Cognitive ImpairmentNCT06867692
Effects of Aerobic Exercises on Dual-task Performance and Motor Skills in Children With Mild Cognitive Impairment
A study testing Aerobic Exercise and Light Physical Activity Plan in people with Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Aerobic Exercise and Light Physical Activity Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IQ from 50 to 70
- Who can easily understand instructions
- Both genders are included
Who cannot join
- Hearing or vision impairment
- Any neurological/musculoskeletal disorder
- Already involved in an intervention program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hands on Care, Wapda Town
Lahore, Punjab Province, 53400
Fareeha Kausar, PP-DPT, 03216758180, fareeha.kausar@riphah.edu.pk
About this study
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.
- Conditions
- Cognitive Impairment
- Being tested
- Aerobic Exercise, Light Physical Activity Plan
- Keywords
- Mild Cognitive Impairment, Dual-task performance, Aerobic exercises
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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:
- Simon Says: Incorporating aerobic movements like jumping jacks, running in place, etc.
- 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.
- Cool Down (5 minutes) Stretching: Gentle stretching of major muscle groups, holding each stretch for 20-30 seconds.
Light Physical Activity PlanOther
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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Light Physical Activity Plan | Experimental | Not described Receives: Other: Light Physical Activity Plan |
| Aerobic Exercise | Active comparator | Not described Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start20 Feb 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867692
- Sponsor's protocol ID
- Riphah/G-III/RCR&AHS/B42-176
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17008572Vuijk 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.
PubMed 20854287Buyukcelik 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.
PubMed 37403442
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercises on Dual-task Performance and Motor Skills in Children With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06867692
- Acronym / sponsor ID
- Riphah/G-III/RCR&AHS/B42-176
- Conditions
- Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Dual-task performance, Aerobic exercises
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Physical Activity Plan | Experimental | Other: Light Physical Activity Plan |
| Aerobic Exercise | Active comparator | Other: Aerobic Exercise |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IQ from 50 to 70
- Who can easily understand instructions
- Both genders are included
Key exclusion criteria (3 listed)
- Hearing or vision impairment
- Any neurological/musculoskeletal disorder
- Already involved in an intervention program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseWarm-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. | Other | Aerobic Exercise |
| Light Physical Activity PlanWarm-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 | Other | Light Physical Activity Plan |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 17008572Chen 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.
- Background: PubMed 20854287Vuijk 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.
- Background: PubMed 37403442Buyukcelik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fareeha Kausar, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Light Physical Activity Plan in people with Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (time frame: Baseline and 12th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.