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CTRI Number  CTRI/2025/03/083232 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
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   Proprioceptive Neuromuscular Facilitation techniques along with aerobic training and breathing exercises in improving functional capacity on COPD patients  
Scientific Title of Study   Additive effect of proprioceptive neuromuscular facilitation stretching along with aerobic training and breathing exercise on functional capacity 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  Sakshi Khobragade 
Designation  Post Graduate Student 
Affiliation  Datta Meghe college Of Physiotherapy Wanadongri Hingna 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  8381029906  
Fax    
Email  sakshikhobragade7385@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sachin Annaji Chaudhary 
Designation  Principal and Professor 
Affiliation  Datta Meghe college Of Physiotherapy Wanadongri Hingna 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  9960898805  
Fax    
Email  drsachin1982@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sakshi Khobragade 
Designation  Post Graduate Student 
Affiliation  Datta Meghe college Of Physiotherapy Wanadongri Hingna 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road, Nagpur 441110 MAHARASHTRA India

Nagpur
MAHARASHTRA
441110
India 
Phone  8381029906  
Fax    
Email  sakshikhobragade7385@gmail.com  
 
Source of Monetary or Material Support  
Shalinitai Meghe Hospital and research center Wanadongri Hingna Nagpur 441110 MAHARASHTRA India  
 
Primary Sponsor  
Name  Datta Meghe College Of Physiotherapy  
Address  wanadongri Hingna Road Nagpur 441110 MAHARASHTRA India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Khobragade  Shalinitai Meghe Hospital and research center  Ward No. 15 Division A Respiratory ward
Nagpur
MAHARASHTRA 
8381029906

sakshikhobragade7385@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges , Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Aerobic training and purse lip breathing Exercise  Pursed Lip breathing: Repetition 10 repetitions Sets 3 times Pursed lip breathing is a breathing technique that can help with shortness of breath and other breathing difficulties. Aerobic exercise:Stair climbing Duration 20-30 minutes Sets 3 times Stair climbing is a practical and effective aerobic exercise for patients with Chronic Obstructive Pulmonary Disease (COPD  
Intervention  Proprioceptive Neuromuscular Facilitation   PNF Muscles: Scalenus,SCM, Trapezius, pectoralis major & minor,intercostal, Serratus ant.,Rectus abdominis Duration 30 min/day Sets 3 times per session 5 days per week for 4 weeks Chest Proprioceptive Neuromuscular Facilitation (PNF) in COPD patients aims to enhance respiratory efficiency, reduce dyspnea, and improve chest wall mobility. The technique targets specific respiratory muscles which often become tight or weak in COPD due to chronic hyperinflation of the lungs.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Mild to Severe COPD criteria of Global initiative for COPD disease GOLD 1 and 3
2 Ratio of Forced expiratory volume in first second and forced vital capacity FEV1/ FVC less than zero point 7 and 30 percent less than or equal to 30 percentFEV1 percent less than 80 percent
3 vitally unstable Patients
 
 
ExclusionCriteria 
Details  1 Serious conditions which require auxiliary supply of oxygen or ventilatory support devices
2 Inability to follow the pulmonary rehabilitation program
3 Cognitive disorders with definite medical history
4 Severe complications 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Pulmonary Function Test
forced expiratory volume in one second(FEV1)
2 forced vital capacity(FVC)
3 FEV1/FVC 
pre intervention and after 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
walk distance in meters
 
pre intervention and after 4 weeks of intervention 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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)   05/04/2025 
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="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  

Chronic obstructive pulmonary disease (COPD) is a condition which is caused by constant 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. COPD patients will have a hyperinflated chest, which shortens their muscles and decreases the suppleness of their chest wall, increasing the effort required to breathe. As the severity grows, using the upper limbs for functional tasks becomes more challenging, which will again cause stiffness and tightness in the muscles. Some techniques are externally applied proprioceptive and tactile stimuli that produce reflex respiratory movement responses that appear to alter the rate and depth of breathing. Proprioceptive Neuromuscular Facilitation (PNF) is a facilitative technique designed to enhance chest wall mobility, thereby promoting improved chest expansion. PNF stretching focuses mostly on the musculoskeletal system, it may also improve posture and thoracic mobility, which may have an indirect effect on respiratory function. Breathing mechanics can be optimized with improved posture. To improve passive range of motion and lengthen out tense muscles, apply the hold - relax technique.

Participants will meet the inclusion criteria will be briefed about the study and written consent will be taken. Demographic data will be documented .E ach participant will be pre - assessed with  6MWT and PFTs (FVC, FEV1 and FEV1/FVC).6MWT and PFTs (FVC, FEV1 and FEV1/FVC) evaluated pre and post intervention. participants were given Pursed lip breathing+ aerobic training (Stair climbing - 10reps ,3sets) with PNF stretching Muscles: scalenus, STM, Trapezius, pectoralis major & minor ,intercostal, ant. Serratus, Rectus abdominis HOLD RELAX METHOD 30 min/day+ 10 min , 3 times per session (5 days per week for 4 weeks).

 
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