| CTRI Number |
CTRI/2024/07/069960 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Aerobic exercise for overweight Childern with neurodevelopmental disorders |
|
Scientific Title of Study
|
Effectiveness of aerobic exercise intervention in overweight and obesity childern with Neurodevelopmental disorders |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samudyatha KM |
| Designation |
postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Medical sciences and Hospital Manjushree nagar Sattur Dharwad karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7022635357 |
| Fax |
|
| Email |
samudyathakenkare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samudyatha KM |
| Designation |
postgraduate student |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Medical sciences and Hospital Manjushree nagar Sattur Dharwad karnataka 580009
KARNATAKA
580009
India |
| Phone |
7022635357 |
| Fax |
|
| Email |
samudyathakenkare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay T Parmar |
| Designation |
Principal professor PG Guide |
| Affiliation |
SDM college of physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Medical sciences and Hospital Manjushree nagar Sattur Dharwad karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
|
| Email |
sanjaytparmar777@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital Manjushree Nagar Sattur Dharwad-580009
Karnataka India |
|
|
Primary Sponsor
|
| Name |
Samudytha K.M |
| Address |
SDM College of Medical sciences and Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Samudyatha K M |
SDM Hospital Dharwad |
OPD number 13 Paediatric Physiotherapy SDM medical hospital Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA |
7022635357
samudyathakenkare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F848||Other pervasive developmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic exercise training, |
This study involves children aged 5-15 with neurodevelopmental disorders participating in a 12-week exercise program, meeting three times weekly for 60-minute sessions. Each session includes a warm-up, upper and lower limb strengthening exercises, aerobic activities, and a cool-down. Exercise intensity is progressively increased over time. The program aims to improve physical fitness and overall health outcomes in these children. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children falling in the age group of 5-15 years
Subjects who are overweight and obesity whose BMI is more or equal to 85th percentile
Children who confirmed with NDD by the pediatrician
The children who can follow the simple commands
The children whose parents are willing their child’s participation
|
|
| ExclusionCriteria |
| Details |
the children who are unable to walk
the children, whose parents are not willing their child’s participation.
the children who are less than 5 years of age.
The children who are diagnosed with congestive Heart failure, vascular disease, renal disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BMI- Body Mass Index |
BMI- Body Mass Index is calculated at 0 day 4th week 8th week and 12th week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
waist circumference
|
Waist circumference measures at the minimum circumference between the iliac crest and the rib cage. Subject was in the light clothing and the measurement was taken with anthropometric tape At 0th day 4th week 8th week and 12th week of intervention |
| PeDsQL measure |
is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. this is taken at 0th day and 12th week of intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study focuses on children aged 5-15 diagnosed with neurodevelopmental disorders, aiming to evaluate the effects of a structured exercise program. Before commencing, parental consent and demographic data are obtained, including weight and height measurements. Maximum heart rate (HRmax) is calculated using the formula HRmax = 208 - age (0.8).
Each session, lasting 60 minutes, occurs 3 days per week over 12 weeks. It begins with a 10-minute warm-up comprising walking, upper and lower body exercises, and passive stretching. Following this, a 20-minute strengthening segment includes exercises like biceps curls and hip extensions. Intensity increases progressively every 3 weeks.
Aerobic exercises such as treadmill and cycling follow, starting at 65% of HRmax and progressing to 75% by week 12. Sessions conclude with a 7-minute cooldown involving overall body stretching and deep breathing.
Ethical clearance is obtained, and data collection occurs at pediatric physiotherapy OPDs and special schools in Hubli-Dharwad. The study uses a paired t-test to assess baseline and post-intervention outcomes, tailored to each participant’s condition. |