Protocol summary

Summary
Objectives: The aim of this study is to investigate the effect of Pilates and aerobic exercise on sleep quality and fatigue of female students in residence Method: This study is a semi -experimental and interventional study. Sample includes 120 female students aged 18 to 26 years selected from three residences (Pilates, aerobic exercise and control group). Inclusion criteria include single, Iranian and healthy girls whose their general health were validated before coming to study, aged 18 to 26 years, no history of any regularly physical activities for last 6 months, Body mass index 19/8 to 26, lack of misuse the drug, lack of stressful experiences during the last 3 months. Exclusion criteria include lack of training for three continuous or five non-continuous sessions, lack of tendency to continue cooperation, use of effective foods for sleeping and fatigue such as coffee, espresso and energetic drinks, the occurrence of stressful experiences during the study. Interventions: Pilates exercise will be done for 8 weeks. Sample will exercise in the presence of an instructor and researcher 60 minutes per time, 3 times per week for 8 weeks and aerobic exercise will be done for 8 weeks too. Sample will exercise in the presence of an instructor and researcher 60 minutes per time, 3 times per week for 8 weeks. The control group continued their daily activities. The main outcome variables: Petersburg Quality of Sleep and Fatigue questionnaires will be completed 4 and 8 weeks after beginning intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412282324N15
Registration date: 2015-06-02, 1394/03/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pilates and Aerobic Exercise on Quality of Sleep and Fatigue of Girl Students of Dormitory
Public title
Pilates and Aerobic Exercise and Quality of Sleep and Fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include single, Iranian and healthy girls whose their general health are validated before coming to study, aged 18 to 26 years, no history of any regularly physical activities for last 6 months, Body mass index 19/8 to 26, lack of misuse the drug, lack of stressful experiences during the last 3 months. Exclusion criteria include Lack of training for three continuous or five non-continuous sessions, lack of tendency to continue cooperation, use of effective foods for sleeping and fatigue such as coffee, espresso and energetic drinks, use of effective non-medical methods for fatigue and quality of sleep such as acupressure, use of effective psychiatric drugs for fatigue and quality of sleep during the study such as Floxetine and Citalopram, the occurrence of stressful experiences during the study, marriage during the study.
Age
From 18 years old to 26 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
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
Ethical Commitment of Iran University of Medical Sciences
Street address
Hemat Highway
City
Tehran
Postal code
Approval date
2015-04-06, 1394/01/17
Ethics committee reference number
110427

Health conditions studied

1

Description of health condition studied
Quality of Sleep
ICD-10 code
F51.9
ICD-10 code description
Nonorganic sleep disorder, unspecified

2

Description of health condition studied
Fatigue
ICD-10 code
F48.0
ICD-10 code description
Fatigue Psychogenic (general)

Primary outcomes

1

Description
Quality of Sleep
Timepoint
Before the Intervention, 4 and 8 weeks after Intervention
Method of measurement
Pittsburg Quality of Sleep Inventory

Secondary outcomes

1

Description
Fatigue
Timepoint
Before the Intervention,4 and, 8 weeks after Intervention
Method of measurement
MFI Fatigue Inventory

Intervention groups

1

Description
The control group continued their daily activities.
Category
Prevention

2

Description
The intervention group 1: Pilates exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention.
Category
Prevention

3

Description
The intervention group 2: Aerobic Exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaghayegh Femal Dorm
Full name of responsible person
Keshavarz Maryam
Street address
Nomber of 27, Opposite of Torkamanestan St, Motahari St.
City
Tehran

2

Recruitment center
Name of recruitment center
Amol Femal Dorm
Full name of responsible person
Keshavarz Maryam
Street address
Nomber of 138, Amol St, Opposite of Pasargad Hospital, Shariati St.
City
Tehran

3

Recruitment center
Name of recruitment center
Golestan Femal dorm
Full name of responsible person
Keshavarz Maryam
Street address
School of Rehabilitationl, Shahnazari St, Madar Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Ali Javad Moosavi
Street address
Hemat Highway
City
Tehran
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, Iran 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
School Nursing and Midwifery
Full name of responsible person
Ezzati Mosleh Maryam
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Rashid Yasemi St,Vliasr St
City
Tehran
Postal code
Phone
+98 81 3825 4708
Fax
Email
aryai0812@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Keshavarz Maryam
Position
Assistant Professor in Midwifery Education
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Rashid Yasemi St,Valiasr St.
City
Tehran
Postal code
Phone
00
Fax
Email
Keshavarz.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Keshavarz Maryam
Position
Assistant Professor in Midwifery Education
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Rashid Yasemi St,Vliasr St.
City
Tehran
Postal code
Phone
00
Fax
Email
Keshavarz.m@iums.ac.ir
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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