| CTRI Number |
CTRI/2020/11/028868 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
10/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of Impairment and Physical Activity Levels for Severe Mental Illness Individuals. |
|
Scientific Title of Study
|
Association between Disability and Physical Activity Levels in individuals with Serious Mental Illness |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Arun Shinde |
| Designation |
Post-graduate student |
| Affiliation |
Manipal College Of Health Professions, MAHE, Manipal |
| Address |
Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9594179869 |
| Fax |
|
| Email |
rahulshnd1022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinita A Acharya |
| Designation |
Associate Professor Occupational Therapy |
| Affiliation |
Manipal College Of Health Professions, MAHE, Manipal |
| Address |
Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Arun Shinde |
| Designation |
Post-graduate student |
| Affiliation |
Manipal College Of Health Professions, MAHE, MAnipal |
| Address |
Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9594179869 |
| Fax |
|
| Email |
rahulshnd1022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry Kasturba Hospital, Manipal, Udupi |
|
|
Primary Sponsor
|
| Name |
Rahul Arun Shinde |
| Address |
Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal. |
| 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 |
| Rahul Arun Shinde |
Kasturba Hospital |
Department of Psychiatry, third floor
Udupi
KARNATAKA |
9594179869
rahulshnd1022@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, (2) ICD-10 Condition: F316||Bipolar disorder, current episodemixed, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals in the age group of 25-50 years.
2.English and Kannada speaking participants having formal education while obtaining inform consent
3.Minimum 2 years of mental illness diagnosed with Schizophrenia or bipolar disorder
|
|
| ExclusionCriteria |
| Details |
1.Participants who are not stable enough to give informed consent
2.Participants with acute stage
3. mental illness less than 2 years will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| World Health Organization Disability Assessment Scale and Global Physical Activity Questionnaire |
minimum 2 years of mental illness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2020 |
| Date of Study Completion (India) |
17/03/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
1) Title of the Project: : Association between Disability and Physical Activity Levels in Individuals with Serious Mental Illness. 2) Type of Study: Cross-sectional study, single-center study 3) Aim: To study the relation between disability and physical activity levels in individuals with serious mental illness. 4) Justification for the Study: As disability and decreased physical activity levels both lead to affected participation in day to day activities in individuals with serious mental illness, so there is a need to study whether there is an association between them. The study will help to understand whether physical activity levels are affected due to disability in people with severe mental illness in the Indian population and understanding the association will help the professionals to develop disability-based strategies to improve physical fitness, especially where research on related issues is limited. 5) Detailed description of Procedure/ Process: - To get approval from the Department Research Committee of Occupational Therapy followed by approval from the Institutional Research Committee, MCHP.
- · To get clearance from the Institutional Ethics Committee, KH and to register in Clinical Trial Registry India.
- · To get permission from the Psychiatry department of KH for recruitment of participants who are coming as an outpatient.
- · Translation and validation of a scale.
- · Clients with a diagnosis of Schizophrenia and Bipolar Mood Disorder will be selected based on inclusion and exclusion criteria.
- · These participants will be recruited from Psychiatry department of KH and also through medical record department, KH, manipal as per inclusion and exclusion criteria
- · Participants will be briefed on the study, and informed consent will be obtained by telephonic and face to face
- · The World Health Organization Disability Assessment Scale and Global Physical Activity Questionnaire will be administered telephonically and face to face on participants.
- · The data from the assessment will be then analyzed accordingly.
- · To write and submit a thesis.
|