Protocol summary

Summary
The postpartum period is transition to critical stage and the rapid changes that are experienced postpartum therefore mother being exposed to unpleasant experiences of fatigue and changes in sleep pattern. exercise training are effective methods in postpartum period lead to accelerate recovery and achieve higher level of health in mothers. The purpose of this study is to determine the effect exercise training on fatigue and sleep quality of mothers in the postpartum period. The study is randomize clinical trial; mothers randomly assigned to two groups(40 exercise and 40 control); pilates exercise perform five sessions per week for eight weeks in mothers intervention group, starting exercise is rather 36 hours after delivery and until first week after birth;control group will not received intervention.fatigue and sleep quality measurement in the begining of study (37 weeks of pregnancy), 24 hours after delivery and first four weeks and two four weeks postpartum

General information

Acronym
Exercise
IRCT registration information
IRCT registration number: IRCT201102275912N2
Registration date: 2011-12-30, 1390/10/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-30, 1390/10/09
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of effect exercise on fatigue and sleep quality mothers in postpartum
Public title
Effect of exercise on fatigue and sleep quality mothers in postpartum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Inclusion criteria: Iranian born, Age Range 18-35, At least the end of primary education, Primiparous, Absence of any disease, acute and chronic physical and mental, Healthy Infant ,Exclusive Breast feeding, Access to computer or VCD device for watch video, Exclusion criteria : postpartum depression, forget consecutive three sessions or withdrawal five sessions of exercise, Appearing any medical or obstetric that inconsistent with the exercise, Life shift or migrate to other cities during the study, Infant Hospitalization any reason, Diagnosis of postpartum anemia
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: 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
Tehran University of Medical Siences and Health Services
Street address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences, 6th floor
City
Tehran
Postal code
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
1949/130/ص/89

Health conditions studied

1

Description of health condition studied
Fatigue and Sleep Quality
ICD-10 code
094,099
ICD-10 code description
Other Obstetric Conditions, Not elsewhere classified

Primary outcomes

1

Description
Fatigue (General Fatigue, Physical Fatigue, Mental Fatigue, Reduce Activity, Reduce Motivition)
Timepoint
24 hour after delivery, four weeks postpartum, eight weeks postpartum
Method of measurement
Multidimensional Fatigue Inventory

2

Description
Sleep quality( subjective Sleep quality,Sleep latency,Sleep duration,Sleep efficiency, Sleep disturbance, Sleep medication
Timepoint
24 hour after delivery, four weeks postpartum, eight weeks postpartum
Method of measurement
Pittsburgh Sleep Quality

Secondary outcomes

empty

Intervention groups

1

Description
Control group except usual activities of daily do'nt perform intervention and throughout the study will be supervised.
Category
Treatment - Drugs

2

Description
Intervention group will be perform pilates exercise preferably consecutive 5 sessions per week to time 30 min for eight weeks
Category
Treatment - Drugs

3

Description
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
One urban Health center
Full name of responsible person
farzaneh ashrafinia, postgraduate student
Street address
Emam Street, Rafsanjan
City
Rafsanjan

2

Recruitment center
Name of recruitment center
Two urban Health center
Full name of responsible person
farzaneh ashrafinia, post graduate student
Street address
15 Khordad street, Rafsanjan
City
Rafsanjan

3

Recruitment center
Name of recruitment center
Three urban Health center
Full name of responsible person
farzaneh ashrafinia postgraduate student
Street address
Mirafzali street
City
Rafsanjan

4

Recruitment center
Name of recruitment center
Four urban Health center
Full name of responsible person
farzaneh ashrafinia post graduate student
Street address
West Amirkabir street
City
Rafsanjan

5

Recruitment center
Name of recruitment center
Five urban Health center
Full name of responsible person
Farzaneh ashrafinia , post graduate student
Street address
Kargar street, Rafsanjan
City
Rafsanjan

6

Recruitment center
Name of recruitment center
Six urban Health center
Full name of responsible person
farzaneh ashrafinia, postgraduate student
Street address
Amir kabir street, Rafsanjan
City
Rafsanjan

7

Recruitment center
Name of recruitment center
Seven urban Health center
Full name of responsible person
farzaneh ashrafinia, postgraduate student
Street address
West Amir kabir, Rafsanjan
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Tehran University of Medical Sciences
Full name of responsible person
Abbas Hoshmand Behabadi
Street address
Faculty of Nursing and Midwifery, Nosrat ST,Tohid SQ
City
TEhran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Tehran 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
Tehran University of Medical Scinces
Full name of responsible person
Mandana Mir Mohammad Ali Ei
Position
Scientific Instructor
Other areas of specialty/work
Street address
Tehran
City
Faculty of Nursing and Midwifery, Nosrat ST, Tohid Sq
Postal code
00989123906609
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
mirmohammad@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of physical Education of Teacher training University
Full name of responsible person
Hamid Rajabi
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of physical Education of Teacher training University, Mirdamad St
City
Tehran
Postal code
Phone
+98 21 2226 9545
Fax
Email
hrajabi@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Farzaneh Ashrafi Nia
Position
Graduate Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Nosrat St,Tohid Sq
City
Tehran
Postal code
Phone
Fax
Email
ashrafifarzaneh60@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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