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CTRI Number  CTRI/2025/07/090005 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   How Lung Therapy Supports People with COPD at a Primary Health Center in Chh. Sambhajinagar to Improve Breathing and Quality of Life 
Scientific Title of Study   Screening Approach & the effect of Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disorder in Primary Healthcare Centre at Chh. Sambhajinagar 
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 Kapil Garg 
Designation  Associate Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Musculoskeletal Physiotherapy

Aurangabad
MAHARASHTRA
431003
India 
Phone  9027612715  
Fax    
Email  kapilgarg@mgmiop.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bela Agarwal 
Designation  Professor 
Affiliation  MGM Institute oh Health Sciences 
Address  Department of Cardio Respiratory Physiotherapy

Mumbai
MAHARASHTRA
410206
India 
Phone  9819000674  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bela Agarwal 
Designation  Professor 
Affiliation  MGM Institute oh Health Sciences 
Address  Department of Cardio Respiratory Physiotherapy

Mumbai
MAHARASHTRA
410206
India 
Phone  9819000674  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  mgm iNSTITUTE OF hEALTH sCIENCES  
Address  Kamothe Navi Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kapil Garg  PHC Centers  Khuldabad & Daulatabad (PHC Centers) MGM Hospital
Aurangabad
MAHARASHTRA 
9027612715

kapilgarg@mgmiop.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects  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  nil  nil 
Intervention  Pulmonary Rehabilitation  1. Pulse lip Breathing 10 Rep with 2 sets with 1 min interval 2. Respiratory muscle- strengthening exercises (I-MT) With intensity of 40% of their baseline MIP using the threshold IMT device with a resistance load of 9– 41 cm H2O. 10 Min (5 min for inspiration and 5 min for expiration) 3.Aerobic exercises Will be given by upper limb and lower limb cycling with portable cycle ergometry. 10 Min under supervision 05 min with upper limb and 05 min for lower limb with minimal tolerable resistance. Patient may take break if they feel uncomfortable & perform again. 4. Upper Limb Exercises with Resistance band 10 Rep shoulder Flexion / Abduction and Rowing will be performed with the resistance band 5. Lower Limb Exercises 10 Rep of SLR one set without hold till 4 weeks, With hold of 5 seconds till 8 weeks one set With hold of 10 seconds till 12 weeks 2 sets 6. Breath Hold at Maximum Expiration 10 Rep with hold up-to 5 sec for 6 weeks 10 rep with hold up-to 10 sec from 7 week to 12 week 7. Thoracic Mobility Exercises 10 Rep of each side (extension & lateral banding one set up-to 4 weeks 10 Rep of each side (extension & lateral banding one set up-to 12 weeks (2 sets) 8. Lung clearance techniques as indicated Active Cycle of Breathing 3 Mins. 9. Coughing /Huffing 5 rep which is possible by patients if secretion would be present only.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients diagnosed COPD (GOLD 1-4) by physician or with Spirometry following consultation with medical officer 
 
ExclusionCriteria 
Details  Patients with abdominal surgeries with in last 3 months
Patients with neurological or cognitive disorders.
Patients with severe (Grade 2 or above) spinal deformity
Patients with any lower limb structured deformity
Tuberculosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnose COPD (Prevalence of COPD )  12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Lung Function Test
Oxygen saturation
Respiratory muscle strength
Exercise capacity
Quality of Life 
12 Weeks 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   01/08/2025 
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="2"
Months="0"
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  

In this study we are going to cover PHC centre (Khuldabad & Daulatabad) at Chh Sambhajinagar comes under MGM Hospital.  Following approval from the ethical committee, the total population of the village will be identified, with a focus on selecting the target population aged between 40 and 70 years. Once the target population has been determined, the screening process for COPD will be initiated. Subjects will be screened based on predefined inclusion and exclusion criteria. All individuals within the target age group who visit the Primary Health Centre (PHC) with health-related concerns will be evaluated according to these criteria. The screening process will be conducted under the supervision of a Medical Officer from the Department of Preventive and Social Medicine, utilizing spirometry software, which is recognized as a reliable and validated tool for assessing lung function. Individuals who are suspected of having COPD based on the initial screening will be referred to a pulmonologist for confirmation of the diagnosis. Written informed consent will be obtained from all patients diagnosed with COPD, prior to their participation in further evaluation and the pulmonary rehabilitation program

Pre Intervention Readings:-

1. Lung Function Test will be done by Spirometry Software. In this procedure, the patients will be instructed to sit in an upright position. Flow Turbine will be given to patients with mouth piece. We instruct the patients to inhale deeply and exhale force fully three times. Best values of Lung function test as FEV1 (Force Expiratory Volume 1), FVC (Force Vital Capacity) & TLC (Total Lung Capacity) will be noted. 

2. 1. For oxygen saturation finger Pulse Oxymeter will be used on first or middle finger and value of oxygen saturation SPO2 will be recorded.

3. 1. For respiratory muscle strength we will use Mouth pressure meter. Maximal Inspiratory Pressure (MIP) & Maximal Expiratory Pressure (MEP) Measures the strength of the inspiratory & expiratory muscles respectively. Mouth pressure measurement is a simple and non-invasive technique used to evaluate respiratory muscle strength, particularly the strength of the inspiratory

 

and expiratory muscles. During evaluation the patient should be seated comfortably in an upright

position & should seal their lips tightly around the mouthpiece, ensuring there is no air leakage. For MIP patient has take a deep breath in and then exhale fully. After exhalation, ask them to inhale forcefully (inhalation should be as deep and forceful as possible). The mouth pressure meter device will record the maximum inspiratory pressure generated during the forceful inhalation. Same for MEP patients ask to take a deep breath in and then exhale forcefully through the mouthpiece. The expiration should be as fast and forceful as possible. The mouth pressure meter will record the maximum expiratory pressure generated during the forceful exhalation. This test is also typically repeated three times, with the highest value being recorded.

4. 6 minute walk test will be used to evaluate exercise capacity (cardiorespiratory endurance). It measures the distance a patient can walk in 6 minutes, which reflects their overall functional capacity and endurance. During this test patient is instructed to wear comfortable clothing and shoes. On a flat surface of at least 30 meters, patient’s instructed to walk at their own pace, and can encouraged to walk as far as possible without running. We evaluate the baseline vitals including heart rate, blood pressure, oxygen saturation and record usual symptoms like dyspnea or fatigue. During the test, the patient walks for 6 minutes, and allowed for resting if needed, but should resume walking once will be able. Monitor vital signs, especially oxygen saturation, and provide supplemental oxygen if saturation falls below 88% or 90%. Afterward, assess recovery and repeat vital signs. The total distance walked in meters is the primary measure of exercise capacity

5. 1. St George’s Respiratory Questionnaire (SGRQ) will be used for evaluation of Quality-of-Life. The St George’s Respiratory Questionnaire (SGRQ) is a widely used tool to assess the health-related quality of life (HRQoL) in patients with COPD. SGRQ consists of 50 items divided into three domains, including Symptoms, Activity & Impact. The SGRQ score is calculated for each domain, and an overall total score is derived. The scores range from 0 to 100, where 0 indicates no impairment and 100 represents the maximum possible impairment.

• All the patients will be divided into subgroups based on aged ie: 40-50, 51-60, 61-70 years for further aged wise analysis.

• Patient education will be given by the researcher. Recorded sessions by Psychologist along with Diet charts prescribed by Dietician will also be provided once a month.

• Patients diagnosed with COPD will be referred to a pulmonologist for medical management.

• After the pre-intervention readings have been recorded, pulmonary rehabilitation will be initiated, which will include an exercise protocol and breathing training conducted at the PHC Centre. The pulmonary rehabilitation protocol has been designed in accordance with the guidelines provided by the British Thoracic Society and the Australia and New Zealand Pulmonary Rehabilitation Clinical Practice Guidelines with PIR Issued by WHO for pulmonary rehabilitation, we will provide exercises that include all the basic pulmonary rehabilitation exercises. During the evaluation of outcomes, patient feedback will be collected to assess the feasibility of the pulmonary rehabilitation program All the exercises will be performed for 12 weeks 2 days per week at PHC under supervision and 4 days at home followed by at 6 month and 12-month follow-up.  

Sr No

Exercises

No of Repetitions

1. 

Pulse lip Breathing

10 Rep with 2 sets with 1 min interval

2. 

Respiratory muscle- strengthening exercises (I-MT)

With intensity of 40% of their baseline MIP using the threshold IMT device with a resistance load of 9– 41 cm H2O. 

10 Min  (5 min for inspiration and 5 min for expiration)

3. 

Aerobic exercises

Will be given by upper limb and lower limb cycling with portable cycle ergometry.

10 Min under supervision

05 min with upper limb and 05 min for lower limb with minimal tolerable resistance. Patient may take break if they feel uncomfortable & perform again.

4. 

Upper Limb Exercises with Resistance band

10 Rep shoulder Flexion / Abduction and Rowing will be performed with the resistance band

5. 

Lower Limb Exercises

10 Rep of SLR one set without hold till 4 weeks,

With hold of 5 seconds till 8 weeks one set

With hold of 10 seconds till 12 weeks 2 sets

6. 

Breath Hold at Maximum Expiration

10 Rep with hold up-to 5 sec for 6 weeks

10 rep with hold up-to 10 sec from 7 week to 12 week

7. 

Thoracic Mobility Exercises

10 Rep of each side (extension & lateral banding one set up-to 4 weeks

10 Rep of each side (extension & lateral banding one set up-to 12 weeks (2 sets)

8. 

Lung clearance techniques as indicated

Active Cycle of Breathing 3 Mins. 

9. 

Coughing /Huffing

5 rep which is possible by patients if secretion would be present only.    


• All the patients will be trained for home-based exercises including pursed lip breathing, coughing/ huffing, spirometer, SLR, Breath Hold at Maximum Expiration & Thoracic Mobility Exercises For remaining 4 days in a week. One Dairy will be issued and maintained for monitoring of the patients by the patients. We will issue a diary to Patients & asked them to maintain that diary at home whenever they perform home based exercise. We will instruct the patients to give miss call on the provided mobile no for confirmation of exercises. In-case if we will not get miss call, we will call the patient and do the confirmation.

 
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