- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867692
Effects of Aerobic Exercises on Dual-task Performance and Motor Skills in Children With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Fareeha Kausar, PP-DPT
- Phone Number: 03216758180
- Email: fareeha.kausar@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 53400
- Recruiting
- Hands on Care, Wapda Town
-
Contact:
- Fareeha Kausar, PP-DPT
- Phone Number: 03216758180
- Email: fareeha.kausar@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- IQ from 50 to 70
- Who can easily understand instructions
- Both genders are included
Exclusion Criteria:
- Hearing or vision impairment
- Any neurological/musculoskeletal disorder
- Already involved in an intervention 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 |
|---|---|
|
Active Comparator: Aerobic Exercise
|
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:
|
|
Experimental: Light Physical Activity Plan
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go
Time Frame: Baseline and 12th week
|
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
Time Frame: Baseline and 12th week
|
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
Time Frame: Baseline and 12th week
|
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
Time Frame: Baseline and 12th week
|
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
Time Frame: Baseline and 12th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fareeha Kausar, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/G-III/RCR&AHS/B42-176
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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