| CTRI Number |
CTRI/2024/07/069934 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Main outcome of the study is correlation of physical activity with dyspnea, fatigue, frailty, and quality of life in participants having interstitial lung disease |
|
Scientific Title of Study
|
Correlation of physical activity level with level of dyspnea, fatigue, frailty, and quality of life in patients with interstitial lung diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya |
| Designation |
Pg student |
| Affiliation |
College of physiotherapy, pgims, rohtak |
| Address |
College of physiotherapy, pgims, rohtak
ROHTAK
HARYANA
124001
India
College of Physiotherapy, pgims, rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
8307582832 |
| Fax |
|
| Email |
senpriya0508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman |
| Designation |
Assistant professor |
| Affiliation |
College of physiotherapy, pgims, rohtak |
| Address |
College of physiotherapy, pgims, rohtak
Rohtak
HARYANA
124001
India
College of Physiotherapy, pgims, rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suman |
| Designation |
Assistant professor |
| Affiliation |
College of physiotherapy, pgims, rohtak |
| Address |
College of physiotherapy, pgims, rohtak
Rohtak
HARYANA
124001
India
College of Physiotherapy, pgims, rohtak
Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Bhagwat Dayal Sharma University of health sciences and research, Rohtak, Pin code- 124001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
College of physiotherapy PGIMS Rohtak |
| Address |
Pt. Bhagwat Dayal Sharma University of health sciences and research, Rohtak, pincode-124001, Haryana, India
Pin code- 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 Suman |
Pt. B. D. SHARMA, PGIMS/UHS, ROHTAK |
College of Physiotherapy
PGIMS, ROHTAK
Pincode- 124001
Haryana, India
HARYANA
Rohtak
HARYANA |
8814063412
sumanmehra2017@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: J80-J84||Other respiratory diseases principally affecting the interstitium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of interstitial lung disease with age between 40-75 years
2. Both male and female subjects will be included
3. Patients who are clinically stable and ambulant |
|
| ExclusionCriteria |
| Details |
1. Patients with any co-morbidities such as severe orthopaedic, neurological deficits or unstable cardiac disease
2. Patients who are unable to comprehend and respond to the questionnaires
3. Hypoxemic patients on long-term oxygen therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
International physical activity questionnaire
|
International physical activity questionnaire
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short form 36 questionnaire |
At day 0 |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
16/07/2024 |
| 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
|
Tilte of the study is correlation of physical activity level with level of dyspnea, fatigue, frailty, and quality of life in patients with interstitial lung diseases and it will include both male and female patients of sample size 65 . |