- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07396779
Cognitive Task-Based Walking Effects on Cognition, Mood, Sleep, and Quality of Life in Older Adults With Brain Fog
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34815
- Emre Dansuk
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 4 weeks
|
|
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.
|
Baseline and after 4 weeks
|
|
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.
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Baseline and after 4 weeks
|
|
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.
|
Baseline and after 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emre Dansuk, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurocognitive Disorders
- Cognition Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Fatigue
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Cognitive Dysfunction
- Sleep Initiation and Maintenance Disorders
- Mental Fatigue
Other Study ID Numbers
- E-10840098-202.3.02-7890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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