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CTRI Number  CTRI/2023/05/053130 [Registered on: 25/05/2023] Trial Registered Prospectively
Last Modified On: 10/05/2023
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   A clinical trial to study the effect of exercises to improve quality of life in patients with COPD.  
Scientific Title of Study   Comparison of the effects of upper limb endurance and strength training on pulmonary functions, dyspnea, health related quality of life and functional outcomes in patients with COPD.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Santosh Kumari  
Designation  PG Student 
Affiliation  college of physiotherapy, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak 
Address  college of physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
college of physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  8708772106  
Fax    
Email  singhdrrita2023@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gitanjali Sikka  
Designation  Assistant professor 
Affiliation  college of physiotherapy, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak 
Address  college of physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
college of physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  7027192620  
Fax    
Email  gsikka.cphy@uhsr.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Pawan Singh 
Designation  Associate professor 
Affiliation  Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak 
Address  Department of pulmonary and critical care medicine(PCCM), room no. 17D, C-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
Ch. Ranbir Singh OPD, room no.129 & 130, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  8437013094  
Fax    
Email  ga.ps.complete@gmail.com  
 
Source of Monetary or Material Support  
College of physiotherapy, Pt. B.D. Sharma PGIMS, UHS Rohtak  
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak Haryana India 
Address  college of physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak 
Type of Sponsor  Government medical college 
 
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 Pawan Kumar Singh  Pt. B.D. Sharma, PGIMS,UHS Rohtak  Ch. Ranbir Singh OPD, Respiratory medicine(PCCM), room no.129 & 130, Pt. B. D. Sharma University of health sciences, PGIMS, Rohtak
Rohtak
HARYANA 		 8437013094
9100000000
ga.ps.complete@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma post graduate institute of medical sciences, UHS, Rohtak  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 
Intervention  Endurance training  COPD patients will be given upper limb endurance training during pulmonary rehabilitation program for 4 weeks. 
Comparator Agent  Pulmonary functions, dyspnoea, health related quality of life and functional outcomes.  FEV1, FVC, FEV1/FVC, Modified Borgs dyspnoea score, SGRQ, CAT Score DASS-21 Hindi, 6MWT and activity specific task all will be recorded prior to intervention and after 4weeks of intervention and later at follow-up i.e. at 8th week.  
Intervention  Strength training  COPD patients will be given upper limb strength training during pulmonary rehabilitation program for 4 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Men and women diagnosed with COPD according to GOLD criteria above the age of 40 years old will be recruited from OPD of Pt. B.D.S. PGIMS Rohtak.
2. COPD stages from 2 to 4 (A-D) diagnosed according to GOLD criteria.
3. FEV1/FVC <0.7 and FEV1 <80% of predicted value.
4. Subjects undergoing stable respiratory medication with no exacerbations.
5. Patients willing to participate and given informed consent. 
 
ExclusionCriteria 
Details  1. Subjects with acute exacerbation.
2. Have severe cognitive or psychotic impairment.
3. Musculoskeletal or neurological conditions that prevent exercise.
4. Unstable cardiovascular disease (e.g., unstable angina, aortic valve disease, unstable
pulmonary hypertension).
5. Patients requiring oxygen supplementation during exercise.
6. Patients with incapacity to follow a standard rehabilitation program.
7. Patients with shoulder pain, shoulder osteoarthritis, or shoulder surgery.
8. Rib fracture or a relevant infectious disease.
9. Pregnant or breastfeeding women.
10. H/O pneumonectomy or lobectomy in past 6month
11. Non-cooperative patients or patients under tutorship or curatorship.
12. Suffering from another disease like pulmonary hypertension or lung cancer.
13. Uncontrolled comorbidity on physician discretion. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pulmonary functions-
Forced Expiratory Volume in 1 second (FEV1)
Forced Vital Capacity (FVC)
FEV1/FVC
2. Dyspnoea- Modified Borg’s scale (Hindi version) 		 Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quality of life and dyspnoea associated with activities of daily living assessment
-SGRQ Hindi version
-COPD assessment test score CAT Hindi version
2. Psychological status assessment – anxiety and
depression scale DASS 21-Hindi
3. Functional outcomes-
• 6MWT
• Arm activity levels
4. Dyspnoea will be assessed after 6MWT Time to complete an activity (Glittre ADL’S test, PNF pattern D1-D2 with 0.5kg
of weight, Grocery shelving task and Blackboard erasing task 		 Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   30/05/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   “The purpose of our study is to compare the effects of upper limbs endurance exercise training versus upper limbs strength exercise training in improving dyspnoea, FEV1, arm activity levels, exercise capacity, functional outcomes and HRQoL in patients with COPD during pulmonary rehabilitation program. In patients with COPD, Pulmonary rehabilitation plays a very important role. When a person with COPD performs exercises regularly there’s some improvement in the breathlessness and strength and endurance to perform their daily life activities, and their health related quality of life improved by improvement in the exercise capacity .Thus on account of this, we want to study and compare the effectiveness of upper limb endurance training and upper limb strength training and will help them to improve their quality of life and reduces their hospital stay and somehow will improve their anxiety and depression state of mind. Patients have to perform some exercises according to their health status for 4weeks, 3times a week for atleast 90min and have to fill different scales/parameters prior to training and after 4 weeks of training. 
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