| CTRI Number |
CTRI/2017/03/007976 [Registered on: 01/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Aerobic Exercises on Depression Patients |
|
Scientific Title of Study
|
Effectiveness of Aerobic Exercises on Depressive symptoms,Anxiety,Self esteem and Quality of Life among Adults with Depression Attending Outpatient Services at Selected Psychiatric Hospitals,Raipur District. |
| Trial Acronym |
AED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UDATHA TIRUPATHI RAO |
| Designation |
MPHIL NURSING SECOND YEAR |
| Affiliation |
POST GRADUATE INSTITUTE OF BEHAVIOURAL AND MEDICAL SCIENCES |
| Address |
MANIPAL COLLEGE OF NURSING
MANIPAL UNIVERSITY
MANIPAL
PRATHIBA INSTITUTE OF NURSING
DALDALSEONI ROAD MOWA
RAIPUR CHHATTISHGARH
PIN 492001
Udupi
KARNATAKA
576104
India |
| Phone |
9603390984 |
| Fax |
|
| Email |
raosvims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJudith Angelitta Noronha |
| Designation |
Associate Dean and Professor |
| Affiliation |
Manipal College of Nursing,Manipal |
| Address |
Manipal College of Nursing
Manipal University
Manipal Udupi district
Karnataka India
Manipal College of Nursing
Manipal University
Manipal Udupi district
Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9448506594 |
| Fax |
|
| Email |
judith.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
UDATHA TIRUPATHI RAO |
| Designation |
MPHIL NURSING SECOND YEAR |
| Affiliation |
POSTGRADUATE INSTITUTE OF BEHAVIOURAL AND MEDICAL SCIENCES |
| Address |
MANIPAL COLLEGE OF NURSING
MANIPAL UNIVERSITY
MANIPAL
PRATHIBA INSTITUTE OF NURSING
DALDALSEONI ROAD MOWA
RAIPUR CHHATTISHGARH
PIN 492001
Udupi
KARNATAKA
576104
India |
| Phone |
9603390984 |
| Fax |
|
| Email |
raosvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANOPACHAR,
POST GRADUATE INSTITUTE OF BEHAVIOURAL AND MEDICAL SCIENCES
Opp. Rajkumar College, Swami Atmanand Marg, G. E. Road,
Raipur-492001, Chhatisgarh India. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
NA |
| Type of Sponsor |
Other [There is no sponsor] |
|
|
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 PRAKASH NARAYAN SHUKLA |
Manopachar |
MANOPACHAR
POST GRADUATE INSTITUTE OF BEHAVIOURAL AND MEDICAL SCIENCES
Opp. Rajkumar College, Swami Atmanand Marg, G. E. Road,
Raipur-492001, Chhatisgarh India.
Raipur
CHHATTISGARH |
9424210123
manopchar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee |
Approved |
| Institutional Ethics Committee Kusturba Hospital Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with depression, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercises |
The aerobic exercises are thee types encompassed into intervention
1.walking duration 10 min
2.stair climbing duration 5 min
3. aerobic dance 20 minutes
a.These all have the warm up and cool down between exercise.
b.The planned intervention duration is 35 minutes(One session).
c.One session in a day and per week 3 sessions only.
d.The patients have to attend the 8 weeks (24 sessions)consecutively. |
| Comparator Agent |
Aerobic exercises and Standard medications |
patients receiving standard medications along aerobic exercises and patients receiving the standard medications. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. adults with depression attending outpatient services at
selected psychiatric hospitals Raipur
2. Patients speaks English and Hindi
3. Patients who are present at the time of data collection
4. Patients who are willing to participate in the study
5. Both male and female patients.
6. Patients who receives the same treatment regimen.
|
|
| ExclusionCriteria |
| Details |
1. Patients unable to perform physical activity due medical problems.
2. Patients who are already practicing aerobic exercises
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease the depressive symptoms, anxiety,and improves self-esteem and quality of life. |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depressive patients reduce the depression,anxiety and improves the self esteem, quality of life. |
5 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/01/2017 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a quasi experimental ,single centre trail comparing the aerobic exercises and standard medication among 80 patients diagnosed with depression. the primary outcome measures are the depressive symptoms,anxiety,self esteem and quality of life improves the 5 months and sustains long time. |