NCT06867692

Brief Summary

Cognition refers to the mental processes involved in gaining knowledge and understanding, encompassing aspects such as thinking, knowing, remembering, judging, and problem-solving. These processes include attention, memory, executive functions, perception, language, and visuospatial skills. In children, cognitive development is critical for academic success, social interactions, and daily living activities. In the context of mild cognitive impairment (MCI) in children, cognitive processes may be less efficient or slower than in typically developing peers.This can affect their ability to perform tasks that require simultaneous cognitive and motor functions, known as dual tasks. Aerobic exercises are known to provide numerous cognitive and physical benefits, but their specific impact on children with MCI has not been thoroughly investigated. The aim of study is to analyze the effects of aerobic exercises on dual-task performance and motor skills in children with mild cognitive impairment.The current study will be randomized control trial; data will be collected from Government special education center Johar Town. The study will include patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be both genders, having age between7 to 12, children with IQ ranging from 50-70, who are cooperative. Children with Hearing or vision impairment, any neurological/musculoskeletal disorder or already involved in an intervention program will also be excluded from the study. Experimental group will perform a structured aerobic exercise program and control group will do its daily routine activities. The intervention group will receive 3 sessions per week for 12weeks. Each session lasted 45 min on average. Outcomes to be analyzed will be dual-task performance and motor skills. Tools used for data collection will be Timed Up and Go, Single Leg Stance, Tandem Stance, and 30-second Sit-to-Stand tests and TGMD-2. Data will be analyzed through SPSS version 26.00.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 20, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

Mild Cognitive ImpairmentDual-task performanceAerobic exercises

Outcome Measures

Primary Outcomes (5)

  • Timed Up and Go

    In this test, the child wears their usual footwear and is instructed to stand up from a chair, walk a designated distance of 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down. The time taken to complete the task 10 is recorded in seconds using a stopwatch.

    Baseline and 12th week

  • Single Leg Stance

    During the test, the child is instructed to lift one leg and stand unassisted, maintaining this position for as long as possible. The duration until the foot touches the ground is timed in seconds using a stopwatch.

    Baseline and 12th week

  • Tandem Stance

    In the Tandem Stance test, the child is asked to stand with one foot directly in front of the other in a heel-to-toe position, thereby narrowing the base of support to assess static balance. The test ends when the child can no longer maintain this position, and the duration is timed in seconds using a stopwatch. If the child can hold the tandem stance for 30 seconds, the test is not repeated.

    Baseline and 12th week

  • 30-second Sit-to-Stand tests

    In this test, the child is instructed to stand up from a chair (seat height 43 cm) with a straight back and no armrests, keeping their arms crossed over their chest, then sit back down and repeat this for 30 seconds. The number of times the child stands up in 30 seconds is recorded.

    Baseline and 12th week

  • TGMD-2

    The TGMD-2 (Test of Gross Motor Development, Second Edition) is a widely used assessment tool designed to evaluate the gross motor skills of children. It assesses both locomotor (movement from one place to another) and object control (handling and manipulation of objects) skills.

    Baseline and 12th week

Study Arms (2)

Light Physical Activity Plan

EXPERIMENTAL
Other: Light Physical Activity Plan

Aerobic Exercise

ACTIVE COMPARATOR
Other: Aerobic Exercise

Interventions

Warm-Up (5 minutes): Marching in Place: 2 minutes of marching to elevate heart rate. Arm Circles: 1 minute of small and large arm circles. Side Steps with Arm Swings: 2 minutes of stepping side to side with gentle arm swings. Main Exercise Routine (35 minutes): Walking/Jogging Intervals: 10 minutes alternating between 1 minute of walking and 1 minute of jogging. Jumping rope: 10 minutes of rope jumping. As a pre-determined routine to maintain consistency. Aerobic Games: 10 minutes of structured games like: 1. Simon Says: Incorporating aerobic movements like jumping jacks, running in place, etc. 2. Obstacle Course: Pre-planned course involving stepping over objects, crawling, and balancing. Ball Activities: 5 minutes of activities such as throwing and catching, or dribbling a ball around cones. 3. Cool Down (5 minutes) Stretching: Gentle stretching of major muscle groups, holding each stretch for 20-30 seconds.

Aerobic Exercise

Warm-Up (5 minutes): Gentle Walking: 2 minutes at a slow pace. Light Arm Movements: 1 minute of gently moving arms up and down. Side Steps: 2 minutes of gentle side stepping. 2\. Main Activity Routine (35 minutes): Stretching Exercises: 10 minutes of gentle stretching, focusing on flexibility. Balance Activities: 10 minutes of activities such as: Standing on One Leg: Holding balance for 10-15 seconds on each leg. Heel-to-Toe Walking: Walking in a straight line, placing the heel of one foot directly in front of the toes of the other foot. 3. Light Coordination Games: 10 minutes of low-intensity activities like: Passing a Ball: Gently passing a ball back and forth with a partner. Basic Catch and Throw: Simple throw and catch exercises with a soft ball. Guided Relaxation: 5 minutes of guided relaxation techniques, including deep breathing and visualization. 4. Cool Down (5 minutes) Gentle Stretching: Stretching major muscle groups, holding each stretch for 20-30 second

Light Physical Activity Plan

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • IQ from 50 to 70
  • Who can easily understand instructions
  • Both genders are included

You may not qualify if:

  • Hearing or vision impairment
  • Any neurological/musculoskeletal disorder
  • Already involved in an intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hands on Care, Wapda Town

Lahore, Punjab Province, 53400, Pakistan

RECRUITING

Related Publications (3)

  • Chen CY, Lawlor JP, Duggan AK, Hardy JB, Eaton WW. Mild cognitive impairment in early life and mental health problems in adulthood. Am J Public Health. 2006 Oct;96(10):1772-8. doi: 10.2105/AJPH.2004.057075.

    PMID: 17008572BACKGROUND
  • Vuijk PJ, Hartman E, Scherder E, Visscher C. Motor performance of children with mild intellectual disability and borderline intellectual functioning. J Intellect Disabil Res. 2010 Nov;54(11):955-65. doi: 10.1111/j.1365-2788.2010.01318.x. Epub 2010 Sep 20.

    PMID: 20854287BACKGROUND
  • Buyukcelik NM, Yigit S, Turhan B. An investigation of the effects of dual-task balance exercises on balance, functional status and dual-task performance in children with Down syndrome. Dev Neurorehabil. 2023 Jul;26(5):320-327. doi: 10.1080/17518423.2023.2233031. Epub 2023 Jul 4.

    PMID: 37403442BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fareeha Kausar, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fareeha Kausar, PP-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 10, 2025

Study Start

February 20, 2025

Primary Completion

July 15, 2025

Study Completion

July 30, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations