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CTRI Number  CTRI/2025/08/092389 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Supervised Pulmonary Tele-rehabilitation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare Supervised Pulmonary Tele-rehabilitation and Standard Care in Patients with Chronic Obstructive Pulmonary Disease, at a Delhi Hospital. 
Scientific Title of Study   Effectiveness of Adjunct Supervised Pulmonary Tele-rehabilitation as Compared to Standard Treatment in the Management of Chronic Obstructive Pulmonary Disease at a Tertiary Care Hospital in Delhi: A Randomised Controlled Trial 
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 Shubhadeep Maiti 
Designation  First year Postgraduate Resident  
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital  
Address  First year Postgraduate Resident Department of Community Medicine University College of Medical Sciences and Guru Teg Bahadur hospital Dilshad Garden Delhi 110095

North East
DELHI
110095
India 
Phone  9051017050  
Fax    
Email  shubhadeepm@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhu Kumari Upadhyay  
Designation  Director Professor 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital  
Address  Dr Madhu Kumari Upadhyay Director Professor Room No 404 College Building Department of Community Medicine University College of Medical Sciences & Guru Teg Bahadur Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9871423042  
Fax    
Email  mu3071@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhu Kumari Upadhyay  
Designation  Director Professor 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital  
Address  Dr Madhu Kumari Upadhyay Director Professor Room No 404 College Building Department of Community Medicine University College of Medical Sciences & Guru Teg Bahadur Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9871423042  
Fax    
Email  mu3071@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences and Guru Teg Bahadur Hospital Dilshad Garden Delhi-110095 India 
 
Primary Sponsor  
Name  Shubhadeep Maiti 
Address  First Year Postgraduate Resident Department of Community Medicine University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi-110095 
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 
Shubhadeep Maiti  University College of Medical Sciences and Guru Teg Bahadur Hospital  Catchment area of Guru Teg Bahadur Hospital, a tertiary care hospital in Delhi. Recruitment of participants would be done from OPD of Department of Respiratory Medicine, Guru Teg Bahadur Hospital, Dilshad Garden Delhi 110095.
North East
DELHI 		 9051017050

shubhadeepm@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI - 110095  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  Standard Treatment in the Management of Chronic Obstructive Pulmonary Disease   Participants in the control group will receive standard treatment, without Pulmonary Tele-rehabilitation (PTR), immediately following their diagnosis in the outpatient department (OPD).  
Intervention  Supervised Pulmonary Tele-Rehabilitation in adjunct to Standard treatment in the Management of Chronic Obstructive Pulmonary Disease.  The intervention group will receive an initial in-person pulmonary rehabilitation (PR) session conducted by the investigator with the help of a physiotherapist specifically trained in PR in addition to the standard treatment and an educational e-booklet and instructional videos in Hindi language. Educational sessions as a part of PR covering key topics such as COPD management, benefits of PTR, lifestyle modification, nutrition, smoking cessation, inhalation techniques, and information with regard to recognition of early signs of exacerbation would also be provided to them. Participants will then undergo remotely supervised PTR sessions (50–60 minutes) via a web-based video conferencing platform, three times per week for the next 12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Age 18 years or older and consenting to participate in the study.
2.Clinical diagnosis of COPD by pulmonary function test (PFT):
I.Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70,
II.Forced Expiratory Volume in 1 second less than 50 percent
III. Modified Medical Research Council (mMRC) dyspnoea score ranging from 2 to 4.
3.Participants having access to and able to use smartphone/ tablet/laptop/ and stable internet connectivity for web-based video conferencing.
4.Participants who can come for follow up at least on two occasions: after 1 week and 12 weeks of initial recruitment in the PTR program.
 
