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CTRI Number  CTRI/2025/07/089939 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Immediate Benefits of Chest Exercises PNF among Patients With Respiratory Disease COPD 
Scientific Title of Study   Immediate Effect of Chest Proprioceptive Neuromuscular Facilitation among Patients With Chronic Obstructive Pulmonary Disease 
Trial Acronym  FIST-PNF-COPD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minaxi PT PhD 
Designation  Assistant Professor 
Affiliation  Saket college of physiotherapy  
Address  Room no. 66, Saket College of Physiotherapy, Chandimandir ,Panchkula, Haryana, 134107, India

Panchkula
HARYANA
134107
India 
Phone  9041095121  
Fax    
Email  xs4minaxi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minaxi PT PhD 
Designation  Assistant Professor 
Affiliation  Saket college of physiotherapy  
Address  Room no. 66, Saket College of Physiotherapy, Chandimandir ,Panchkula, Haryana 134107 India

Panchkula
HARYANA
134107
India 
Phone  9041095121  
Fax    
Email  xs4minaxi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gagan 
Designation  Student (Masters of Physiotherapy) 
Affiliation  Saket college of physiotherapy  
Address  Room. no 55 ,College rehabiliation centre, Saket College of Physiotherapy, Chandimandir ,Panchkula, Haryana, 134107, India
Saket college of physiotherapy, Chandimandir ,Panchkula, Haryana
Panchkula
HARYANA
134107
India 
Phone  7901753688  
Fax    
Email  gaganmg21@gmail.com  
 
Source of Monetary or Material Support  
I Gagan will myself bear the cost of the study, saket college of physiotherapy chandimandir, panchkula Haryana 134107 India 
 
Primary Sponsor  
Name  Saket college of physiotherapy  
Address  Saket college of physiotherapy, Chandimandir, Panchkula, Haryana,134107,India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Civil Hospital  Sector 06, Panchkula, Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gagan  Saket College of physiotherapy  Room. no 55 ,College rehabiliation centre, Saket College of Physiotherapy, Chandimandir ,Panchkula, Haryana, 134107, India
Panchkula
HARYANA 		 7901753688

gaganmg21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Segmental breathing with pursed lip breathing  Segmental breathing with pursed lip breathing in control group will applied in such a way that 10 repetition of 2-3 sets in control group.  
Intervention  Intercostal stretch   Treatment protocol Experimental group receiving intercostal stretch with pursed lip breathing will applied in such a way that In total 1 minute, we considered 10 breath cycle in 1 minute. So, after every 3 sequential breath 1 intercostal stretch will be applied in expiratory phase and maintained it till the end of inspiratory phase. In 10 breath cycle total 3 stretches will be given. We will going to perform 3 sets in each 1 minute, 3 intercostal stretches applied that is followed by 1 minutes of relaxation after each set/cycle. On the completion of 3 set/cycle of intercostal stretch followed by 2 minute of breath control intercostal stretch will be given in downward direction during expiratory phase, air expires out of lungs with pursed lip breath and it will be maintained till next inspiratory phase till 1 complete cycle of breath. After applying Chest PNF technique with pursed lip breathing post intervention values of dyspnoea, chest expansion desired haemodynamic functions like blood pressure, heart rate, SpO2 values will be measured. Total duration will be 20-25 minutes 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Diagnosed COPD patients as per GOLD classification 
 
ExclusionCriteria 
Details  Uncooperative or unwilling patient should be excluded
Severe and very severe stage of COPD whose FEV is less than and equals to 30 percent and not more than 50 percent
Chest trauma, Ribs fracture, Thoracic vertebral fracture
Cardiac and abdominal surgery  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Dyspnoea(Modified berg scale)
Chest Expansion(Measuring Tape)
 		 Pre-intervention and immediately
Post-intervention (same day)
 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic functions
Blood pressure (Mercury sphygmomanometer,
Digital sphygmomanometer)
Heart rate(Pulsed oximeter)
SPO2(Pulsed oximeter) 		 Pre-intervention & immediately Post-intervention (same day)
 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   15/07/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gaganmg21@gmail.com].

  6. For how long will this data be available start date provided 20-09-2026 and end date provided 20-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Chronic Obstructive Pulmonary Disease COPD is a chronic condition characterized by inflammation and abnormal lung changes. Chest Proprioceptive Neuromuscular Facilitation PNF is widely used intervention in cardiopulmonary physiotherapy for pulmonary rehabilitation. Intercostal stretch is one of the PNF technique used to increase chest wall mobility and promote proper lung ventilation and gas exchange. Previous researches focused on the immediate effect of chest PNF on pulmonary functions, not on haemodynamic function. Moreover, these studies did not contain well defined protocols. Furthermore, the literature is also limited for the effect of single session of chest PNF among patients with COPD. These studies have not included patients with just after the relief of COPD exacerbations. Therefore, the proposed study fills that gap and provides a more comprehensive understanding of how PNF interventions can improve both pulmonary and cardiovascular health in COPD patients. This study aims to provide a more comprehensive understanding of how PNF interventions can improve pulmonary and cardiovascular health. This present study will be single session experimental study (Pre - test Post-test with control group design). The sample size of this study will be calculated on the basis of previous studies. Sample size for single group(n) is 35. The intervention will be applied for 20-25 minutes in 3 sets. The intervention will be perform intercostal stretch followed by pursed lip breathing in experimental group and segmental breathing with pursed lip breathing in control group and pre and post outcomes measures will be dyspnoea, chest expansion desired haemodynamic functions like blood pressure, heart rate, SpO2. The present study will generate evidence regarding the beneficial effect of single session of chest PNF. These findings can be implemented in the intensive care setting and cardiopulmonary rehabilitation in COPD patients to improve their recovery outcome. 
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