| CTRI Number |
CTRI/2025/02/080403 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of Physical activity on degrees of Depression, Anxiety and Quality of Life in elderly people visiting a Super-specialty hospital in Gangtok: A cross-sectional study |
|
Scientific Title of Study
|
Association of Physical Activity on Levels of Depression, Anxiety and Quality of Life in Elderly Reporting to a Tertiary Care Hospital in Gangtok: A Cross- sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudarshana Deori |
| Designation |
Post graduate student |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, Physiotherapy department, room no-505, 5th mile, Upper Tadong , Gangtok
East
SIKKIM
737102
India |
| Phone |
9933311956 |
| Fax |
|
| Email |
sudarshanadeory@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bishal Bista |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, Physiotherapy department, room no- 505, 5th mile, Upper Tadong , Gangtok
East
SIKKIM
737102
India |
| Phone |
9593782814 |
| Fax |
|
| Email |
bishal.b@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Nikita joshi sonowal |
| Designation |
Head of Department |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, Physiotherapy Department, room no- 505, 5th mile, Upper Tadong , Gangtok
East
SIKKIM
737102
India |
| Phone |
9932470754 |
| Fax |
|
| Email |
nikita.j@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central referrral hospital |
| Address |
near canara bank 5th mile , upper tadong , Gangtok, East-Sikkim, pin code: 737102 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Bishal bista PT |
Central Referral Hospital |
level 5, room no 505, upper tadong , 5th mile, gangtok , east sikkim, pin code 737102
East
SIKKIM |
8918387371
bishal.b@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening to know how Physical Activity associates with level of depression, anxiety , and Quality of life in Elderly |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All genders 60 years and above willing to give informed and voluntary consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Uncorrected visual problems
Lack of consent to participate in the study
Cognitive impairments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical Activity Scale for Elderly; Geriatric Depression Scale-15;Generalized Anxiety Disorder-7;WHOQOL-BREF |
1 time study, 1 time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
01/05/2025 |
| 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)
|
Completed |
| 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
|
In my upcoming study i will be checking the association of physical activity on levels of depression,anxiety and quality of life. The participant information sheet will be provided and informed consent will be obtained prior to the commencement of the study. Screening of the participants for the study according to eligibility criteria will be done.
To evaluate the physical activity of the participants physical activity scale for elderly will be used for evaluation of depression by geriatric depression scale 15, for anxiety Generalized anxiety disorder 7 and for quality of life WHOQOL BREF will be used. |