ClinConnect ClinConnect Logo
Search / Trial NCT06943170

Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Down Syndrome

Launched by RIPHAH INTERNATIONAL UNIVERSITY · Apr 17, 2025

Trial Information

Current as of June 06, 2025

Recruiting

Keywords

Down Syndrome, Obesity, Adiposity, Body Mass Index (Bmi)

ClinConnect Summary

This clinical trial is studying how aerobic exercise affects weight and body fat in children with Down syndrome. Researchers want to find out if combining aerobic exercise with a low-calorie diet helps children lose weight more effectively than just doing exercise alone. The trial will take place over 10 months at a rehab clinic in Lahore and will involve 22 children aged between 8 and 16 years. Participants will be randomly divided into two groups: one group will follow a low-calorie diet along with exercise, while the other group will only do the exercise.

To be eligible for this trial, children should be between 8 and 16 years old, generally healthy, and classified as overweight or obese based on their body mass index (BMI). Parents will need to sign a consent form, and the child's physician must approve their participation. Unfortunately, children with certain medical conditions, previous involvement in weight loss programs, or those on specific diets won't be able to join. Throughout the trial, participants can expect to engage in aerobic exercises like brisk walking, and the researchers will closely monitor their weight and fitness levels. This study aims to provide helpful insights into the best approaches for managing weight in children with Down syndrome.

Gender

ALL

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.

About Riphah International University

Riphah International University is a leading educational institution based in Pakistan, dedicated to advancing healthcare and medical research through innovative clinical trials. With a commitment to excellence in research and education, Riphah emphasizes ethical standards and scientific integrity in its clinical studies. The university collaborates with various stakeholders, including healthcare professionals and industry partners, to enhance patient outcomes and contribute to the global body of medical knowledge. Through its robust research programs, Riphah International University aims to foster a culture of inquiry and improve healthcare delivery both locally and internationally.

Locations

Lahore, Punjab, Pakistan

Patients applied

0 patients applied

Trial Officials

Jannat Arshad, MS-PT

Principal Investigator

Riphah International University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported