| 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
|
|
|
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
|
|
|
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. |