| 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
|
|
|
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
|
|
|
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). |