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

NCT06943170 | Recruiting DMC

• 1 other identifier: REC/RCR/AHS/24/0722
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Digital weight Scale

  A calibrated scale is used to measure participants' weight accurately. It should be placed on a level surface and calibrated regularly to ensure precision. 2\. S A calibrated scale is used to measure participants' weight accurately. It should be placed on a level surface and calibrated regularly to ensure precision. 2\. S Tool to measure participant's weight accurately.

  Baseline and 12th week

Secondary Outcomes (1)

• Body Mass Index (BMI)

  Baseline and 12th week

Other Outcomes (2)

• Waist Circumference Measurements

  baseline and 12th week

• Skin Fold thickness

  Baseline and 12th week

Study Arms (2)

Aerobic Exercise With Low Calorie Diet

EXPERIMENTAL

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)

Other: Aerobic Exercise and Low Calorie Diet

Aerobic Exercise without low calorie diet

EXPERIMENTAL

Warm Up Exercise Cool down

Other: Aerobic Exercise and Low Calorie Diet

Interventions

Aerobic Exercise and Low Calorie Diet OTHER

Group A: Aerobic Exercise with Low calorie diet Group B: Aerobic Exercise without Low Calorie Diet

Aerobic Exercise With Low Calorie Diet; Aerobic Exercise without low calorie diet

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• History of any previous medical disease.
• Previous Participation in any Weight Loss Exercise Program.
• Participants following any specific diet plan from last 6 months.
• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jannat Arshad

Lahore, Punjab Province, 01234, Pakistan

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• Bull MJ. Down Syndrome. N Engl J Med. 2020 Jun 11;382(24):2344-2352. doi: 10.1056/NEJMra1706537. No abstract available.

  PMID: 32521135 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Down Syndrome; Obesity

Interventions

Exercise; Caloric Restriction

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jannat Arshad, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group and the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Experimental Group I: Aerobic Exercise with Low Calorie Diet. * Experimental Group II: Aerobic Exercise without Low Calorie Diet. FITT Principle The exercise groups will follow a supervised 12-week aerobic training intervention program. The duration of each aerobic exercise session will be set at 10 min for the first two weeks, 20 min for the next two weeks, and 30 min for the remaining eight weeks. 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: February 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)