| 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
|
|
|
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
|
|
|
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. |