in supervised, low-intensity walking exercise sessions three times per week for four weeks. Exercise intensity and progression will be individualized according to each participant's physical capacity and balance status.
Each exercise session will include a warm-up phase, a main walking phase, and a cool-down phase. Participants in the cognitive task-based walking exercise group will be required to perform concurrent cognitive tasks during walking, including forward and backward counting, verbal fluency tasks, and sequencing of days of the week and months of the year, targeting attention, memory, and executive functions. The walking-only exercise group will follow the same walking protocol without the addition of cognitive tasks.
Outcome assessments will be conducted at baseline and after the four-week intervention period. Primary and secondary outcomes will include brain fog severity, cognitive function, depressive symptoms, sleep quality, and quality of life. All assessments will be performed by independent outcome assessors who are blinded to group allocation.
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
Outcome assessors will be independent from the intervention process and will be unaware of group assignments during baseline and post-intervention assessments.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years or older
- •Self-reported experience of brain fog symptoms (e.g., reduced attention, concentration, or -mental clarity) for at least the past 4 weeks
- •Moderate or higher brain fog severity as determined by the Turkish version of the Brain Fog Scale
- •Preserved global cognitive function (Montreal Cognitive Assessment score ≥20)
- •Ability to walk independently, with or without an assistive device
- •Ability to communicate verbally and follow instructions
- •No changes in medication and no acute illness within the past 4 weeks
- •Willingness to participate and provide written informed consent
排除标准
- •Diagnosed neurodegenerative or neurological disorders (e.g., Alzheimer's disease, stroke, or other major neurological conditions)
- •Severe psychiatric disorders
- •Medical contraindications to physical exercise
- •Severe visual or hearing impairments interfering with assessment or exercise participation
- •Inability to adhere to or complete the study procedures and exercise program
研究组 & 干预措施
Walking-Only Exercise
Participants will perform the same low-intensity walking exercise protocol without cognitive tasks, under physiotherapist supervision, three times per week for four weeks.
干预措施: Walking-Only Exercise (Other)
Cognitive Task-Based Walking Exercise
Participants will perform low-intensity walking exercises combined with concurrent cognitive tasks under physiotherapist supervision, three times per week for four weeks.
干预措施: Cognitive Task-Based Walking Exercise (Other)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: Baseline and after 4 weeks
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), which evaluates multiple cognitive domains including attention, memory, executive functions, language, and orientation. Higher scores indicate better cognitive performance.
次要结局
- Brain Fog Scale(Baseline and after 4 weeks)
- Geriatric Depression Scale(Baseline and after 4 weeks)
- Pittsburgh Sleep Quality Index(Baseline and after 4 weeks)
- World Health Organization Quality of Life Instrument-Older Adults Module(Baseline and after 4 weeks)
研究者
Emre DANSUK
Principal Investigator
Medipol University