| CTRI Number |
CTRI/2024/02/063306 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| 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
|
To compare Home based and Centre based exercise training in children with asthma |
|
Scientific Title of Study
|
Efficacy of Home based versus Centre based Exercise Training on Pulmonary Functions,Exercise Capacity,Sleep Quality and Quality of Life in Children with Asthma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alpna Ahuja |
| Designation |
PhD Scholar |
| Affiliation |
Regional Institute of Management and Technology |
| Address |
Physiotherapy department.Regional Institute of Management and Technology, Mandi Gobindgarh . Punjab
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9915986167 |
| Fax |
|
| Email |
alpna02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navkaran Singh |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Management and Technology |
| Address |
Physiotherapy department.Room no R-102.
Regional Institute of Management and Technology, Mandi Gobindgarh . Punjab
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
8333800002 |
| Fax |
|
| Email |
navkaran9999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alpna Ahuja |
| Designation |
PhD Scholar |
| Affiliation |
Regional Institute of Management and Technology |
| Address |
Physiotherapy Department.
Room no-PT-001.
Regional Institute of Management and Technology, Mandi Gobindgarh . Punjab
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9915986167 |
| Fax |
|
| Email |
alpna02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Civil Hospital.Sector 6.Panchkula |
|
|
Primary Sponsor
|
| Name |
Alpna Ahuja |
| Address |
Physiotherapy Department.Room No PT-001.
Regional Institute of Management and Technology.mandi Gobindgarh.Punjab. |
| 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 |
| Dr Gagan Singla |
Civil Hospital |
Pediatric OPD.Room no 18.Sector 6 .
Panchkula
HARYANA |
9855591450
gagansinglapkl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of RIMT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supervised Aerobic exercise training at home
Total Duration 8 weeks |
Web based supervised Step Aerobics will be performed using 20 cm step at home. |
| Comparator Agent |
Supervised similar exercise Training at Rehabilitation centre |
Supervised step aerobics exercises will be performed at Rehabilitation Centre.
Total duration 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with stable persistent asthma controlled by low or moderate doses of inhaled corticosteroid for atleast 6 months.
2.Absence of any acute exacerbation or change of medication in the preceding one month.
3.Children having smartphone or laptop at home |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from any other lung disorder, cardiovascular or any other musculoskeletal condition.
2. Involvement in any other exercise training program.
3. Participation in any other research studies or has language difficulties.
4. Children who are unable to follow verbal instructions and suffer from cognitive impairment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary functions
Quality of life
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Exercise Capacity
2.Sleep quality
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/03/2024 |
| 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="0"
Months="6"
Days="15" |
|
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
|
Stable persistent asthmatic children will be recruited from pediatric outpatient department of civil hospital sector 6 panchkula as per the inclusion and exclusion criteria.Randomization will be done into home based group and centre based group. Remotely we based supervised exercise training at home will be conducted thrice a week for eight weeks . Other group will do the same training in rehabilitation centre. At the end of 8 weeks both the groups will be compared to see the results. |