| CTRI Number |
CTRI/2024/09/074076 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Brisk walking on depression.A non randomized clinical trial. |
|
Scientific Title of Study
|
Effectiveness of brisk walking on depression.A non-randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanoy sutradhar |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technogy. |
| Address |
Room no:304, Department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01780858730 |
| Fax |
|
| Email |
ysd123err@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of science and Technology. |
| Address |
Room no:304, department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of science and Technology. |
| Address |
Room no:304, department of Physiotherapy and Rehabilitation, Dr.
M R Khan Medical Center, Jashore University of Science and
Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| This is a fully Self funded.
Dr.
M R Khan Medical Center,Room no:304, department of Physiotherapy and Rehabilitation,Jashore University of Science and
Technology, Jashore- 7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Tanoy Sutradhar |
| Address |
Dr.
M R Khan Medical Center,Room no:304, department of Physiotherapy and Rehabilitation,Jashore University of Science and
Technology, Jashore- 7408, Bangladesh. |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| K M Amran Hossain |
Jashore University of science and technology |
Dr. MR khan medical center, Room no- 304, Physiotherapy and Rehabilitaion department, Jashore-7408, Bangladesh.
|
01735661492
amranphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mid, moderate or severe type of depression .Identify by the DASS-21 . |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brisk walking. |
•Participants in this group are willing to participate in this study. • They also receive approximately 30 minutes of brisk walking.
• 5 days Per week.
• 4 week need to the intervention
|
| Comparator Agent |
No intervention. |
Participant who are already depressed that are diagnosis from the previous reaeash in the jashore university of science and techonlogy but they are not willing to obey to participate this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1. Student at Jashore University of Science and Technology.
2. Subject that has already been diagnosed with depression, anxiety, and stress.
3. They own a smart phone, and within this phone, installed a Google Fit app that counts the daily activity, like footstep.
|
|
| ExclusionCriteria |
| Details |
1. Those who are not diagnosis with depression.
2. Participant who was refused to participate in this study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression level |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression |
4 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="0"
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)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Effectiveness of brisk walking on depression:This research will help determine
the best way to manage depressive symptoms. No prior research on the impact of
brisk walking exercise on depression has been done yet in Bangladesh. Moreover,
this study may focus on the possibility of other brain changes secondary to
physical activity. Hopefully, this finding helps to increase awareness about
the impact of brisk walking exercise on psychological well-being worldwide. |