| CTRI Number |
CTRI/2023/11/059481 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey of physical activity levels, facilitators and barriers of physical activity in children aged 8-14 years after 6-9 months of surgery for congenital heart disease |
|
Scientific Title of Study
|
Assessment of physical activity levels, facilitators and barriers of physical activity in
children aged 8-14 years after surgery for congenital heart disease post 6-9 months– A survey.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADITI L SOMAN |
| Designation |
assistant professor, Department of Kinesiotherapy |
| Affiliation |
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE |
| Address |
DECCAN EDUCATION SOCIETYS
BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, KINESIOTHERAPY LAB,
FERGUSSON COLLEGE CAMPUS, Shivajinagar
Pune
MAHARASHTRA
411004
India |
| Phone |
08788123192 |
| Fax |
|
| Email |
aditi.soman@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
ADITI L SOMAN |
| Designation |
assistant professor |
| Affiliation |
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE |
| Address |
DECCAN EDUCATION SOCIETYS
BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS, Shivajinagar
Pune
MAHARASHTRA
411004
India |
| Phone |
08788123192 |
| Fax |
|
| Email |
aditi.soman@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Ronit Patil |
| Designation |
Student Maters of Physiotherapy |
| Affiliation |
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE |
| Address |
DECCAN EDUCATION SOCIETYS
BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, KINESIOTHERAPY LAB,
FERGUSSON COLLEGE CAMPUS, Shivajinagar
BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS, ShivajiNagar
Pune
MAHARASHTRA
411004
India |
| Phone |
9403552665 |
| Fax |
|
| Email |
patilronit30@gmail.com |
|
|
Source of Monetary or Material Support
|
| no monetary/ Material support obtained. Self funded project.
Study participants are Patients visiting OPD of Deccan Education Societys Brijlal Jindal College of Physiotherapy and Spandan Heart Hospital, Jalgaon. |
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
self funded
it is a PG thesis project. Survey by nature. it just needs pen, papers to print self made questionnaire and physical activity questionnaire. Also, Some travel expense to reach study center. these all expenses will be born by PG student and PI/Guide if required. |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not received self funded |
None |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditi Laukik Soman |
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY |
DECCAN EDUCATION SOCIETYS
BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, FERGUSSON COLLEGE CAMPUS,
Pune
MAHARASHTRA |
08788123192
aditi.soman@despune.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q249||Congenital malformation of heart,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children undergone surgery for CHD 6 month ago and up to 9 months.
2. Children aged 8-14 years
|
|
| ExclusionCriteria |
| Details |
1. children who have not reached the minimum post-surgery timeframe of 6 months
2. children who are beyond the maximum post-surgery timeframe of 9 months
3. Children with severe complications like heart rhythm disorders, kidney disorders, stroke
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • C-PAQ Questionnaire |
ONCE ONLY AFTER 6-9 MONTHS OF SURGERY FOR CONGNITAL HEART DISEASES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| self made questionnaire to assess of physical activity levels, facilitators & barriers of physical activity(Fcae validated) |
once only after inclusion in study & after administration of Primary outcome measure |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
| Postoperative cardiac rehabilitation could play a role in the promotion of physical activity, but unlike the widespread use of postoperative cardiac rehabilitation in adults, rehabilitation programs are not part of routine care for children after heart surgery to support an active lifestyle or good physical fitness. There are evidences which have reported that children with CHD are less active compared to their peers and more likely to be overweight There may be reluctance on the part of patients, their parents and/or health care providers based on fear of risks or side effects, lack of knowledge on the potential benefits, or absence of pediatric cardiac rehabilitation services. Despite the potential benefits of physical activity and exercise and ensuing practice recommendations, it remains unclear which factors play a role in this relative underuse Hence an attempt will be made to find out physical activity levels, facilitators and barriers for physical activity in children’s undergone surgery for CHD |
|