| CTRI Number |
CTRI/2024/07/071596 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
What is the effect of breathing exercise on balance and stability among college students with irregular breathing rhythm. |
|
Scientific Title of Study
|
Immediate effect of breathing retraining on balance and stability in collegiates with altered breathing pattern |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puviyarasi S |
| Designation |
PG student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
PT33, 4th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176225571 |
| Fax |
|
| Email |
ps8688@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anandhi. D |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no. PT05, 5th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Puviyarasi S |
| Designation |
PG student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no. PT33, 4th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176225571 |
| Fax |
|
| Email |
ps8688@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no. PT37, 3rd floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India. 603203 |
|
|
Primary Sponsor
|
| Name |
PUVIYARASI S |
| Address |
Room no. PT 33, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India. 603203 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| PUVIYARASI S |
SRM Institute of Science and Technology |
Room no. PT 37, 3rd floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Kancheepuram, TamilNadu, India, 603203.
Kancheepuram
TAMIL NADU |
9176225571
ps8688@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Thoracoabdominal breathing individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic breathing exercises |
subjects in experimental group (89 subjects) will alone be trained to do diaphragmatic breathing exercise in semi fowlers position, where they will be instructed to breath in slowly and deeply through nose concentrating the abdomen to rise first and breath out slowly through mouth for 5 reps, 3 sets. |
| Comparator Agent |
Without diaphragmatic breathing exercises |
Subjects in control group (89 subjects) will not receive diaphragmatic breathing exercise. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with thoracoabdominal breathing is assessed with Hi- Lo test.
Subjects with chest expansion symmetrical. |
|
| ExclusionCriteria |
| Details |
Subjects with respiratory problems.
Subjects with vertigo.
Subjects with neuromuscular disease.
Subjects with chest wall deformity.
Subjects with recent fractures in thorax, pelvis and lower extremity.
Those who are not agreed to participate. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hi- lo test |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Balance and weight distribution from
Unipedal stance
Bipedal stance
Tandem stance
Stabilometry will be obtained from plantar pressure system mobile mat. |
Before and after intervention |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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)
|
10/08/2024 |
| 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="0"
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
|
Subjects will be selected based on the inclusion and exclusion criteria and the purpose of the study will be clearly explained to the subject. From the subject informed consent will be collected. Subjects with thoraco abdominal breathing will be selected by performing Hi- Lo test where the subject will be asked to sit on the chair and the therapist in standing or kneeling in front and slightly to the side of the subject. The therapist places one hand on the subject’s sternum and one hand on their upper abdomen to check whether thoracic or abdominal motion is dominant during breathing. After selection, the subjects will be divided into two groups (group 1 experimental group- 89 subjects and group 2 control group- 89 subjects) and the individuals of both the groups will be made to stand on the plantar pressure mobile mat for Pre- assessing the balance and weight distribution by performing unipedal, bipedal, tandem stance and stabilometry. Once the pre- assessment is completed, the subjects in experimental group (89 subjects) will alone be trained to do diaphragmatic breathing exercise in semi fowlers position, where they will be instructed to breath in slowly and deeply through nose concentrating the abdomen to rise first and breath out slowly through mouth for 5 reps, 3 sets. After 20 minutes, post- assessment for balance and weight distribution will be taken for both the group by making the subjects to stand individually again in the plantar pressure system mobile mat and asked to perform unipedal, bipedal, tandem stance and stabilometry. The pre and post values of balance and weight distribution from unipedal, bipedal, tandem stance and stabilometry will be calculated from the EZRA SOFTWARE connected in the laptop. By comparing the pre and post assessment the immediate effect of breathing retraining on balance and stability will be calculated for the subjects with altered breathing pattern. |