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CTRI Number  CTRI/2025/07/092057 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Study to Assess How a 6-Week Pulmonary Rehabilitation Program Affects Walking Ability in Patients with Chronic Obstructive Pulmonary Disease 
Scientific Title of Study   Effect of 6-week Pulmonary Rehabilitation Program on spatial gait variables in chronic obstructive pulmonary disease 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. Mayuri Shah  
Designation  Associate Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  310,Cardio-Respiratory Department Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018
Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India 
Phone  8087861628  
Fax    
Email  mayuri.shah@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mayuri Shah  
Designation  Associate Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  310,Cardio-Respiratory Department Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018
Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India 
Phone  8087861628  
Fax    
Email  mayuri.shah@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Prerna Chandekar 
Designation  Postgraduate Student 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Cardio-Respiratory Department Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018
Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India 
Phone  9834085084  
Fax    
Email  prernachan23@gmail.com   
 
Source of Monetary or Material Support  
Dr. D.Y.Patil College of Physiotherapy, Pune-411018 Maharashtra, India 
 
Primary Sponsor  
Name  Prerna Chandekar 
Address  310,Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018 
Type of Sponsor  Other [self] 
 
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 Mayuri Shah   Dr. D.Y. Patil College of Physiotherapy  310, Cardio-Respiratory Department Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA 		 8087861628

mayuri.shah@dpu.edu.in 
 
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: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group- Home-Based Rehabilitation   After IEC approval, X COPD patients will be recruited. Pre- and post-assessments include vitals and gait analysis using the Ochy app. Participants will be randomized into: Control Group – 6-week home-based rehab with similar exercises at lower intensity. Data will be recorded and securely stored. 
Intervention  Experimental Group- Tailored 6-week Pulmonary Rehabilitation   After IEC approval, X COPD patients will be recruited. Pre- and post-assessments include vitals and gait analysis using the Ochy app. Participants will be randomized into: Experimental Group – 6-week supervised pulmonary rehab (aerobic, strength, balance, breathing exercises). Data will be recorded and securely stored. 
 
Inclusion Criteria  
Age From  40.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. COPD patients stage mild to moderate based on GOLD criteria FEV1 between 50% -80%
2. Middle-aged (40-60) years
3. Dyspnea grade 1-2 on MMRC scale
 
 
ExclusionCriteria 
Details  1.Presence of neurological disorders like stroke, spinal cord injury, peripheral nerve injury
2.Musculoskeletal injuries like soft tissue injuries, recent fractures, any deformities of spine or lower extremity
3.Unmanaged cardiovascular conditions like recent MI, unstable angina
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.Spatial Gait Parameters:
•Stride Length
•Step Length

 		 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Quality of life:
•GOLD criteria for severity of airflow obstruction
•Modified Medical Research Council (MMRC) Dyspnea Scale
•Spirometry Test

2.Patient Feedback
•Surveys assessing participant satisfaction with the pulmonary rehabilitation program
 		 6-weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 progressive respiratory disorder that impairs physical activity and often alters gait due to reduced oxygen availability and muscle deconditioning. Research indicates that COPD patients commonly exhibit shorter stride and step lengths, which may increase fall risk and lower quality of life. This study aims to assess the impact of a 6-week pulmonary rehabilitation program on spatial gait parameters—specifically stride length and step length—in COPD patients using the Ochy app. An experimental study will be conducted at Dr. D.Y. Patil College of Physiotherapy, Pune, involving 60 middle-aged COPD patients selected through convenient sampling. Participants will be assessed pre- and post-intervention using video-based gait analysis via the Ochy app. The experimental group will undergo a supervised pulmonary rehabilitation program, while the control group will follow a home-based exercise routine. The study seeks to provide insights into how rehabilitation may improve gait and mobility in individuals with COPD. 
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