| CTRI Number |
CTRI/2025/08/092136 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| 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
|
Effects of a Breathing Exercise Protocol Combined with Stretching of Respiratory Muscles on Functional Capacity and Quality of Life in COPD Patients. |
|
Scientific Title of Study
|
Effect of Structured Breathing Exercise Protocol along with Proprioceptive Neuromuscular Facilitation Stretching on functional capacity, Peak expiratory flow rate and HR-QoL in COPD patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhruvi Satra |
| Designation |
Postgraduate Student |
| Affiliation |
Dr. APJ Abdul Kalam COPT, Pravara Institute of Medical Sciences, Loni, Maharashtra, India |
| Address |
Cardio-respiratory physiotherapy department Dr APJAK College of Physiotherapy Pravara Institute of Medical Sciences DU Loni Maharashtra India 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8806224822 |
| Fax |
|
| Email |
dhruvisatra01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhur Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. APJAK COPT PIMS DU |
| Address |
Cardio-respiratory physiotherapy Department, Dr. APJAK COPT, Pravara Institute of Medical Sciences, Loni.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7588009063 |
| Fax |
|
| Email |
madhurkulkarni19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhur Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. APJAK COPT PIMS DU |
| Address |
Cardio-respiratory physiotherapy Department, Dr. APJAK COPT, Pravara Institute of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7588009063 |
| Fax |
|
| Email |
madhurkulkarni19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardio-respiratory physiotherapy Department Dr APJAK COPT PIMS Loni Maharashtra India 413736 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Non funded] |
|
|
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 DHRUVI SATRA |
Dr APJAK COPT |
Cardio-respiratory physiotherapy department PIMS Loni Tal Rahta District Ahmadnagar Maharashtra India 413736
Ahmadnagar
MAHARASHTRA |
08806224822
dhruvisatra01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. APJAK COPT PIMS DU |
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 |
| Comparator Agent |
PNF Stretching |
PNF Stretching:
Stretching was applied to the scalenus, sternocleidomastoid, trapezius muscle, pectoralis major, intercostal muscles, and serratus anterior muscle for 15 minutes altogether. The specific method was the hold-relax method of PNF stretching. The therapist first stretched the muscles to the maximum length the patient could tolerate. The muscles had 3 seconds of isometric contraction against resistance and then relaxed. The therapist then applied 15 seconds of stretching on the muscles. All the muscles were stretched in turn. This procedure was repeated three times.
|
| Intervention |
Structured Breathing Exercise Protocol |
4-7-8 breathing technique – 5 reps and 2 sets
Energy conservation and work simplification techniques
Diaphragmatic weight training – 5 reps and 3 sets
Box breathing technique 5 reps and 2 sets
Active Cycle of Breathing Technique – 5 cycles
Pursed lip breathing – 5 reps and 5 sets
Paper blowing exercise – 5 reps and 2 sets
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants included will be
1. Participants with moderate to severe COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease GOLD
GOLD 2 Moderate using a peak flow meter with 150 to 249 l/min PEFR.
GOLD 3 Severe using a peak flow meter with 100 to 149 l/min PEFR.
2. 30 to 60 years old patients with COPD.
3. Both males and females.
4. Ability to provide written informed consent and willingness to participate in the full duration of the study.
|
|
| ExclusionCriteria |
| Details |
Participants excluded will be
1) Serious conditions that require ventilatory support
2) Any neurological condition where the patient is unable to follow the therapists commands
3) Cognitive disorders with a definite medical history
4) With Severe complications like Cor Pulmonale Atelectasis etc.
5) Patients who had recently undergone major surgeries like abdominal cardio-thoracic or gynecological surgery
6) Patients with musculoskeletal disorders like clavicle scapula humerus sternum or ribs fracture flail chest or shoulder dislocation
7) Open wounds at or near chest
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
CAT COPD Assessment of QoL Questionnaire
PEFR
6 min walk test
|
At baseline and after 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
11/08/2025 |
| 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="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
|
All the participants referred from the IPD medicine department for physiotherapy will be screened based on the inclusion and exclusion criteria. Participants will be briefed about the nature of the study and the effect of the intervention in the language best understood by them and the treatment will be demonstrated to them. Written informed consent will be obtained and they will be divided into 2 groups groups A and B, by using numbered sealed opaque envelopes. Group A The control group will receive the Structured Breathing Exercise Protocol. Group B The experimental group will receive Structured Breathing Exercise Protocol along with PNF Stretching for accessory respiratory muscles. All the participants will be assessed for functional capacity using the 6 min walk test, for peak expiratory flow rate (PEFR) using the peak flow meter and for Quality of Life (QoL) with the CAT COPD Assessment Questionnaire. The measurements will be done on the 1st and the last day of the 2-week intervention program to give values pre and post training for each participant. The intervention duration for Group A will be one session a day for 30 minutes for 2 weeks (6 days a week) and Group B will be one session a day for 45 minutes for 2 weeks (6 days a week). Comparison between both the findings will be done and the conclusion will be made. |