Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Down Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercise and Low Calorie Diet.
- Who it may be relevant to
- Registry conditions: Down Syndrome. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Overweight and Obese Children With Down Syndrome
Overview
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.
Detailed 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.
Interventions
- Other Aerobic Exercise and Low Calorie Diet
Group A: Aerobic Exercise with Low calorie diet Group B: Aerobic Exercise without Low Calorie Diet
Primary outcome measures
- Digital weight Scale [Time frame: Baseline and 12th week]
Secondary outcome measures (1)
- Body Mass Index (BMI) [Time frame: Baseline and 12th week]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Pakistan · 1 center
- Jannat Arshad — Lahore
Publications
- Antonarakis SE, Skotko BG, Rafii MS, Strydom A, Pape SE, Bianchi DW, Sherman SL, Reeves RH. Down syndrome. Nat Rev Dis Primers. 2020 Feb 6;6(1):9. doi: 10.1038/s41572-019-0143-7. PMID 32029743
- Bull MJ. Down Syndrome. N Engl J Med. 2020 Jun 11;382(24):2344-2352. doi: 10.1056/NEJMra1706537. No abstract available. PMID 32521135
- Ergaz-Shaltiel Z, Engel O, Erlichman I, Naveh Y, Schimmel MS, Tenenbaum A. Neonatal characteristics and perinatal complications in neonates with Down syndrome. Am J Med Genet A. 2017 May;173(5):1279-1286. doi: 10.1002/ajmg.a.38165. Epub 2017 Apr 6. PMID 28386951
- Saghazadeh A, Mahmoudi M, Dehghani Ashkezari A, Oliaie Rezaie N, Rezaei N. 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. PLoS One. 2017 Apr 19;12(4):e0175437. doi: 10.1371/journal.pone.0175437. eCollection 2017. PMID 28422987
- Krivega M, Stiefel CM, Storchova Z. Consequences of chromosome gain: A new view on trisomy syndromes. Am J Hum Genet. 2022 Dec 1;109(12):2126-2140. doi: 10.1016/j.ajhg.2022.10.014. PMID 36459979
- Gonzalez-Aguero A, Vicente-Rodriguez G, Moreno LA, Guerra-Balic M, Ara I, Casajus JA. Health-related physical fitness in children and adolescents with Down syndrome and response to training. Scand J Med Sci Sports. 2010 Oct;20(5):716-24. doi: 10.1111/j.1600-0838.2010.01120.x. PMID 20456681
Identifiers
NCT: NCT06943170 · REC/RCR/AHS/24/0722