To assess the effect of squat sport training versus no training on fatigue and quality of life in pregnant women
Design
This is a randomized clinical trial, in which 100 eligible pregnant women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women with fatigue who will refer to Comprehensive Health Centers in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the cluster randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 35 years
Second trimester
Singleton
Literate
Normal body mass index
Exclusion criteria:
Any pregnancy complications
Any background disease
Mental disorders
Musculoskeletal diseases
Intervention groups
Intervention group:
Routine pregnancy care plus squat sport training for 30 to 45 minutes daily for 8 days
Control group:
Just routine pregnancy care
Main outcome variables
Primary outcome:
Assessing the severity of fatigue
Secondary outcome:
Assessing the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N292
Registration date:2019-09-07, 1398/06/16
Registration timing:prospective
Last update:2019-09-07, 1398/06/16
Update count:0
Registration date
2019-09-07, 1398/06/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of squat sport training versus no training on fatigue and quality of life in pregnant women: a randomized clinical trial
Public title
Effect of squat sport training versus no training on fatigue and quality of life in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years
Second trimester
Singleton
Literate
Normal body mass index
Exclusion criteria:
Any pregnancy complications
Any background disease
Mental disorders
Musculoskeletal diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the pregnant women to the intervention and control groups by cluster randomization of the health centers. To do this, we will write the names of the Comprehensive Health Centers on the paper sheets and then assign each health center to one of the "intervention" or "control" groups through drawing a lot. Then, depending on to which center every pregnant woman refer, she will be assigned to the intervention or control groups.
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
IR.UMSHA.REC.1398.423
Health conditions studied
1
Description of health condition studied
Fatigue
ICD-10 code
O26.812
ICD-10 code description
Pregnancy related exhaustion and fatigue, second trimester
Primary outcomes
1
Description
Assessing the severity of fatigue
Timepoint
Before the intervention and 8 days after that
Method of measurement
Using multidimensional Fatigue Index (MFI)
Secondary outcomes
1
Description
Assessing the quality of life
Timepoint
Before the intervention and 8 days after that
Method of measurement
Using standard SF-36 questionnaire
Intervention groups
1
Description
Intervention group: Routine pregnancy care plus squat sport training for 30 to 45 minutes daily for 8 days, including shoulder width squats, open leg squats, closed leg squats, staggered squats, single leg squats, side buttock squats, full squats, sitting squats, and ball squats. At the beginning of each session for 10 minutes are devoted to warming up and at the end of sessions 10 minutes are devoted and cooling down. The workouts will start with low numbers and sets, and then in the next sessions and better physical fitness, the intensity and number of workouts will be increased.
Category
Treatment - Other
2
Description
Control group: Just routine pregnancy care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan City
Full name of responsible person
Maryam Malmir
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryam.malmir69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Malmir
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryam.malmir69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedh Zahra Masoomi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001 @yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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