| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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. |