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CTRI Number  CTRI/2024/11/077469 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 22/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   are individual with Chronic obstructive pulmonary disease at risk of fall 
Scientific Title of Study   Prevalence of Risk of Fall among Individuals with COPD visiting Out- Patient Services in Tertiary Care Hospitals 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananya S 
Designation  Post Graduate student 
Affiliation  M S Ramaiah university of applied sciences 
Address  M S Ramaiah college of physiotherapy, M S Ramaiah university of applied sciences, MSR Nagar MSRIT Post Bangalore-560054
902 Physiotherapy OPD, M S Ramaiah medical College hospital,MSR Nagar MSRIT Post Bangalore-560054
Bangalore
KARNATAKA
560054
India 
Phone  07349071677  
Fax    
Email  ananyanayak17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Diana Rodrigues 
Designation  Assistant Professor 
Affiliation  M S Ramaiah university of applied sciences 
Address  M S Ramaiah college of physiotherapy, M S Ramaiah university of applied sciences, MSR Nagar MSRIT Post Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9916247023  
Fax    
Email  rodriguesdiana10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Diana Rodrigues 
Designation  Assistant Professor 
Affiliation  M S Ramaiah university of applied sciences 
Address  M S Ramaiah college of physiotherapy, M S Ramaiah university of applied sciences, MSR Nagar MSRIT Post Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9916247023  
Fax    
Email  rodriguesdiana10@gmail.com  
 
Source of Monetary or Material Support  
M S Ramaiah college of physiotherapy, M S Ramaiah university of applied sciences, MSR Nagar MSRIT Post Bangalore-560054 
M S Ramaiah memorial hospital New BEL road MSR nagar MSRIT post-560054 
 
Primary Sponsor  
Name  Ananya  
Address  M S Ramaiah college of physiotherapy-M S Nagar MSRIT Post Bangalore-560054 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ananya S  M S Ramaiah medical college hospital  M S Ramaiah medical college hospital, Department of Respiratory Medicine 1st floor room no-028 , MSR Nagar MSRIT Post Bangalore-560054
Bangalore
KARNATAKA 
7349071677

ananyanayak17@gmail.com 
Ananya S  M S Ramaiah memorial hospital  M S Ramaiah memorial hospital Respiratory Medicine department ground floor MSR Nagar MSRIT Post Bangalore-560054
Bangalore
KARNATAKA 
07349071677

ananyanayak17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah Medical College  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 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with COPD and stable on treatment
Individuals aged 40-60yrs
Individuals with stable cardiovascular conditions (i.e. no chest discomfort, tachycardia, ect..)
 
 
ExclusionCriteria 
Details  Neurological disorders affecting balance and walking
Individuals with musculoskeletal mobility difficulty
Those who cannot perform the test
Individuals already undergoing rehabilitation
• Individuals diagnosed with diabetic neuropathies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
timed up and go test  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/12/2024 
Date of Study Completion (India) 01/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress and is one of the most important causes of death worldwide .Studies suggest that the people living with COPD also suffer from many non-respiratory manifestations including skeletal muscle dysfunction, systemic inflammation, nutritional depletion and malnutrition. The estimated global burden of COPD was 300 to 400 million globally between 2018 and 2019. India ranks number two globally with an estimated 37.8 million cases of COPD, contributing to 17.8% of the global burden of COPD as reported in study by Elroy Boers et al. The prevalence of COPD varies across different regions and states of India. Karnataka is ranked sixth among other states in terms of the prevalence of COPD ,with the prevalence reported to be 4.36% in Bangalore

Risk factors for COPD include smoking, use of cooking fuel, biomass fuel and firewood, outdoor air pollution, increasing age, occupation, gender, pulmonary impairment after tuberculosis. The risk of COPD increases with age, education level, lack of awareness about the health effects of smoking, poorer socioeconomic status, high air pollution regions, and more exposure to tobacco smoke and dust from occupations.


According to the Global Initiative for Chronic Obstructive Lung Diseases (2018), skeletal muscle dysfunction is one of the most common extra-pulmonary symptoms observed in COPD patients, accounting for 384 million cases of the disease. This dysfunction is characterized by decreased muscle strength and endurance. Peripheral and respiratory muscles are both affected by skeletal muscle dysfunction in COPD. Peripheral muscle functioning in both the upper and lower limbs is impaired in patients with COPD; however, the abnormalities are more severe in the lower limbs. The muscle group most affected is the quadriceps. As a result Patients with COPD have impaired balance and a higher risk of fall.

The prevalence of COPD fallers was reported to be 30%, and frequent fallers was 24%. The incidence rate of falls in stable COPD varied from 1.17 to 1.49 falls/person-year .Evidence suggests that identification of risk factors for falls may help in improving the understanding of screening for those at risk and help in forming the protocol for falls prevention programs. 

 

Risk of fall in elderly is assessed using the Timed-Up and Go(TUG) test. A TUG score of 10.9 seconds corresponds to 100% sensitivity and 97% specificity in assessing risk of fall in elderly. Among the various tests used to assess risk of fall the TUG Test and Berg balance scale have been proven to be reliable and validatedtools for evaluating risk of fall in individuals with COPD . A TUG score with a cutoff time of 12- seconds demonstrated high sensitivity and specificity (93% and 74% respectively) while evaluating risk of fall in patients with COPD.


Incorporating the TUG into the clinical setting for COPD patient evaluation would be simple and less time consuming. It has the ability to predict risk of fall. However, the paucity of literature on prevalence of risk of fall among COPD individuals visiting out-patient services in tertiary care hospitals defines the need of this study. Therefore, this study aims to determine the prevalence of risk of fall among individuals with COPD visiting out-patient services in tertiary care hospitals.

 
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