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Completed

NCT Number: NCT07396779

Cognitive Task-Based Walking Effects on Cognition, Mood, Sleep, and Quality of Life in Older Adults With Brain Fog

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.

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Key information

About this study

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.

The findings of this study are expected to provide evidence regarding the clinical effectiveness of integrating cognitive tasks into walking exercise programs and to support holistic rehabilitation strategies in older adults with brain fog.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive Task-Based Walking Exercise

Other

Participants will perform supervised low-intensity walking exercises combined with concurrent cognitive tasks targeting attention, memory, and executive functions, three times per week for four weeks. Each session will last 35 minutes, including a 5-minute warm-up, a 25-minute main walking phase, and a 5-minute cool-down.

Walking-Only Exercise

Other

Participants will perform supervised low-intensity walking exercises without concurrent cognitive tasks, three times per week for four weeks. Each session will last 35 minutes, including a 5-minute warm-up, a 25-minute main walking phase, and a 5-minute cool-down.

Primary outcomes

  1. Montreal Cognitive Assessment

    Time frame: 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.

Secondary outcomes

  1. Brain Fog Scale

    Time frame: Baseline and after 4 weeks

    Brain fog severity will be assessed using the Turkish version of the Brain Fog Scale, a self-reported questionnaire evaluating cognitive, physical, and psychological symptoms. Higher scores indicate greater severity of brain fog symptoms.

  2. Geriatric Depression Scale

    Time frame: Baseline and after 4 weeks

    Depressive symptoms will be evaluated using the Geriatric Depression Scale (GDS), a self-reported questionnaire designed to assess depressive symptoms in older adults. Higher scores indicate greater severity of depressive symptoms.

  3. Pittsburgh Sleep Quality Index

    Time frame: Baseline and after 4 weeks

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which measures subjective sleep quality and sleep disturbances over the previous month. Higher scores indicate poorer sleep quality.

  4. World Health Organization Quality of Life Instrument-Older Adults Module

    Time frame: Baseline and after 4 weeks

    Quality of life will be assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). Higher scores indicate better perceived quality of life.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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