The aim of study was to investigate the effect of exercise on depression and anxiety scores and sleep quality of middle aged patients with major depressive disorders.
Design
This study is designed as a randomized clinical trial with blinded outcome assessor with two parallel arms having an allocation ratio of 1:1. The minimum number of patients required for the study in each group was 15. Participants were randomly assigned to either control or study group with a 1:1 allocation ratio by TENALEA, which is an online, central randomization service using permuted blocks of random sizes.
Settings and conduct
Patients were assigned to the study voluntarily and were informed about the study using notifications in outpatient clinics and a briefing by the researchers in ‘’Roozbeh Hospital clinic‘’.
Since exercise is an overt behavior, there was not the possibility of blinding the participants and care providers. Thus, only those assessing outcomes were blinded.
Participants/Inclusion and exclusion criteria
The candidates were diagnosed with major depression on sertraline. Exclusion criteria were defined as: psychosis; suicidal actions or thoughts; self-mutilation; chronic diseases associated with vital organs such as heart, lungs, and kidneys; and bone and soft tissue disorders which made it impossible to comply with the exercise schedule.
Intervention groups
The study group received sertraline plus regular supervised exercise, 60 minutes a session, three times a week for a total duration of 8 weeks. The control group received only sertraline for 8 weeks.
Main outcome variables
Depression score in Beck depression inventory; Depression score in Hamilton depression scale; Anxiety score in Hamilton anxiety scale;Anxiety score in Beck anxiety inventory; Sleep quality index in Pittsburg sleep quality index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180506039542N1
Registration date:2018-06-29, 1397/04/08
Registration timing:retrospective
Last update:2018-06-29, 1397/04/08
Update count:0
Registration date
2018-06-29, 1397/04/08
Registrant information
Name
Bita Tavana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
b-tavana@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
2015-05-14, 1394/02/24
Actual recruitment end date
2016-04-18, 1395/01/30
Trial completion date
empty
Scientific title
Can exercise enhance the positive effects of sertraline in patients with major depressive disorders? A randomized clinical trial
Public title
Effects of exercise in major depression disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients were diagnosed with major depression based on DSM-V criteria
All the patients were on sertraline prior to study
Patients were healthy and were able to execute regular exercise
Exclusion criteria:
Patients who had psychosis
Patients who had suicidal actions or thoughts
Patients who had self-mutilation
Patients who had chronic diseases associated with vital organs such as heart, lungs, and kidneys
Patients who had bone and soft tissue disorders which made it impossible to comply with the exercise schedule
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to either control or study group with a 1:1 allocation ratio by TENALEA, which is an online, central randomization service using permuted blocks of random sizes.
In order to confirm allocation concealment, the randomization code was not released by the service until the patient had been enrolled in the study, which happened after all baseline measurements have been completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since exercise is an overt behavior, there was not the possibility of blinding the participants and care providers. Thus, only those assessing outcomes were blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, 6th floor, Central Building of Tehran Universtiy of Medical Sciences, Corner of Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2015-05-03, 1394/02/13
Ethics committee reference number
IR.TUMS.REC.1394.1194
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
V
ICD-10 code description
Mental and behavioral disorders
Primary outcomes
1
Description
Depression score in Hamilton depression scale
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
Hamilton depression scale
2
Description
Depression scores in Beck depression inventory
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
Beck depression inventory
3
Description
Anxiety scores in Hamilton anxiety scale
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
Hamilton anxiety scale
4
Description
Anxiety scores in Beck anxiety inventory
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
Beck anxiety inventory
5
Description
Sleep quality index in Pittsburg sleep quality index
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
Pittsburg sleep quality index
Secondary outcomes
1
Description
Body mass index
Timepoint
At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise
Method of measurement
The body weight (kilograms) divided by the square of the body height (square meters)
Intervention groups
1
Description
Control group: The control group were patients diagnosed with major depression on sertraline prior to this study with a dosage range of 50 to 150 mg daily. They continued to receive sertraline for 8 weeks (during the study).
Category
Treatment - Drugs
2
Description
Intervention group: Patients assigned to the test group were asked to perform regular exercises, 60 minutes a session, three times a week, under the supervision of a registered trainer for a total duration of 8 weeks. Physical activity was scheduled as aerobic, stretching and strengthening exercises. Patients were asked to do 15 minutes of warm up, and 40 minutes of stretching and strengthening exercises followed by 5 minutes of cooling down with low intensity activities. Patients enrolled in the test group received sertraline prior to this study with a dosage range of 50 to 150 mg daily which continued during the study.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr Azarakhsh Mokri
Street address
No. 606, South Karegar St., District 11, Roozbeh Hospital
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
b-tavana@farabi.tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Vice Chancellor for Research and Technology, 6th floor, Central Building of Tehran Universtiy of Medical Sciences, Corner of Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 6670 6141
Fax
+98 21 6670 6141
Email
msahrai@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Tavana
Position
General physician, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No.7, Jalal-e-Al-e-Ahmad Highway. Sports and Exercise Research Center, the Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
b-tavana@farabi.tums.ac.ir
Web page address
http://ni.tums.ac.ir/smrc/fa/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Tavana
Position
General physician, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No.7, Jalal-e-Al-e-Ahmad Highway. Sports and Exercise Research Center, the Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
b-tavana@farabi.tums.ac.ir
Web page address
http://ni.tums.ac.ir/smrc/fa/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Tavana
Position
General physician, researcher
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No.7, Jalal-e-Al-e-Ahmad Highway. Sports and Exercise Research Center, the Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
b-tavana@farabi.tums.ac.ir
Web page address
http://ni.tums.ac.ir/smrc/fa/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available