| CTRI Number |
CTRI/2026/01/100667 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exercise in Schizophrenia: Can patients keep it up? |
|
Scientific Title of Study
|
The acceptance and adherence to a 40-minute daily exercise regime among patients with schizophrenia following a family assisted training received during their hospitalization period - An observational cohort 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 |
Dr K Hariini |
| Designation |
Psychiatry Resident |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi road,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9940618293 |
| Fax |
|
| Email |
dr.hariini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghuthaman G |
| Designation |
Professor and Guide |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi road,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9789459987 |
| Fax |
|
| Email |
raghuthaman_gopal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghuthaman G |
| Designation |
Professor and Guide |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi road,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9789459987 |
| Fax |
|
| Email |
raghuthaman_gopal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PSG Institute of Medical Sciences and Research,
P.O.Box no. 1674,
Peelamedu,
Coimbatore- 641004,
Tamilnadu,
India |
|
|
Primary Sponsor
|
| Name |
Dr K Hariini |
| Address |
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi road,
Peelamedu,
Coimbatore |
| 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 K Hariini |
PSG Institute of Medical Sciences and Research |
Room no. 2D,
A block,
Department of Psychiatry,
PSG Institute of Medical Sciences and Research,
Post Box 1674, Off Avinashi road,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU |
9940618293
dr.hariini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise program |
40-minute exercise program which includes brisk walking followed by exercise regime |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive hospitalized patients meeting the ICD (International Statistical Classification of Diseases and Related Health Problems) 11 criteria for Schizophrenia (6A20) |
|
| ExclusionCriteria |
| Details |
Patients with a comorbid clinical diagnosis of intellectual disability are excluded.
Patients who have comorbid physical conditions like myocardial infarction of less than 3 months duration, COPD limiting physical exertion, uncontrolled hypertension, orthopaedic limitations, are excluded from the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility and acceptance of the training programme. |
Baseline, 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to the training programme after discharge. |
Baseline, 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
16/02/2026 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to evaluate the acceptance and adherence to a 40 minute exercise regime among patients with schizophrenia after a family-assisted hospital training. A 40 minute exercise program is employed, which if performed daily results in improvement in physical flexibility and cardio endurance.
The primary objective is to determine the feasibility and acceptance of the family-assisted training programme among patients hospitalized for the management of schizophrenia to do exercise for 40 minutes every day. This study, furthermore, would evaluate the adherence to the 40 minute exercise regime at home for 4 weeks after discharge.
Patients and their respective caregivers will be trained in all the formulated exercises during their hospitalization period and caregivers will be trained to monitor and assist his/her patient in performing the exercises. |