 
ExclusionCriteria 
Details  1. Dementia/ cognitive impairment or symptomatic psychiatric illness.
2. Impaired hearing and / or vision leading to inability to understand instructions.
3. The home environment is not conducive to the installation and use of rehabilitation equipment.
4. Inability to perform exercise due to orthopaedic / exercise-induced hypoxemia or other medical conditions which precludes physical exercises.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measures:
1.Difference in the mean COPD Assessment Test (CAT) scores in the intervention and control group at baseline and after 12 weeks of follow up.
2.Difference in the mean 6-min walk distance and 30-sec sit-to-stand test (30STS) in the two groups at baseline and after 12 weeks of follow up.
3.Difference in the mean FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in 1 second) and FEV1/FVC values in the two groups at baseline and after 12 weeks of follow up.
4.Difference in mean quality of life scores, assessed by EuroQol-5D-3L (EQ-5D-3L), in the intervention and control groups at baseline and after 12 weeks of follow up.
 		 Primary outcomes of the intervention and control groups shall be assessed both at baseline and after 12 weeks of intervention to evaluate the effectiveness of Pulmonary Tele-rehabilitation (PTR) in the management of COPD. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   01/09/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Study Title: Effectiveness of Adjunct Supervised Pulmonary Tele-rehabilitation as Compared to Standard Treatment in the Management of Chronic Obstructive Pulmonary Disease at a Tertiary Care Hospital in Delhi: A Randomised Controlled Trial
Rationale: Studies comparing facility based Pulmonary Rehabilitation (PR) with home-based Pulmonary Tele-rehabilitation (PTR) have demonstrated that COPD patients engaging in Pulmonary Tele-rehabilitation (PTR) experience similar improvements in walking capacity, respiratory symptoms, quality of life, physical fitness, and muscle strength. Thus, PTR holds considerable promise in bridging the access gap by addressing challenges related to transportation, cost, and mobility limitations, making it a compelling alternative to facility-based pulmonary rehabilitation for COPD management. [10,14-16] In India, PTR remains under-researched, with mainly review articles available. No study comparing PTR with standard COPD management in the Indian context was found. This study aims to fill that gap.
Aim: To evaluate the effectiveness of supervised Pulmonary Tele-rehabilitation (PTR) for its potential integration into chronic obstructive pulmonary disease (COPD) management protocol as an adjunct to standard treatment.
Primary objectives:
1. To assess the effect of supervised PTR as an adjunct to standard management on symptoms and functional abilities (changes in six-minute walk test (6MWT), 30-sec sit-to-stand test (30STS) and pulmonary function test) in newly diagnosed cases of COPD after 12 weeks of initiation of treatment in a tertiary care hospital in Delhi (intervention group). 
2. To assess the effect of standard management on symptoms and functional abilities in newly diagnosed cases of COPD after 12 weeks of initiation of treatment (control group).
Secondary objectives:
1. To compare the symptoms and functional abilities in the intervention and control groups after 12 weeks of initiation of treatment.
2. To compare the difference in quality of life in these two groups after 12 weeks of initiation of treatment.
Study design:      A Randomised Controlled trial
Study period:      August 2025 – November 2026
Study Setting:     Community-based
Place of Study:    Catchment area of GTB Hospital, a tertiary care hospital in Delhi. Recruitment of participants
                              would be done from OPD of Department of Respiratory Medicine, GTB Hospital.
Study participants: Newly diagnosed COPD cases visiting the Respiratory Medicine Outpatient Department 
                                  (OPD) at GTB Hospital.
Sample size: The required sample size for the study was 128 participants (64 in each group). Accounting for a potential 10% dropout rate, the final adjusted sample size was calculated as 144 participants (72 in each group).
Methods: A randomised controlled trial would be carried out to compare the effectiveness of PTR with standard management in newly diagnosed COPD patients attending the Respiratory Medicine Outpatient Department (OPD) at GTB Hospital. A total of 144 participants meeting the inclusion criteria will be recruited over a three-month period, with 72 participants allocated to each of the intervention and control groups using block randomisation. The intervention group will receive an initial in-person pulmonary rehabilitation (PR) session conducted by the investigator with the help of a physiotherapist specifically trained in PR in addition to the standard treatment and an educational e-booklet and instructional videos in Hindi language. Educational sessions as a part of PR covering key topics such as COPD management, benefits of PTR, lifestyle modification, nutrition, smoking cessation, inhalation techniques, and information with regard to recognition of early signs of exacerbation would also be provided to them. Participants will then undergo remotely supervised PTR sessions (50–60 minutes) via a web-based video conferencing platform, three times per week for the next 12 weeks. 
The control group participants will receive only standard treatment, initiated immediately upon diagnosis, without PTR.
Symptoms of COPD, lung function and quality of life shall be assessed both at baseline and after 12 weeks of intervention. The study will compare both primary and secondary outcomes between the intervention and control groups to evaluate the effectiveness of Pulmonary Tele-rehabilitation (PTR) in the management of COPD.
Primary outcome measures:
1. Difference in the mean COPD Assessment Test (CAT) scores in the intervention and control group at baseline and after 12 weeks of follow up.
2. Difference in the mean 6-min walk distance and 30-sec sit-to-stand test (30STS) in the two groups at baseline and after 12 weeks of follow up.
3. Difference in the mean FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in 1 second) and FEV1/FVC values in the two groups at baseline and after 12 weeks of follow up.
Secondary outcome measures
1. Difference in mean quality of life scores, assessed by EuroQol-5D-3L (EQ-5D-3L), in the intervention and control groups at baseline and after 12 weeks of follow up.
Statistical analysis: Analysis will be done based both on Intention to Treat and Per Protocol principle. Continuous variables would be summarized using means and standard deviations. Categorical variables will be expressed as proportions. Between-group comparisons of continuous variables will be performed using independent t-tests, and categorical variables will be analysed using the chi-square test. A p-value < 0.05 will be considered statistically significant.

 
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