NCT06943170 Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Down Syndrome
| NCT ID | NCT06943170 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riphah International University |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2025-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2025-02-15 with a primary completion date of 2025-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Down syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. A calibrated weight scale is used to measure participants' weight accurately. A stadiometer measures participants' height to the nearest millimeter. A flexible non-stretchable waist circumference tape is used to assess abdominal obesity. Body mass index (BMI, ratio of height and weight, expressed as kg/m2 6-Min Walk is a test to evaluate aerobic fitness level. Brisk Walk, a type of moderate intensity aerobic exercise can be an effective component of a weight loss program for overweight and obese children with Down syndrome. The aim of this study to compare the effects of aerobic exercise alone versus aerobic exercise combined with a low calorie diet, to provide insights into optimal inte A randomized controlled trial will be conducted. The study will be conducted at Rehab Clinic, Lahore in a total duration of 10 months. Sample size will be 22. There will be two study groups, Group I: Aerobic Exercise with Low calorie diet and Group II: Aerobic Exercise without Low calorie diet. Non-Probability Convenient sampling technique will be used to collect the data.
Eligibility Criteria
Inclusion Criteria: * Age (8-16) years. * Both Genders (Male and Female). * BMI-for-age percentile (at or above 85th percentile is overweight, and at or above 95th percentile is considered as obese) * Children with generally stable health condition, without significant co-morbidities that might affect diet or exercise interventions. * Consent form signed by parents, along with written approval by the physician. Exclusion Criteria: * History of any previous medical disease. * Previous Participation in any Weight Loss Exercise Program. * Participants following any specific diet plan from last 6 months. * Exclusion of children on medication that could affect weight or metabolism. * Children with physical disabilities that prevent them from safely participating in aerobic exercise. * Children with dietary restrictions or food allergies. * Children with severe cognitive impairments that prevent them from engaging in exercise program.
Contact & Investigator
Jannat Arshad, MS-PT
PRINCIPAL INVESTIGATOR
Riphah International University
Frequently Asked Questions
Who can join the NCT06943170 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06943170 currently recruiting?
Yes, NCT06943170 is actively recruiting participants. Contact the research team at imran.amjad@riphah.edu.pk for enrollment information.
Where is the NCT06943170 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT06943170 clinical trial?
NCT06943170 is sponsored by Riphah International University. The principal investigator is Jannat Arshad, MS-PT at Riphah International University. The trial plans to enroll 22 participants.