FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092938 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Study to Assess the occurrence of loss of muscle mass and strength among patients Suffering from lung disease Chronic Obstructive Pulmonary Disease (COPD) attending outdoor department of Department of Medicine GSVM Medical College, Kanpur 
Scientific Title of Study   A STUDY TO ASSESS THE PREVALENCE OF SARCOPENIA AMONG SUBJECTS SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ATTENDING OUTDOOR DEPARTMENT AT A TERTIARY HEALTH CARE CENTRE OF NORTH INDIA 
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 Himanshu Maurya 
Designation  Junior Resident 
Affiliation  KPS Post Graduate Institute of Medicine , GSVM Medical college kanpur 
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  8052038366  
Fax    
Email  himanshumaurya601@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Himanshu Maurya 
Designation  Junior Resident 
Affiliation  KPS Post Graduate Institute of Medicine , GSVM Medical college kanpur 
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  8052038366  
Fax    
Email  himanshumaurya601@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Himanshu Maurya 
Designation  Junior Resident 
Affiliation  KPS Post Graduate Institute of Medicine , GSVM Medical college kanpur 
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  8052038366  
Fax    
Email  himanshumaurya601@gmail.com  
 
Source of Monetary or Material Support  
GSVM Medical College Kanpur 
 
Primary Sponsor  
Name  GSVM Medical College Kanpur 
Address  Swaroop Nagar Kanpur 
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 
Himanshu Maurya  LLR Hospital GSVM Medical College Kanpur  Room No 24 Department of Medicine GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH 
8052038366

himanshumaurya601@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Subjects with diagnosis of COPD based on GOLD Guidelines 2025 and having severity of obstruction as GOLD 1-3 and belonging to GOLD Class A & B.
Haemoglobin level equal to or more than 8 g per dl
Stable subjects with co-morbidities like diabetes (with HbA1c less than 10 percent hypertension with systolic BP less than140 and DBP less than 90 mm Hg hypothyroidism or hyperthyroidism with normal thyroid function on appropriate therapy CKD stage 1 and 2 Heart Failure NYHA class I and II will be eligible for participation. They should be on stable dose for last at least three months.
 
 
ExclusionCriteria 
Details  Acute on chronic exacerbation of COPD
Presence of Cor Pulmonale
History of hospitalization in last three months
Malignancy
CKD (stage greater than or equal to 3)
Heart Failure (NYHA III or IV)
COPD with severity of obstruction GOLD 4 and GOLD Stage E
Neuromuscular disease (such as myasthenia gravis, MND)
Stroke or other neurologic disorder with residual deficit
Infections like HIV, active pulmonary or extrapulmonary TB
Critical illness
Organ transplant or immunosuppression
Pregnancy or lactation
Long term steroid use (except inhaled or topical)
Bedridden subjects due to their inability in performing the required tests
Subjects having locomotor abnormalities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Sarcopenia among subjects with COPD  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life using SARQOL  Single 
 
Target Sample Size   Total Sample Size="318"
Sample Size from India="318" 
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="6"
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 - NO
Brief Summary  

Sarcopenia, a progressive loss of skeletal muscle mass, strength, and function, is increasingly recognised as a major comorbidity in patients with Chronic Obstructive Pulmonary Disease (COPD). Though commonly linked to ageing, sarcopenia often develops earlier in COPD due to chronic systemic inflammation, oxidative stress, physical inactivity, malnutrition, and prolonged corticosteroid use. It worsens respiratory function, limits exercise capacity, and leads to greater fatigue and physical inactivity, creating a vicious cycle of muscle degradation. These impairments result in loss of independence, social isolation, and psychological distress. Sarcopenic COPD patients consistently show poorer scores on quality-of-life. Sarcopenia increases morbidity by contributing to more frequent exacerbations, prolonged hospital stays, and higher readmission rates. The loss of both respiratory and peripheral muscle mass diminishes the ability to recover from illness, while balance impairment increases the risk of falls and fractures. Importantly, sarcopenia is an independent predictor of both all cause and COPD-specific mortality. Early identification and timely interventions such as nutritional supplementation and pulmonary rehabilitation can significantly reduce morbidity and mortality.

 
Close