| CTRI Number |
CTRI/2017/08/009410 [Registered on: 18/08/2017] Trial Registered Prospectively |
| Last Modified On: |
17/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation |
| Study Design |
Other |
|
Public Title of Study
|
To find out relation between physical fitness and quality of life in copd |
|
Scientific Title of Study
|
Correlation of Physical Fitness Components with Health related Quality of Life in COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kalyan Chakravarthy |
| Designation |
Associate Professor |
| Affiliation |
SOAHS |
| Address |
Dept of physiotherapy
Manipal University
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
998629740 |
| Fax |
|
| Email |
kalyan.reddy@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kalyan Chakravarthy |
| Designation |
Associate Professor |
| Affiliation |
SOAHS |
| Address |
Dept of physiotherapy
Manipal University
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
998629740 |
| Fax |
|
| Email |
kalyan.reddy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr kalyan Chakravarthy |
| Designation |
Associate Professor |
| Affiliation |
SOAHS |
| Address |
Dept of physiotherapy
Manipal University
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
998629740 |
| Fax |
|
| Email |
kalyan.reddy@manipal.edu |
|
|
Source of Monetary or Material Support
|
| department of physiotherapy, soahs,manipal university,karantaka,india |
|
|
Primary Sponsor
|
| Name |
Prabin Pradhan |
| Address |
Department of Physiotherapy
School of Allied Health Sciences, Manipal University, Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Mr Prabin Pradhan |
Kasturba Hospital |
physiotherapy department,alc centre,room 7
Udupi
KARNATAKA |
7848985490
newarprabin15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease(COPD), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Stable COPD patients, diagnosed at least for two years
Undergone cardiac evaluation at least once in last one year |
|
| ExclusionCriteria |
| Details |
Acute exacerbation within one month,
Patients on long term oxygen therapy,
Severe pulmonary hypertension (Right ventricular systolic pressure>60mmHg,
Unstable coronary artery disease,
Radiological emphysematous bullae and
Severe orthopaedic and neurological disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bio-electric Impedance Analyser ,
Chair Sit and Reach Test,
St. George Respiratory Questionnaire,
Hand held dynamo-meter,
6 minutes peg board and ring test, Bicycle ergo-meter |
Bio-electric Impedance Analyser ,
Chair Sit and Reach Test,
St. George Respiratory Questionnaire,
Hand held dynamo-meter,
6 minutes peg board and ring test, Bicycle ergo-meter -all the outcomes will be taken at the day 1 of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Saint George Respiratory Questionnaire |
day 1 of recruitment |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
01/09/2017 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives- To determine the correlation of physical fitness components with health related quality of life. Procedure- The following outcomes measure will be assessed: Subjects heights will be measured in standing position and body weight will be measured using weighing scale. Body composition will be determined using the device called bioelectric impedance analyser which subject need to hold the device in their hand for one minute and the device will provide information regarding the amount of fat in the body. To determine the exercise capacity subject will be made to exercise on a stationary bicycle. Subjects heart rate and oxygen level will be monitored closely. subjects will be made to exercise up to the point of maximum fatigue. Other test to be done includes measuring the strength of hand and leg muscle to determine how long subjects can sustain activity. subjects will be asked to place rings on the pegs for 6 minutes. |