| CTRI Number |
CTRI/2024/06/068862 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Breathing exercises ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients with breathing difficulty diagnosed as COPD who are on inhaler therapy, Breathing exercises and proper inhaler training will be given and the outcome will be measured using
quality of life questionnaires and breathlessness scores in improving the quality of life in a government hospital |
|
Scientific Title of Study
|
The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnoea and life quality in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayapriya.N |
| Designation |
Post graduate |
| Affiliation |
Institute of thoracic medicine, Madras medical College |
| Address |
Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu,India.
Chennai
TAMIL NADU
600003
India |
| Phone |
9791736590 |
| Fax |
|
| Email |
priyapieriss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.A.Sundararajaperumal |
| Designation |
PROFESSOR |
| Affiliation |
Institute of Thoracic Medicine, Madras medical College,RGGGH,Chennai-600003 |
| Address |
Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu,India.
Chennai
TAMIL NADU
600003
India |
| Phone |
04428361433 |
| Fax |
|
| Email |
drsrperumal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Jayapriya |
| Designation |
Post graduate - Principal Investigator |
| Affiliation |
Institute of thoracic medicine,Madras medical College |
| Address |
Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu,India.
Chennai
TAMIL NADU
600003
India |
| Phone |
9791736590 |
| Fax |
|
| Email |
priyapieriss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi government general hospital |
| Address |
Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu,India. |
| Type of Sponsor |
Government medical college |
|
|
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 Jayapriya |
Rajiv Gandhi Government General Hospital,Chennai |
Room no 106,
New Respiratory Block,
Institute of Thoracic Medicine,
Rajiv Gandhi Government General Hospital,
Madras Medical College,
Chennai 600003,
Tamilnadu, India.
Chennai
TAMIL NADU |
9791736590
priyapieriss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing exercises |
Chronic Obstructive Pulmonary Disease( COPD) patients who meet the inclusion criteria will be selected.After basic data collection COPD patients randomly Assigned into treatment group and control group.Both the groups will be assessed using COPD assessment score(CAT), mMRC(Modified Medical research council) dyspnea scale and SGRQ(St Georges Respiratory Questionnaire), then treatment group will be given Pursed lip breathing training, Diaphragmatic breathing training and Yogic breathing exercise (Pranayama) training for 3 times weekly for 4 weeks with each session for minimum of 30 minutes along with Proper inhaler training (standard of care) and patients will be continuing these breathing exercises(intervention) at home twice daily and are encouraged to maintain a record of their activities, which will be verified during follow up visit.After 4 weeks Secondary assessment for improvement of quality of life and improvement in dyspnea will be done using COPD assessment score(CAT), mMRC(Modified Medical research council) dyspnea scale and SGRQ(St Georges Respiratory Questionnaire), then Comparison of improvements before and after intervention between treatment and control group. |
| Comparator Agent |
No breathing exercises
|
Control group will be given only proper inhaler training(standard of care) without breathing exercises.
Secondary
assessment using
COPD assessment score(CAT), mMRC(Modified Medical research council) dyspnea scale and SGRQ(St Georges Respiratory Questionnaire)will be done. Then
comparison of
improvements in quality of life and improvement in dyspnea before and after
intervention between treatment
and control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with COPD from 18 years to 70 years, using inhalers and those have not previously taken breathing exercise training |
|
| ExclusionCriteria |
| Details |
Persons with mental disorder and communication disabilities, heart disease that could lead to dyspnoea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dyspnea grade assessed using MMRC(Modified medical research council) scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life will be assessed using St George respiratory questionnaire (SGRQ) and COPD assessment test(CAT) score |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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="1"
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
|
Myself Dr.Jayapriya, pursuing my post graduation at Madras medical College, Chennai would like to do my thesis on the topic " The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnoea and quality of life in a tertiary care centre".This is a randomized controlled trial, where the Standard of care(Inhaler training) will be given to both the study arms. Apart from standard of care, one arm will receive Breathing exercise training. Rest of the care (pharmacological) will be similar between the two arms. The efficacy will be assessed using estimated change in mMRC grade between the arms (receiving Breathing exercise training versus those not receiving Breathing exercise training). Breathing exercise training is a non-pharmacological intervention, where patients will be trained with different breathing techniques with proven benefits in COPD patients. There will be no additional harm to patients receiving this additional training. |