| CTRI Number |
CTRI/2025/07/091930 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving Breathing in Asthma Patients Through Core Strengthening Exercises |
|
Scientific Title of Study
|
EFFECT OF CORE STRENGTHENING EXERCISE IN REDUCING DYSPNEA IN PATIENTS WITH MODERATE PERSISTENT 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 |
S Visali |
| Designation |
Student ( Master of physiotherapy) |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
No:395,Sri Ramakrishna institute of paramedical sciences, Sarojini Naidu road, sidhapudur, coimbatore 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9385731915 |
| Fax |
|
| Email |
visalisivasankaran28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R. Amutha |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
sri Ramakrishna institute of paramedical sciences 395,sarojini naidu road, siddhapudur, coimbatore
641044
395 sarojini naidu road, siddhapudur, coimbatore
641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9843255234 |
| Fax |
|
| Email |
ramuthakk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Visali |
| Designation |
Student ( Master of physiotherapy) |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences |
| Address |
Third floor,395 , Sri Ramakrishna institute of paramedical sciences sarojini naidu road, siddhapudur, coimbatore
641044
Third floor 395 sri Ramakrishna institute of paramedical sciences sarojini naidu road, siddhapudur, coimbatore
641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9385731915 |
| Fax |
|
| Email |
visalisivasankaran28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S.Visali |
| Address |
395, sarojini naidu road siddhapudur coimbatore
641044 |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
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 |
| SVisali |
Sri Ramakrishna multi-speciality hospital |
First floor department of pulmonology 395, Sarojini Naidu road siddhapudur coimbatore
641044
Coimbatore
TAMIL NADU |
9385731915
visalisivasankaran28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna hospital |
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 |
| Intervention |
core strengthening exercise along with diaphragmatic breathing exercise |
Abdominal bracing weight bearing exercise
Abdominal bracing non weight bearing
Side support exercises
Quadruped exercises |
| Comparator Agent |
Diaphragmatic breathing exercise |
Place one hand on the chest and the other on the abdomen
Instruct the patient to inhale slowly through the nose aiming to expand the abdomen
Ask the patient to hold the breath for 1–2 seconds optional
Exhale slowly through pursed lips while gently contracting the abdominal muscles
The hand on the chest should remain still the hand on the abdomen should rise and fall with each breath. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age group 35 to 45 years old
BMI less than 30
Gender - female
patients with moderate persistent asthma based on severity of disease NATIONAL
ASTHMA EDUCATION AND PREVENTION PROGRAM Guidelines
Modified borg scale- Moderate 4 to very severe.
SPO2 more than or equal to 92 % at rest breathing
core endurance test partial situp less than 35 seconds, bilateral supine SLR less than 18 seconds, prone chest raise less than 63 seconds, bilateral prone SLR less than 45 seconds |
|
| ExclusionCriteria |
| Details |
Clinically Unstable patients
Who had significant neuromuscular musculoskeletal disorder
pneumothorax
Patient with cardiac disease
Not willing to participate in the study.
Hypertension.
Major spinal surgery
chronic lung pathology other than asthma |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test FEV1 |
Baseline data at first week and post data at 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Borg Dyspnea Scale |
Baseline at 1st week & post data at 8 th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/07/2025 |
| 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
|
Patients of moderate persistent asthma are taken from Sri Ramakrishna hospital, Department of Pulmonology. These patients are assigned according to the inclusion and exclusion criteria. 30 Patients are divided into two groups according to their availability and conveniently allocated. The pretest measures are taken by Modified Borg dyspnea scale, and Pulmonary function test fev1 A well explained consent form is given and approval of patients are received Group A will receive core strengthening exercise along with Diaphragmatic breathing exercise Group B will receive diaphragmatic breathing exercise Group A received the treatment for 35 mins per day for 3 days a week for consecutive 8 week with 2 seconds rest period between each repetition and 5 mins rest period between each exercise. The post- test values are measured. The values are taken and tabulated and all the values are applied in statistical formula and all analysis is done and checked Finally based on the results of statistical analysis, conclusion regarding the intervention is made. |