The purpose of this randomized controlled clinical trial is to determine the effect of exercise on the postpartum depression and postpartum fatigue. 126 pregnant clients with an alive fetus and gestational age of 26-32 weeks will be chosen in selected health centers. The women should have the Edinburgh score less than 15 and have no contraindications for performing exercise. Women will randomly be allocated in one of three groups. A (control): in this group women will get prenatal and postpartum ordinary educations in 3 sessions (each session takes 15-20 minutes). B (prenatal exercise): in this group women after getting one session of theoretical and practical education about prenatal exercise (30-40 min) will exercise 3 times a week according to the CD (the materials of this CD was approved by ministry of health and medical education). C (prenatal and postpartum exercise): women in this group in addition to getting education and doing prenatal exercise will do postpartum exercise in 4 first weeks if they can and then 3 times a week according to the postpartum exercise CD. We will phone B and C group women monthly for follow up. The self-administered questionnaires (Edinburgh and fatigue identification form) will be filled by the women before intervention, then 4 and 8 weeks after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008193706N5
Registration date:2010-11-20, 1389/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-20, 1389/08/29
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-04-19, 1390/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exercise on postnatal depression and fatigue in clients of health centers: A randomized controlled clinical trial
Public title
Effect of exercise on postpartum depression and postpartum fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with 26-32 weeks of gestational age and with an alive fetus; 6 years or over education; not currently suffering from disease that would limit exercise (cardiopulmonary, musculoskeletal,...); not currently taking medication that interferes with heart rate response to exercise - no history of threaded to abortion in present pregnancy - no signs of preterm labor in present pregnancy; not having the placenta previa in present pregnancy; nonexistence of fetal malformations; score of less than 15 on the Edinburgh scale; no history of medication and hospitalization for a psychiatric disorder in the past 6 months; not currently participating in regular high tensity exercise (60 min or more in a week); having the CD-player set or computer and knowing how to use it. Exclusion criteria: obstetric or concomitant disease which would have preclude participation in an exercise program; any condition that would make exercise unsafe or unwise (vaginal bleeding, rupture of membrane, palpitation, dyspnea,....); occurring the fetal or infant death during the study; confirmed fetal malformations.
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy, Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2010-10-14, 1389/07/22
Ethics committee reference number
8934
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F32
ICD-10 code description
deppressive episode
Primary outcomes
1
Description
postpartum depression
Timepoint
1) befor intervention, 2) 4 and 8 weeks after birth
Method of measurement
Edinburgh scale
Secondary outcomes
1
Description
potpartum fatigue
Timepoint
1)before intervention, 2) 4 and 8 weeks after birth
Method of measurement
fatigue identification form
Intervention groups
1
Description
C (prenatal and postpartum exercise): women in this group in addition to getting education and doing prenatal exercise will do postpartum exercise in 4 first weeks if they can and then 3 times a week according to the postpartum exercise CD.
Category
Other
2
Description
B (prenatal exercise): in this group women after getting one session of theoretical and practical education about prenatal exercise (30-40 min) will exercise 3 times a week according to the CD (the materials of this CD was approved by ministry of health and medical education).
Category
Other
3
Description
A (control): in this group women will get prenatal and postpartum ordinary educations in 3 sessions (each session takes 15-20 minutes).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Health Post
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Shahidan Ebrahimi Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
3
Recruitment center
Name of recruitment center
Emamieh Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
4
Recruitment center
Name of recruitment center
Seyyed Bavafa Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
5
Recruitment center
Name of recruitment center
Gomtapeh Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
Tabriz
City
east Azarbijan
6
Recruitment center
Name of recruitment center
Azadi Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
7
Recruitment center
Name of recruitment center
Mojahedin Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
8
Recruitment center
Name of recruitment center
Aboutaleb Health Post
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
9
Recruitment center
Name of recruitment center
Sayyad Shirazi Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
10
Recruitment center
Name of recruitment center
Montazeri Health Post
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
11
Recruitment center
Name of recruitment center
Molla Hassan Health Center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
12
Recruitment center
Name of recruitment center
Gorbani Health Post
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
13
Recruitment center
Name of recruitment center
Ashrafi Laleh Health center
Full name of responsible person
Mohammadi-Fatemeh - master student of midwifery
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz university of medical sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz university of medical sciences
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
Tabriz university of medical sciences
Full name of responsible person
Mohammadi Fatemeh
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1332 2127
Fax
+98 41 1479 6969
Email
f.mohammadi87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
Assistant professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir smoalch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mohammadi Fatemeh
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1332 2127
Fax
+98 41 1479 6969
Email
f.mohammadi87@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)