| CTRI Number |
CTRI/2026/02/103106 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two breathing exercises in people with mild to moderate COPD |
|
Scientific Title of Study
|
Comparison of Diaphragmatic Stretch Technique vs Proprioceptive Neuromuscular Facilitation Technique for Mild to Moderate 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 |
Hasini Ramesh |
| Designation |
BPT student |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9448204969 |
| Fax |
|
| Email |
hasiniramesh04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hasini Ramesh |
| Designation |
BPT student |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9448204969 |
| Fax |
|
| Email |
hasiniramesh04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Jain N |
| Designation |
Associate professor |
| Affiliation |
Narayana Hrudayalaya Foundations |
| Address |
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra Industrial Area, Anekal Taluk, Bangalore- 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9731036332 |
| Fax |
|
| Email |
ndjk2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| 258/A, Health city,Mazumdar Shaw Hospital, Bommasandra Industrial Area, Anekal Taluk, Bangalore, Karnataka, India- 560099
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health and Sciences (RGUHS) |
| Address |
4th T Block Jayanagar Bangalore 560041 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrHasini Ramesh |
Mazumdar Shaw Medical Center |
258/A, Bommasandra Industrial Area, Department of Cardio Respiratory Rehabilitation, OPD, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA |
09448204969
hasiniramesh04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
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 |
Comparison of Diaphragmatic Stretch Technique vs. Proprioceptive Neuromuscular Facilitation Technique for Mild to Moderate COPD Patients. |
Group 1: After Random allocation of patients are instructed to sit upright. The therapist should stand facing the back of the subject. The therapist should place his/her hands over the rib cage, placing the fingers deep inside the subcostal margin. A gentle, but firm traction is to be maintained while the patient inhales. Stretch is applied in two repetitions of ten breaths with rest for 1 min.
Group 2: After Random allocation of patients PNF of Respiration techniques to stimulate diaphragm muscle Pressure and stretch is applied with the thumbs pushed up under the rib cage. Emphasize with sustained pressure to the other side. Resistance applied to forced expiration in this area by resisting the downward motion of ribcage to prevent the diameter of the lower chest as exhales. |
| Comparator Agent |
Diaphragmatic Stretch Technique and Proprioceptive Neuromuscular Facilitation |
After Random allocation of patients are instructed to sit upright. The therapist should stand facing the back of the subject. The therapist should place his/her hands over the rib cage, placing the fingers deep inside the subcostal margin. A gentle, but firm traction is to be maintained while the patient inhales. Stretch is applied in two repetitions of ten breaths with rest for 1 min.
|
| Comparator Agent |
Proprioceptive Neuromuscular Facilitation Technique for Mild to Moderate COPD Patients. |
After Random allocation of patients PNF of Respiration techniques to stimulate diaphragm muscle Pressure and stretch is applied with the thumbs pushed up under the rib cage. Emphasize with sustained pressure to the other side. Resistance applied to forced expiration in this area by resisting the downward motion of ribcage to prevent the diameter of the lower chest as exhales
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having complaint of breathlessness, cough and sputum production ,and reduced chest expansion.
Stable COPD patients of both genders classified according to GOLD 2016 criteria.
Mild COPD defined as FEV1 sixty percent to eighty percent predicted.
Moderate COPD defined as FEV1 fifty percent to sixty percent predicted.
Patients less than 40 years old, BMI 18to 36kg m.
Patients with stable clinical condition without any changes of dosage and medications in 1 month
|
|
| ExclusionCriteria |
| Details |
Patient having with unstable haemodynamic parameters, neuromuscular or restrictive disease pathology.
Patient having with Tuberculosis, Pneumonia or any infections associated with lungs.
Patients with Respiratory impairment or injury to the phrenic nerve, Diaphragmatic weakness.
Patients with Acute onset Exacerbation of COPD.
Patients not willing to cooperate duration of the study - 3 months.
Patients with recent history of Cardiothoracic or Abdominal surgery.
Patients with any chest wall/ abdominal trauma or chest wall deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Borg scale |
Baseline (Day 0),
Post-intervention (Week 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breathlessness |
Baseline (Day 0),
Post-intervention (Week 4) |
| Chest expansion |
Baseline (Day 0),
Post-intervention (Week 4) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/02/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
COPD is a
condition that is characterized by air flow limitation that is not fully
reversible which is caused by pulmonary symptoms and airway obstruction that is
due to inflammation of the airways, chronic in nature, and damage to parenchyma
of lung which leads to anatomical variations and collapse in alveoli. The
airflow limitation is usually both progressive and associated with abnormal
inflammatory response of the lungs to noxious particles or gases.
Proprioceptive Neuromuscular Facilitation Technique
is effective in improving the Respiratory function, increasing chest and
shoulder mobility, and enhancing exercise capacity. Diaphragmatic
Stretch Technique can improve breathing efficiency; improve chest wall
mobility, and diaphragmatic mobility. |