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

Riphah International University

Status

Enrolling

Conditions

Down Syndrome

Treatments

Other: Aerobic Exercise and Low Calorie Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06943170

REC/RCR/AHS/24/0722

Details and patient eligibility

About

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.

Full description

Down syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. About 1 in 800 newborns globally experience it. The unusual phenotype that characterizes children with DS is thought to be caused by an overabundance of chromosome 21 genes or a breakdown of genetic balance. Up slanting palpebral fissures, epicanthic folds, and brachycephaly are nearly universal features of Down syndrome. Obstetricians have adopted a new paradigm for Down syndrome screening. Combined overweight and obesity prevalence was 23-70% (overweight: 13.3-52.9%; obesity: 0-62.5%). Interventions for obesity prevention and control are primarily based on diet and exercise-based programs. 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 interventions for reducing adiposity and improving BMI in this vulnerable population.

A randomized controlled trial will be conducted. The study will be conducted at Ghurki Trust and Teaching Hospital (GTTH) and 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. The Following sample characteristics will be included in the study: Children with diagnosed Down Syndrome, age (8-14 years), Both Genders (male and female), BMI (85TH-95TH percentile), generally stable health condition with parents' approval to participate in the study. The population having the following characteristics will be excluded from the study: History of any previous medical disease, previous participation in any Weight Loss Exercise Program or any specific diet plan from last 6 months, children on medication that could affect weight or metabolism, children with physical disabilities and cognitive impairments and with dietary restrictions or food allergies. The tools that will be included in the study are: Digital Weight Scale, Stadiometer, BMI calculator, Skin-Fold Caliper, 6 min walk test, rate of perceived exertion (RPE) Scale and Food Frequency Questionaire. Aerobic Exercise and Low calorie diet will be used as intervention. SPSS version 27 will be used for data analyses.

Enrollment

22 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Aerobic Exercise With Low Calorie Diet

Experimental group

Description:

EXPERIMENTAL GROUP I Detailed FITT Protocol of Aerobic Exercise Warm-Up Exercise Cool-Down Low Calorie Diet Plan: Intermittent Fasting (12 hours for first 4 weeks and 16 hours for remaining 8 weeks)

Treatment:

Other: Aerobic Exercise and Low Calorie Diet

Aerobic Exercise without low calorie diet

Experimental group

Description:

Warm Up Exercise Cool down

Treatment:

Other: Aerobic Exercise and Low Calorie Diet