Down SyndromeNCT06943170
Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Down Syndrome
A study testing Aerobic Exercise and Low Calorie Diet in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Aerobic Exercise and Low Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jannat Arshad
Lahore, Punjab Province, 01234
Jannat Arshad, MS-PT, 923234081894, drjannatarshad@gmail.com
About this study
Official title: Effects of Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Overweight and Obese Children With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Aerobic Exercise and Low Calorie Diet
- Keywords
- Down Syndrome, Obesity, Adiposity, Body Mass Index (BMI)
- Medical subject headings
- Down Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise and Low Calorie DietOther
Group A: Aerobic Exercise with Low calorie diet Group B: Aerobic Exercise without Low Calorie Diet
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Aerobic Exercise and Low Calorie Diet |
| Aerobic Exercise without low calorie diet | Experimental | Warm Up Exercise Cool down Receives: Other: Aerobic Exercise and Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
- S Tool to measure participant's weight accurately.
Measured: Baseline and 12th week
Secondary outcomes (1)
Body Mass Index (BMI)
To measure particpants adiposity
Measured: Baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Feb 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jannat Arshad, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943170
- Sponsor's protocol ID
- REC/RCR/AHS/24/0722
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32029743Bull MJ. Down Syndrome. N Engl J Med. 2020 Jun 11;382(24):2344-2352. doi: 10.1056/NEJMra1706537. No abstract available.
PubMed 32521135Ergaz-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.
PubMed 28386951Saghazadeh 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.
PubMed 28422987Krivega 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.
PubMed 36459979Gonzalez-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.
PubMed 20456681
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise With and Without Low Calorie Diet on Adiposity and BMI of Overweight and Obese Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06943170
- Acronym / sponsor ID
- REC/RCR/AHS/24/0722
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Obesity, Adiposity, Body Mass Index (BMI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise With Low Calorie Diet | Experimental | Other: Aerobic Exercise and Low Calorie DietEXPERIMENTAL 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) |
| Aerobic Exercise without low calorie diet | Experimental | Other: Aerobic Exercise and Low Calorie DietWarm Up Exercise Cool down |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise and Low Calorie DietGroup A: Aerobic Exercise with Low calorie diet Group B: Aerobic Exercise without Low Calorie Diet | Other | Aerobic Exercise With Low Calorie Diet, Aerobic Exercise without low calorie diet |
Primary outcome
Digital weight Scale
Time frame: Baseline and 12th week
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.
1 secondary outcome
Body Mass Index (BMI)
Time frame: Baseline and 12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 32029743Antonarakis 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.
- Background: PubMed 32521135Bull MJ. Down Syndrome. N Engl J Med. 2020 Jun 11;382(24):2344-2352. doi: 10.1056/NEJMra1706537. No abstract available.
- Background: PubMed 28386951Ergaz-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.
- Background: PubMed 28422987Saghazadeh 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.
- Background: PubMed 36459979Krivega 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.
- Background: PubMed 20456681Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jannat Arshad, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Low Calorie Diet in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital weight Scale (time frame: Baseline and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943170, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.