Objectives: This study aimed to determine the effect of exercise on quality of life for women after childbirth . Design: This study is an international study in two groups (intervention and control groups) . Participants :The study population will be 80 randomly selected women who had normal vaginal delivery and 3 to 5 days after delivery will refer to health care centers in Hamadan city for routine maternal and infant health cares.Using a tale of random numbers, random sampling will done . First, from all health care centers in Hamadan city 4 health care centers will select randomly ( 2 health care centers for control group and 2 health care centers for intervention group). Then, from eligible women in each health care center 20 women will select randomly. With this way, Eighty postpartum women randomly will be selected in two control and intervention groups (40 in each group). Setting and conduct: In the first postpartum care after delivery (3 to 5 days after delivery) using a structured questionnaire include quality of life condition, exercise behavior and demographic characteristics data of women in two groups will be completed.Questionnaires will be completed by interviews with both groups of the study . Intervention: for intervention group, in addition to routine care in 3 to 5 days after delivery by a movie on postpartum exercises, women will be trained and encouraged to exercise extend educational booklets and CDs. Women will be recommended to do postpartum exercise up to 6 weeks twice a day for 10 to 15 minutes each day at home. This exercise should be performed at least 5 days a week. Control: during this period, the control group received only routine care. Main outcome measures are exercise and quality of life. Comparison of two groups will done in 3 to 5 days after delivery (postpartum care I), 10 to 14 days after delivery (postpartum care II) and 45 to 60 days after delivery (postpartum care III) in terms of exercise behavior and quality of life .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072310426N13
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of exercise on quality of life in postpartum women
Public title
The effect of exercise on quality of life in postpartum women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian citizenship; literacy; 1st to 3 rd Gravidity ; Delivery of term and healthy newborn; living with spouse; Age between18 to 35 years; Having singleton birth ; Normal vaginal delivery ; No symptoms with exercise limitation; lack of dystocia or problem in labor .
Exclusion criteria: Taking painkiller drugs; Having stress or family problems; Immigration of mother ; lack of exercise ; Hospital admission for newborn .
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park , Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.151
Health conditions studied
1
Description of health condition studied
Quality of life in postpatum
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Quality of life status in postpatum
Timepoint
3 to 5 days after delivery (Postpartum care I) , 10 to 14 days after delivery (postpartum care II) and 45 to 60 days after delivery (postpartum care III)
Method of measurement
SF-36 ( The Short Form -36) Quality of Life Questionnaire
Secondary outcomes
1
Description
Exercise status in postpatum
Timepoint
3 to 5 days after delivery (Postpartum care I) , 10 to 14 days after delivery (postpartum care II) and 45 to 60 days after delivery (postpartum care III)
Method of measurement
Behavioural Regulation in Exercise Questionnaire (BREQ)
Intervention groups
1
Description
Intervention group: After filling the consent form, in addition to routine care in 3 to 5 days after delivery by a movie on postpartum exercises, women will be trained and encouraged to exercise extend educational booklets and CDs. Women will be recommended to do postpartum exercise up to 6 weeks twice a day for 10 to 15 minutes each day at home. This exercise should be performed at least 5 days a week. This group will be evaluated in 3 to5 days after delivery (Postpartum care I), 10 to 14 days after delivery (postpartum care II) and 45 to 60 days after delivery (postpartum care III) terms of exercise and quality of life .
Category
Lifestyle
2
Description
Control group: only will receive routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Health Deputy of Hamadan Univrsity of Medical Sciences
Full name of responsible person
Banafsheh Boojarzadeh
Street address
Phalastin Square, Public Health Deputy of Hamadan Univrsity of Medical Sciences, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park , Hamadan University of Medical Sciences, Hamadan
City
Hamadan
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 Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Famideh Street , Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
Parsa@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)