FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097600 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Creating a hospital-based Cardiac Rehabilitation Protocol for Children of 3 to 6 years After Heart Surgery Due to Birth Defects of the Heart: An Online Expert Study  
Scientific Title of Study   Development of an Inpatient Post-operative Cardiac Rehabilitation Protocol for Children of 3 to 6 years with Congenital Heart Disease: An E-Delphi Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnjana Javali 
Designation  Assistant professor of pediatric physiotherapy 
Affiliation  KLE Insitute of Physiotherapy 
Address  Advanced physiotherapy center, department of pediatric physiotherapy, OPD number 39, Sagar floor, Belagavi, Karnataka-590010, India

Belgaum
KARNATAKA
590010
India 
Phone  9019729812  
Fax    
Email  anjanajavali@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DrAnjana Javali 
Designation  Assistant professor of pediatric physiotherapy 
Affiliation  KLE Insitute of Physiotherapy 
Address  Advanced physiotherapy center, department of pediatric physiotherapy, OPD number 39, Sagar floor, Belagavi, Karnataka-590010, India


KARNATAKA
590010
India 
Phone  9019729812  
Fax    
Email  anjanajavali@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Tabitha Maria Lourdes Baptista 
Designation  intern physiotherapist 
Affiliation  KLE Insitute of Physiotherapy 
Address  Advanced physiotherapy center, department of pediatric physiotherapy, OPD number 39, Sagar floor, Belagavi, Karnataka-590010, India

Belgaum
KARNATAKA
590010
India 
Phone  08010996771  
Fax    
Email  tabithabaptista1234@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr. Prabhakar Kore Hospital and Research Center, Nehru Nagar, Belagavi 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar, Belagavi-590010 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnjana Javali  KAHER Institute Of Physiotherapy  Advanced physiotherapy center, department of pediatric physiotherapy, OPD number 39, Sagar floor, Belagavi, Karnataka-590010, India
Belgaum
KARNATAKA 		 9019729812

anjanajavali@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  post-operative in-patient children from 3 to 6 years of age with congenital heart defects 
 
ExclusionCriteria 
Details  children below 3years of age or above 6 years of age, pre-operative or without congenital heart defects and healthy children 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Airway Clearance-
Chest expansion
Spirometry
SpO2

Pain Management-
Wong Baker scale

Mobility & Ambulation
TUG

Posture Correction-
on observation

Aerobic Capacity-
6MWT 		 6weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome TimePoints
Airway Clearance-
Chest expansion
Spirometry
SpO2

Pain Management-
Wong Baker scale

Mobility & Ambulation
TUG

Posture Correction-
on observation

Aerobic Capacity-
6MWT 		 8 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   22/11/2025 
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="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  

Existing research strongly supports cardiac rehabilitation in adults, but limited attention is given to children aged 3 to 6 years recovering from congenital heart surgery.

Most pediatric interventions are adapted from adult programs, ignoring developmental and physiological differences.

There is a lack of randomized controlled trials assessing age specific rehabilitation in the immediate post-operative phase. 

Existing studies focus on long-term or home-based programs without clear exercise dosage or progression. 

Current pediatric protocols remain broad and fail to address cognitive, motor, and developmental needs. 

This gap highlights the urgent need for structured, age appropriate inpatient rehabilitation protocols to enhance recovery, ensure safety, and promote better functional outcomes in young children undergoing congenital heart surgery.

 
Close