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CTRI Number  CTRI/2025/01/079114 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of Exercise and play approach with chest massage on breathing and markers of swelling in children with bronchial asthma. 
Scientific Title of Study   The effect of Exercplay and Thoracic lymphatic pump technique on functional capacity and inflammatory parameters in children with bronchial 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  Preethi Gokulan 
Designation  PhD STUDENT 
Affiliation  Saveetha college of physiotherapy, Saveetha University 
Address  room no: 5B4,5th floor,Saveetha College of Physiotherapy, AHS BUILDING,SIMATS, Thandalam Chennai-128
Saveetha College of Physiotherapy, Thandalam Thandalam Chennai-128
Chennai
TAMIL NADU
600128
India 
Phone  08838998256  
Fax    
Email  preethi.scpt@saveetha.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Rekha 
Designation  Professor 
Affiliation  Saveetha college of physiotherapy, Saveetha University 
Address  Room No:5B cardio room, 5th floor, Saveetha College of Physiotherapy, AHS BUILDING, SIMATS, Thandalam. Chennai-128

Chennai
TAMIL NADU
600077
India 
Phone  8838998256  
Fax    
Email  futurdreams88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Preethi G 
Designation  PhD STUDENT 
Affiliation  Saveetha college of physiotherapy, Saveetha University 
Address  AHS BUILDING,5th floor,Saveetha College of Physiotherapy, SIMATS, Thandalam Chennai-128
Saveetha college of physiotherapy, SIMATS, Thandalam, India, Tamil nadu, Chennai
Chennai
TAMIL NADU
600039
India 
Phone  8838998256  
Fax    
Email  preethigokulan@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital,SIMATS,162, Poonamallee High Road, Poonamallee, Chennai,Kuthambakkam, Tamil Nadu 600077 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Rekha  Saveetha Medical College Hospital  room no: 5B4,5th floor,Saveetha College of Physiotherapy, AHS BUILDING,SIMATS,Poonanamalee High Road, Chennai, Kuthambakkam, Tamil Nadu 600077
Chennai
TAMIL NADU 
9840545975

futurdreams88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMCH-INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  3 days a week for 8 weeks 
Intervention  Exercplay with Thoracic lymphatic pump technique  3 days a week for 8 weeks  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with mild to moderate Bronchial asthma assessed using pulmonary function test

Asthmatic children with presence of sputum

Participants will be recruited with reference to asthma diagnosis criterions of Global Initiative for Asthma including a history of variable respiratory symptoms and confirmed variable expiratory airflow limitation

Children with well-controlled asthma, with no changes in asthma medication for less than 1 month and children who use inhalers bronchodilators will be included in the study 
 
ExclusionCriteria 
Details  Children with severe and unstable asthma
Subjects with poor cognition and perception & an inability to understand instructions necessary for assessment and treatment.
Participants with other cardiopulmonary, neurological and musculoskeletal disorders.
4. Exacerbation of asthma symptoms that required the use of systemic corticosteroids in the previous 4 week or during the study period.
Children with a history of thoracic surgery.
Children with Chest and Spinal deformities
Red flag signs such as benign and malignant tumour
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Sputum eosinophil count
2. Fractional exhaled nitric oxide (FeNO)  
5 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
Six-minute walk test
Pediatric Asthma Quality of Life Questionnaire  
5 years 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   02/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/06/2025 
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 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  

Bronchial asthma (BA) is a chronic inflammatory respiratory condition characterized by bronchial hyperresponsiveness and airflow obstruction, often leading to symptoms like wheezing, shortness of breath, chest tightness, and cough. It not only affects respiratory health but can also result in reduced functional capacity, exertional dyspnea, fatigue, and activity limitations, impacting the quality of life. In children, asthma may reduce physical activity levels, with 5.5 million affected worldwide, constituting 7.5% of all children. Three key pathophysiological processes contribute to BA: bronchial inflammation, allergies, and bronchial hyperreactivity. These processes involve inflammatory cells, allergens, and excessive bronchoconstrictor responses. Current physiotherapy treatments aim to educate patients on asthma management and improve lung elasticity while addressing musculoskeletal dysfunctions. The thoracic lymphatic pump technique is a noninvasive approach for children with asthma, enhancing deep breathing and ventilation functions. Exercplay combines outdoor exercise and play to promote physical activity among children with controlled asthma. Physical fitness is associated with improved quality of life and reduced morbidity. These techniques have been used in various pulmonary conditions demonstrating promising effects on functional improvement and quality of life.

 
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