Objective: We studied the effect of adding exercise and regular physical activity on usual treatments of MDD . Method: 46 depressed patients according to DSM-5 criteria from Roozbeh hospital ward and outpatient clinics were selected to conduct Interventional clinical trial based on inclusion and exclusion criteria and after obtaining written consents, were divided randomly into two equal groups. At the beginning of the plan, two people from the control group and two people from the sample group were excluded due to non-compliance with the terms of the plan and then a group of sample including 21 people received only the usual drug treatment and a group of control including 21 people received the drug treatment plus exercise (according to protocol) both for 8 weeks. The general conditions for acceptance of patients with MDD were between the ages of 18 to 64 years. Exclusion criterias were major acute, chronic medical illness and acute , chronic psychiatric illness except MDD ,and acute suicidal ideations and substance abuse disorders .
Patients before the intervention and at the end, were checked with the physical and medical profiles and quality of life and general health by questionnaire. At the beginning and end of the study, patients evaluated by depression and anxiety beck & Hamilton tests and PITT test was carried out for sleep quality and Results were analyzed by SPSS 20 instruments that, the quality and Results were analyzed that, the main Consequence was depression and Secondary Consequences were anxiety, sleep, medical profile and body mass index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111630924N1
Registration date:2017-01-19, 1395/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-19, 1395/10/30
Registrant information
Name
ُُSeyyed Azim Seyd
Name of organization / entity
Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 6663 3114
Email address
mokriazr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adjunctive exercise in patients with major depressive disorder(MDD) receiving routine pharmacotherapy
Public title
Effects of exercise in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion: Major acute and cronic Medical illness psychiatric disorders except Major Depressive Disorder ,and acute suicidal ideations and substance abuse disorders.
Inclusion: Patients with Major Depressive Disorder; Age between 18 to 64 Years
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of randomizing: Table of random numbers
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Tehran university of medical sciences , enghelab street
City
Tehran
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.Tums.REC.1394.1194
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32 : F32
ICD-10 code description
Depressive episode ; Mild depressive episode with and without somatic symptoms,Moderate depressive episode with and without somatic symptoms,Sever depressive episode without psychotic symptoms,Recurrent depressive disorder current episode mild,Recurrent d
Primary outcomes
1
Description
Major depressive disorder
Timepoint
Beginning and end of Exercise plan (Baseline and 8 weeks later)
Method of measurement
Interview, questionaire, laboratory tests
Secondary outcomes
1
Description
Sleep
Timepoint
Onset and end of exercise plan
Method of measurement
Sleep questionnaire of pitseburg
2
Description
Anxiety
Timepoint
Onset and final of exercise plan
Method of measurement
Interview, anxiety Questionnaires of beck and hamilton
3
Description
General health and qualithy of life
Timepoint
Onset and end of exercise plan
Method of measurement
General Heaith and Qualithy of life questionnaire
4
Description
medical profile
Timepoint
Onset and end of exercise plan
Method of measurement
laboratory tests
5
Description
Body mass index
Timepoint
Onset and end of exercise plan
Method of measurement
Scale to weith
Intervention groups
1
Description
Control group: In this group only treated with pharmacotherapy equal interventional pharmacotherapy namely specific serotonin reuptake inhibitor antidepressants treated.
Category
Behavior
2
Description
Interventional group : Randomized Clinical trail 8 weeks adjunctive exercisetherapy with kind of airobic plus light strength three times a week per part 45 minutes aded to routin pharmacotherapy treatment evaluated for MDD in intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr Seyyed Azim Seyd
Street address
Roozbeh hospital , South karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Science
Full name of responsible person
Mrs Ahmadi
Street address
Vice chancellor for research of Tehran University of Medical science , Intersection ghods St. , Enghelab St.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Roozbeh hospital research center
Full name of responsible person
Dr seyed azim seyd
Position
Psychiatrist
Other areas of specialty/work
Street address
Roozbeh Hospital , south karegar St.
City
Tehran
Postal code
Phone
+98 21 5540 9051
Fax
Email
draliseyd@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Roozbeh Hospital research center
Full name of responsible person
Dr Seyed Azim Seyd
Position
Psychiatrist
Other areas of specialty/work
Street address
Roozbeh hospital , South karegar St.
City
Terhran
Postal code
Phone
+98 21 5540 9051
Fax
Email
draliseyd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Roozbeh hospital research center
Full name of responsible person
Dr Seyyed Azim Seyd
Position
Psychiatrist
Other areas of specialty/work
Street address
Roozbeh hospital research center , south karegar St.
City
Tehran
Postal code
Phone
+98 21 5540 5051
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)