| CTRI Number |
CTRI/2024/10/075447 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Physiotherapy regime on the management of Stress, Anxiety and depression in young adults |
|
Scientific Title of Study
|
Effectiveness of Integrated Physiotherapy Regime in the Management of Stress, Anxiety and Depression in Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Neuro Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
09530211310 |
| Fax |
|
| Email |
drvidhi@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhusudan Tiwari |
| Designation |
Dean and Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Dean and Principal Office, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Madhusudan Tiwari |
| Designation |
Dean and Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Dean and Principal Office, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk Road, Jaipur, Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Vidhi Gupta |
| Address |
3 573, Pradhan Marg, Malviya Nagar, Jaipur, Rajasthan 302017 |
| 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 |
| Dr Madhusudan Tiwari |
Mahatma Gandhi Hospital |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, Sitapura RIICO Institutional Area, Jaipur
Jaipur
RAJASTHAN |
09530211310
principal.physiotherapy@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F418||Other specified anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
An 8-week conventional physiotherapy home program involving Breathing exercises, Progressive Muscle Relaxation, lifestyle modification advice, and physical health counseling, with follow-up every 2 weeks. |
| Intervention |
Integrated Physiotherapy Regime |
8-week structured integrated physiotherapy regime for the management of stress, anxiety, and depression which will include breathing exercises, Progressive Muscular Relaxation, aerobic and anaerobic exercises, and resistance training with postural correction and lifestyle modification along with counselling. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
DASS 21 scale showing mild to moderate stress, anxiety, and depression
Physically fit to perform exercise having Normal HR, BP, and Body Composition
|
|
| ExclusionCriteria |
| Details |
Any Cardiovascular, neurological, and musculoskeletal conditions.
Age group less than 18 and more than 30 years
DASS 21 scale showing severe to extremely severe scores for stress anxiety and for depression.
Any other Psychological Condition except Stress, Anxiety, and Depression.
Patient on any prescribed medication for stress, anxiety and depression.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Beck Depression Inventory scale for Depression measurement
State-Trait Anxiety Inventory for Anxiety Measurement
Perceived Stress scale for stress measurement
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression Anxiety Stress Scale 21 |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
- 284 subjects will be selected among the Young Adults / Students
of Constituent colleges of MGUMST, Jaipur. Young Adults / Students who
will fulfill the inclusion criteria will be selected and written consent
will be taken before participation in this study. These subjects will be
allocated randomly into two groups:
Group A (n = 142) and Group
B (n = 142)
Group A: Will receive an
Integrated Physiotherapy Regime
Group B: will receive
Conventional Physiotherapy
Two months of treatment
will be given and data analysis will be done to see the effectiveness of the
treatment through appropriate statistical analysis tool |