| CTRI Number |
CTRI/2025/12/099297 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Impact of Breath-Hold Technique on Inhaler Use in Obstructive Airway Diseases |
|
Scientific Title of Study
|
The Impact of Breath-Hold Technique on Inhaler Use, Pulmonary functions and quality of life among patients with Obstructive Airway Diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Accal Thomas |
| Designation |
PhD Scholar |
| Affiliation |
Vels Uniersity |
| Address |
Vels Institute of Science, Technology and Advanced Studies, Department of Physiotherapy, Allies Health Science Division, Room No.201, Pallavaram, Thalambur, Periyapalayam.
Chennai
TAMIL NADU
600117
India |
| Phone |
08156965353 |
| Fax |
|
| Email |
priyaaccalt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Senthil Selvam |
| Designation |
Professor cum HOD |
| Affiliation |
Vels Uniersity |
| Address |
Vels Institute of Science, Technology and Advanced Studies, Department of Physiotherapy, Allied Health Sciences Division, Room No. 201, Pallavaram, Thalambur, Periyapalayam.
Chennai
TAMIL NADU
600117
India |
| Phone |
944309160 |
| Fax |
|
| Email |
hodphysiotherapy@velsuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Priya Accal Thomas |
| Designation |
PhD Scholar |
| Affiliation |
Vels Uniersity |
| Address |
Vels Institute of Science, Technology and Advanced Studies, Department of Physiotherapy, Allied Health Sciences Division, Room No. 201, Pallavaram, Thalambur, Periyapalayam.
Chennai
TAMIL NADU
600117
India |
| Phone |
08156965353 |
| Fax |
|
| Email |
priyaaccalt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine and Department of Pulmonology, Govt. Medical College Kottayam, Kerala State, India |
|
|
Primary Sponsor
|
| Name |
Dr Sue Ann Zachariah |
| Address |
Department of General Medicine and Depertment of Pulmonology, Govt. Medical College Kottayam, Kerala State, 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 Priya Accal Thomas |
Government Medical College |
Department of General Medicine & Department of Pulmonary Medicine, Govt. Medical College,
Kottayam
Kerala
Kottayam
KERALA |
08156965353
priyaaccalt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Medical Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACBT Group |
Subjects given conventional treatment in OAD using ACBT technique along with the usage of inhalers. Active Cycle of Breathing Technique is a combination of 3 different breathing phases. Breath Control (BC), Thoracic Expansion Exercise (TEE) and Forced expiratory Technique (FET). Where the first phase helps you relax your airways. The second phase helps you to get air behind the mucus and third clearing the mucus. After this, the subjects are provided with information leaflets of the manufacturers for the usage of inhalers and they are asked to use their inhalers as per instructions All Within a total time of 20 minutes. |
| Intervention |
Breath Hold specific to Inhaler usage Group |
Here subjects are taught diaphragmatic breathing exercise for 10 minutes after which specific instruction for the usage of inhalers by separately educating, training and executing the breath hold technique is implemented for 10 minutes. All Within a total time of 20 minutes. |
| Intervention |
Diaphragmatic Breathing Group |
Subjects given conventional treatment in OAD using Diaphragmatic breathing technique along with the usage of inhalers. Where 05 minutes is for patient instruction and for explaining the exercises. Maintaining a relaxed position, diaphragmatic breathing exercise is performed (10 minutes). After which, subjects are provided with information leaflets for the usage of inhalers and they are asked to use their inhalers as per instructions (05 minutes). Within a total time of 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are categorised as having moderate disease severity as per GOLD classification irrespective of previous inhaler use.(FEV1 greater than 60% but less than 80% of predicted and FEV1/FVC reduced to 5% of predicted value)
|
|
| ExclusionCriteria |
| Details |
Medications that cause side effects as OAD symptoms
Patients with neurological deficits mostly concerned with sensory, motor and coordination deficits
Patients who cannot comprehend/ follow instructions for breath hold techniques.
Patients who have already been trained in any of the group specified exercise |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PFT results and SGRQ-C are tested |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
29/12/2027 |
| 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="2"
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
|
This will be an experimental study done in the outpatient and inpatient departments of general medicine and pulmonology at Government Medical College, Kottayam, for a period of 12 months after getting Scientific Review Committee and Institutional Review Board approval. All subjects who satisfy the inclusion criteria are given, informed consent and will be allowed to participate in the study. Details such as age, gender, PFT and SGRQ-C will be recorded pre-test. Subjects in the intervention group will be trained thoroughly for 6 weeks. PFT and SGRQ-C will be repeated after six weeks in all groups. Data will be entered into a proforma for data analysis.•All received a treatment of 20 minutes per day, initially supervised by the therapist for 4 days in the first week. For the next 2-6 weeks, they were telephonically followed up on for a total of 6 weeks. |