NCT07120074

Brief Summary

This study aims to investigate the effects of dual-task exercises on balance and cognitive function in individuals with varying levels of physical performance. Dual-task training, which involves performing cognitive and motor activities simultaneously, has been shown to improve functional mobility, especially in older adults and patients with neurological conditions. However, limited data exist on how these effects differ among individuals with different physical capacities. The findings of this study will contribute to understanding the therapeutic value of dual-task exercises in promoting both physical and cognitive health.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 20, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

July 20, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

dual taskdenge

Outcome Measures

Primary Outcomes (3)

  • Single-Leg Stance Test

    First, the participant will be asked which foot they prefer to stand on or which foot makes them feel more stable. Then, they will be instructed to distribute their weight evenly on both feet and, while maintaining this position, lift one foot off the ground. The timer will start as soon as the participant lifts their foot. The timer will be stopped if any signs of balance disturbance occur, such as the lifted foot making contact with the ground, the standing foot jumping, or the participant needing to support themselves in order to maintain balance. The longer an individual is able to maintain a single-leg stance, the better their static balance is considered to be.

    At baseline and after 6 weeks

  • Y Balance Test

    The Y-Balance Test (YBT) is a widely used, valid, and reliable tool for assessing dynamic balance. In this test, the participant stands on one leg and reaches in specific directions (anterior, posteromedial, and posterolateral) with the opposite leg. In this study, only the anterior reach direction was assessed. Participants performed three practice trials for familiarization, followed by three recorded trials. During the test, the participant stood barefoot on a flat surface, maintaining balance on one leg. With the contralateral leg, they reached forward as far as possible and returned to the starting position without losing balance. The distance was measured from the tip of the big toe of the stance foot to the point where the toes of the reaching foot touched the ground. The longest distance achieved among the trials was used for statistical analysis. Greater reach distances were interpreted as better dynamic balance performance.

    At baseline and after 6 weeks exercise program

  • Stroop Test

    The aim of the Stroop test is to evaluate the person's speed of processing information, especially simple and complex attention, inhibition ability, ability to be resistant to interference. The test to be used in our study includes 3 steps: In the first step, the person is asked to say the colours of the boxes in the form, in the second step to read the words in the form quickly, and in the last step to say the colours of the words. The time taken to complete each step is noted. The time difference between steps 2 and 3, the error made and the self-correction scores are recorded.

    At baseline and after 6 weeks exercise program

Secondary Outcomes (1)

  • Health-Related Quality of Life assessed by the SF-36 Questionnaire

    At baseline and after 6 weeks exercise program

Study Arms (2)

Highly active dual-task exercise group

ACTIVE COMPARATOR

Dual-task exercises involve the simultaneous performance of a motor task (e.g., walking, balancing, carrying an object) and a cognitive task (e.g., counting, word recall, attention tasks). These exercises simulate real-life situations that require multitasking and aim to improve motor-cognitive integration. They have been shown to be effective in enhancing balance, gait, and cognitive functions, particularly in older adults, individuals with neurological disorders, and those at risk of falling.Based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) scores, participants were categorized into two groups: highly active and less active. Both groups underwent the same dual-task exercise protocol.

Other: Exercise

Low-activity dual-task exercise group

ACTIVE COMPARATOR

Dual-task exercises involve the simultaneous performance of a motor task (e.g., walking, balancing, carrying an object) and a cognitive task (e.g., counting, word recall, attention tasks). These exercises simulate real-life situations that require multitasking and aim to improve motor-cognitive integration. They have been shown to be effective in enhancing balance, gait, and cognitive functions, particularly in older adults, individuals with neurological disorders, and those at risk of falling. Based on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) scores, participants were categorized into two groups: highly active and less active. Both groups underwent the same dual-task exercise protocol.

Other: Exercise

Interventions

A low-activity exercise group, and highly active dual-task exercise group determined based on physical performance level, was subjected to 6 weeks of dual-task exercises aimed at improving balance and cognitive function. Dual-task refers to performing two different tasks simultaneously. In the first week, tasks included generating 3- and 4-letter words while standing in a tandem position, reciting the months and seasons in order while shifting weight forward and backward on a balance board, and performing addition and subtraction tasks while walking. The difficulty level of the tasks was increased each week.

Highly active dual-task exercise groupLow-activity dual-task exercise group

Eligibility Criteria

Age20 Months - 50 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 20 and 50 years Adequate cognitive function to understand instructions and participate in the study Willingness and ability to participate regularly in the exercise program Ability to comprehend and follow the study procedures

You may not qualify if:

  • Diagnosed with rheumatoid arthritis Diagnosed with systemic lupus erythematosus (SLE) Diagnosed with Parkinson's disease Diagnosed with multiple sclerosis History of stroke Diagnosed with Alzheimer's disease or other dementias Diagnosed with scoliosis causing physical limitation History of lower limb fractures Presence of foot or ankle tendonitis Diagnosed with color blindness or legal blindness History of major surgery (e.g., orthopedic, spinal, abdominal) within the past 6 months Irregular attendance or non-compliance with the exercise protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Istanbul, MALTEPE, 34844, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • tulin unal

    bağlantısız

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SÜDAYE ÜNAL

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants aged between 20 and 50 years were divided into two groups based on their physical performance levels. Both groups performed dual-task exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 20, 2025

First Posted

August 13, 2025

Study Start

August 3, 2025

Primary Completion

October 4, 2025

Study Completion

November 18, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Anonymized demographic information of participants (e.g., age, gender, educational status) Balance assessment scores before and after dual-task exercises Cognitive function assessment results (Stroop test) Quality of life evaluation results (SF-36)

Shared Documents
STUDY PROTOCOL, SAP

Locations