Actively Recruiting

Phase Not Applicable
Age: 8Years - 16Years
All Genders
ID06943170

Effects of Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Overweight and Obese Children With Down Syndrome

Led by Riphah International University · Updated on 2025-04-24

22

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Down syndrome is a genetic condition caused by an extra copy of chromosome 21, affecting about 1 in 800 newborns worldwide. This research aims to compare the effects of aerobic exercise alone versus aerobic exercise combined with a low calorie diet on reducing body fat and improving body mass index (BMI) in overweight and obese children with Down syndrome. The study focuses on children aged 8 to 16 years who have a BMI at or above the 85th percentile, representing overweight or obesity status. The trial includes two groups: one group will participate in aerobic exercise combined with a low calorie diet following an intermittent fasting plan, while the other group will do aerobic exercise without any specific diet changes. The aerobic exercise involves warm-up and cool-down sessions, with the diet consisting of fasting periods increasing over 12 weeks. The study is randomized and conducted over a total duration of 10 months, with a sample size of 22 participants. Participants will be assessed using a digital weight scale and BMI calculator at the start and at 12 weeks. Additional evaluations include waist circumference, aerobic fitness via a 6-minute walk test, skin-fold measurements, perceived exertion scales, and food frequency questionnaires. The study monitors changes in adiposity and BMI to provide insights into the best approach for weight management in children with Down syndrome. Data will be analyzed using SPSS software, and all participants will be supervised closely throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 8 and 16 years
  • Both male and female children
  • BMI at or above the 85th percentile for age
  • Generally stable health without significant co-morbidities
  • Signed consent form by parents and physician approval
Not Eligible

You will not qualify if you...

  • History of any previous medical disease
  • Previous participation in any weight loss exercise program
  • Following any specific diet plan in the last 6 months
  • Taking medication that could affect weight or metabolism
  • Physical disabilities preventing safe aerobic exercise
  • Dietary restrictions or food allergies
  • Severe cognitive impairments preventing exercise participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants undergo aerobic exercise, with one group also following a low calorie diet involving intermittent fasting, to evaluate effects on adiposity and BMI.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Jannat Arshad

Lahore, Punjab Province, Pakistan, 01234

Actively Recruiting

Loading map...

Research Team

I

Imran Amjad, PhD

M

Muhammad Asif Javed, MS-PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

A Phase 2 Study of Blinatumomab With or Without Nivolumab in...

Down Syndrome

Actively Recruiting

215 locations

Chronic Health Conditions in Down Syndrome-Associated Acute ...

B Acute Lymphoblastic Leukemia Associated With Down Syndrome

Actively Recruiting

70 locations

The Impact of Weight Loss on Alzheimer's Disease Risk in Adu...

Down Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Systematic review and meta-analysis shows a specific micronutrient profile in people with Down Syndrome: Lower blood calcium, selenium and zinc, higher red blood cell copper and zinc, and higher salivary calcium and sodium.

Amene Saghazadeh, Maryam Mahmoudi, Atefeh Dehghani Ashkezari...

https://pubmed.ncbi.nlm.nih.gov/28422987

Health-related physical fitness in children and adolescents with Down syndrome and response to training.

A González-Agüero, G Vicente-Rodríguez, L A Moreno...

https://pubmed.ncbi.nlm.nih.gov/20456681