| CTRI Number |
CTRI/2025/07/091584 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational Study |
| Study Design |
Other |
|
Public Title of Study
|
How Fatigue and Mental Health Affect Daily Activity and Life Quality in People with COPD
|
|
Scientific Title of Study
|
Association of fatigue and mental health with level of physical activity and quality of life in COPD patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708765258 |
| Fax |
|
| Email |
swatikundu102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swati |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8708765258 |
| Fax |
|
| Email |
swatikundu102@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, 124001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, 124001, Haryana, India |
| 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 |
| Dr Swati |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Department of Pulmonary and Critical Care Medicine(PCCM),PGIMS
Rohtak
HARYANA |
8708765258
swatikundu102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are clinically diagnosed with COPD |
|
| ExclusionCriteria |
| Details |
Lung cancer or other lung diseases; known inflammatory disease, Stroke, Severe heart disease, Kidney diseases, Liver disease, Psychosocial or physical disorders that might interfere with the assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue, Mental health, Level of physical activity, Quality of life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients would be chosen from PGIMS, Rohtak’s Department of PCCM .Patients with COPD will be screened as per the inclusion and exclusion criteria of the study. Patient assessment will be done using patient proforma; and sociodemographic details and participation will be recorded. Patients who will meet the inclusion criteria will be given information about mode of performance and the risks involved in the study using patient information sheet by the therapist before recruitment. Informed consent will be taken from all the participants /patients who met the inclusion criteria using patient consent form. Aims and objectives will be clearly explained to the selected Subjects. To assess the severity of COPD, lung function testing will be done. To assess the level of fatigue, FACIT-F and MIFS questionnaire will be used. To assess the level of mental health, HADS Questionnaire will be used. To assess the level of physical activity, IPAQ Questionnaire will be use. To assess the quality of life, SGRQ Questionnaire will be used. |