NCT07396779

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 1, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Brain FogCognitive Task-Based ExerciseWalking ExerciseCognitive FunctionSleep QualityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment

    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 Outcomes (4)

  • 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

Study Arms (2)

Cognitive Task-Based Walking Exercise

EXPERIMENTAL

Participants will perform low-intensity walking exercises combined with concurrent cognitive tasks under physiotherapist supervision, three times per week for four weeks.

Other: Cognitive Task-Based Walking Exercise

Walking-Only Exercise

ACTIVE COMPARATOR

Participants will perform the same low-intensity walking exercise protocol without cognitive tasks, under physiotherapist supervision, three times per week for four weeks.

Other: Walking-Only Exercise

Interventions

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.

Cognitive Task-Based Walking Exercise

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.

Walking-Only Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emre Dansuk

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental FatigueCognitive DysfunctionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorCognition DisordersNeurocognitive DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Emre Dansuk, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be independent from the intervention process and will be unaware of group assignments during baseline and post-intervention assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a single-center, prospective, randomized controlled trial comparing cognitive task-based walking exercise with walking-only exercise in older adults with brain fog. Participants will undergo supervised low-intensity walking exercises three times per week for four weeks. Outcomes will be evaluated at baseline and post-intervention to determine the effects on cognitive function, depression, sleep quality, and quality of life.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

February 1, 2026

Primary Completion

April 22, 2026

Study Completion

April 22, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations