| CTRI Number |
CTRI/2024/01/061000 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Aerobic Exercises on Executive Functions of Pre-adolescent children with low cardiorespiratory function: A look at aerobic activities and brain functions in Pre-adolescents |
|
Scientific Title of Study
|
Effects of Aerobic Exercise on Executive Functions of Pre-Adolescent Children with Impaired Cardio Respiratory Function : Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsana Nagar |
| Designation |
PG Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi -92 |
| Address |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi
East
DELHI
110092
India |
| Phone |
9599547674 |
| Fax |
|
| Email |
jyotsananagar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi -92 |
| Address |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi
East
DELHI
110092
India |
| Phone |
|
| Fax |
|
| Email |
nidhi.singh2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsana Nagar |
| Designation |
PG Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi -92 |
| Address |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma
East
DELHI
110092
India |
| Phone |
9599547674 |
| Fax |
|
| Email |
jyotsananagar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sarvodaya Co-Ed Vidyalaya A-2 Paschim Vihar, New Delhi-110063 |
|
|
Primary Sponsor
|
| Name |
Jyotsana Nagar |
| Address |
Amar Jyoti Institute of Physiotherapy, Vikas Mary, Karkardooma, Delhi -92 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| Dr Nidhi Singh |
Govt Sarvodaya Co-ed Vidyalaya |
A-2,Paschim Vihar,New Delhi-110063
West
DELHI |
9599547674
nidhi.singh2411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board-Ethical Committee |
Approved |
| Govt Sarvodaya Co-Ed Vidayalaya A-2 Paschim Vihar Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-adolescent children with Impaired cardiorespiratory function (20 meter shuttle run test) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A talk will be given about the importance of aerobic exercises |
At the beginning of the Study for 15 to 20 minutes |
| Intervention |
Aerobic Exercises |
Intervention will be given for 3 days a week for 8 weeks for 40 to 50 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.School going children from ages 6-12 years who perform poorly on the 20 meter shuttle run test.
2.Children who have the ability to understand, read and speak basic English. |
|
| ExclusionCriteria |
| Details |
1.Children preforming good on the 20 meter shuttle run test.
2.Children with diseases such as diabetes mellitus,epilepsy,asthma,cognitive disorders,sleep disturbances etc.
3.Children with history of psychiatric disorders such as ADHD, Schizophrenia, Bipolar disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The Coloured Progressive Matrices test
|
At Baseline and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Matching Familiar Figure task
2.Circle drawing test
3.Backward word test |
At Baseline & at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
07/01/2024 |
| 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 Yet Recruiting |
| 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
|
This study is a randomised control trial. The purpose of this study is to see the effects of aerobic exercises on executive functions of pre-adolescent children with impaired cardiorespiratory function. The study will be conducted at Govt. Sarvodaya Co-ed Vidyalaya A-2 Paschim Vihar, New Delhi -110063. The alternate hypothesis is that there is significant effect of aerobic exercises on executive functions of pre-adolescent children with impaired cardiorespiratory function. The outcome measures are colored progressive matrices test, circle drawing test, matching familiar figure task, backward word span test. |