| CTRI Number |
CTRI/2024/11/077376 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
corelational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Screening of Balance and Functional Mobility in individuals with COPD |
|
Scientific Title of Study
|
Screening of Balance and Functional Mobility in individuals with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gamit Prakruti Mukesh |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
08980958735 |
| Fax |
|
| Email |
prakrutig2613@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hardini Prajapati |
| Designation |
Lecturer, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
9898550634 |
| Fax |
|
| Email |
drhardini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardini Prajapati |
| Designation |
Lecturer, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
GUJARAT
380060
India |
| Phone |
9898550634 |
| Fax |
|
| Email |
drhardini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India |
| Type of Sponsor |
Private 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 |
| Dr Hardini Prajapati |
Ahmedabad Institute Of Medical Sciences |
Room no 1 Devision Exercise Therapy Department Physiotherapy
Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT |
9898550634
drhardini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research And Ethics Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects who are diagnosed with COPD. (According to GOLD classification Grade 1&2)
2. Male with age group between 40-60 years (AUGUSTAN classification).
3. smokers, non-smokers, ex-smokers.
4. Patient who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Patient who are (GOLD Classification Grade III & IV)
2. Patient having any kind of infection , neurological deficits, psychological illness, cardiac conditions.
3. Patient who has recent surgeries or trauma.
4. Patient who are unable to communicate due to language impairment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini-BESTest (Balance Evaluation Systems Test)
|
At baseline and immediate after observation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pulmonary Function test
2. Timed Up and Go test |
At baseline and immediate after observation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2025 |
| 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="0"
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
|
•NEED
OF THE STUDY
•There
are studies which shows that in Chronic Obstructive Pulmonary Disease, there is
reduction in muscle mass, strength, endurance, hypoxia, osteoporosis and
cognitive impairment. All these impairments may affect balance of the patient.
Thus, the need of the study arises to check the balance in individuals with
COPD.
•AIM
OF THE STUDY:
•To
assess the balance in individuals with chronic obstructive pulmonary disease. •OBJECTIVES:-
•To
evaluate balance in Chronic Obstructive Pulmonary Disease patients.
•To evaluate functional mobility in Chronic Obstructive Pulmonary Disease patients.
•To
find the co-relation between balance and severity of the Chronic Obstructive
Pulmonary Disease. |