The Effect of pregnancy period sport exercises on the Prevention of Fatigue and Depression in Mothers
Design
The clinical trial has a community-based, practice-oriented control group, with parallel groups, randomized
Settings and conduct
Health Centers of Imam Jafar Sadegh and Abuzar Ghaffari Zahedan City. Parallel, Randomized
Participants/Inclusion and exclusion criteria
entry conditions:
pregnant women had no complaint of depression and fatigue before the study.
gestational age of 16 to 20 weeks, having alive and healthy infant, singleton pregnancy, adequate education to read and write.
non entry conditions: cardiovascular diseases, health conditions in pregnancy that are prohibited from exercise_ as major anemia, diabetes, airway inflammation, being severely underweight or overweight, hypertension and hyperthyroidism.
Intervention groups
the intervention group was under the prenatal exercise program according to the instructions of clapp et al.The exercise protocol, was adjusted and performed for at least 30 to 45 minutes, 3 days a week for 8 weeks.Unlike the test group,for the control group did not recommend a specific training program.
Main outcome variables
The state of fatigue and depression of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N1
Registration date:2018-10-28, 1397/08/06
Registration timing:retrospective
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2015-12-20, 1394/09/29
Trial completion date
2015-12-20, 1394/09/29
Scientific title
The Effect of pregnancy period sport exercises on the Prevention of Fatigue and Depression in Mothers
Public title
The Effect of pregnancy period sport exercises on the Prevention of Fatigue and Depression in Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a gestational age of 16 to 20 weeks (in consultation with a gynecologist)
having a live and healthy embryo
having singleton pregnancy
having a reading and writing education
Exclusion criteria:
cardiovascular disease
musculoskeletal disorders
Diseases that prohibited exercise in pregnancy such as severe anemia, diabetes, respiratory infections, obesity or severe weight loss, hypertention and hyperthyroidism
history of abortion
signs of preterm labor
Having placenta previa or vaginal bleeding or any symptoms of abortion
high risk pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, packed envelope (by selecting the envelope containing No. 1 patient in the intervention group and by selecting the envelope containing the number 2 patient in the control group)
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
Kerman University of Medical Sciences
Street address
Campus of Kerman University of Medical Sciences, Beginning of the Axis of Alavi Gardens, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2015-08-17, 1394/05/26
Ethics committee reference number
Ir.kmu.rec.1394.526
Health conditions studied
1
Description of health condition studied
Exercise during pregnancy, fatigue, depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression of Pregnant Mothers
Timepoint
Before intervention and immediately after intervention
Method of measurement
Beck2 Depression Inventory
2
Description
Fatigue of pregnant mothers
Timepoint
Before intervention and immediately after intervention
Method of measurement
A multidimensional log of fatigue-short form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group was under the prenatal exercise program according to the instructions of clapp et al. The exercise protocol, including warm up, tensile training, flexibility, followed by continuous aerobic walking, all of which focused on the training of pregnant women, was adjusted and performed for at least 30 to 45 minutes, 3 days a week for 8 weeks. The upper and lower parts of the body were exercised for 15 minutes followed by aerobic exercises, including continuous walking, which included 5 minutes of gentle walking in the first session and then increasing one minute to the training time in each session until reaching 15 minutes, from then until the end of the 24 sessions of practice, the activity time was kept constant and in order to go back to the initial state and cool the body from tensile stretches in sitting position for 10 to 15 minutes until the heart rate of the subjects reaches to less than 100 beats per minute. In order to prevent any potential physical problems, the intensity of exercise was 60% of the maximum heart rate per person and heart rate counting 3 times by carotid pulse controlled by the investigator (1). Aerobic exercises were conducted under the supervision of an expert in physical education, midwifery expert and researcher. During the exercises and back to the initial state, with the aim of not feeling tired and optimizing the training environment, soft music was used and after exercise in each session, all subjects used liquids such as water or juice.
Category
Rehabilitation
2
Description
Control group: Unlike the test group, all of whom participated in the exercise according to the program, the control group did not recommend a specific training program and emphasized that they should report if they do regular exercises during the study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Jafar Sadegh Center of Zahedan
Full name of responsible person
Shokoufeh Mogharabi Ostad Kalayeh
Street address
Zibashahr, Nasr Street 13, Velayat 1 Alley
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817978761
Phone
+98 54 3343 1227
Email
sh.mogharabi71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Samari
Street address
Campus of Kerman University of Medical Sciences, Beginning of the Axis of Alavi Gardens, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5803
Email
sh.mogharabi71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Islamic Azad University
Full name of responsible person
Shokoufeh Mogharabi Ostad Kalayeh
Position
science Committee, Director of Nursing Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Velayat 1 Alley, Nasr Street 13, Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817978761
Phone
+98 54 3343 1227
Email
sh.mogharabi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shokoufeh Mogharabi Ostad Kalayeh
Position
science Committee, Director of Nursing Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Velayat 1 Alley, Nasr Street 13, Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817978761
Phone
+98 54 3343 1227
Email
sh.mogharabi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shokoufeh Mogharabi Ostad Kalayeh
Position
science Committee, Director of Nursing Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Velayat 1 Alley, Nasr Street 13, Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817978761
Phone
+98 54 3343 1227
Email
sh.mogharabi71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD