The purpose of this study was to compare the effects of interval training and vitamin D on the Pre-Menstrual Syndrome in non-athletic girls. Designing: This experimental study was conducted on 45 non-athlete female students. They were at the age of 18-23 years old and had been diagnosed with PMS. Participants were randomly divided into two experimental groups (vitamin D, education) and a control group through coin toss. Interventions were as following; Intervention group 1: interval training was performed during 6 weeks and there were 3 sessions of training in every week and each session lasted 45 minutes. Intervention group 2: Students in other group were advised to use the vitamin D (1000IU), 1 time a day for a 6 weeks. Control group: students in this group didn’t use any exercise or drug. The main outcomes of this study – physical symptoms and mood and behavioral symptoms- were investigated using premenstrual symptoms screening tool (psst).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080420465N5
Registration date:2017-04-21, 1396/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Fatemeh Omidali
Name of organization / entity
University of Ayatollah Boroujerdi
Country
Iran (Islamic Republic of)
Phone
+98 66 4246 8320
Email address
f.omidali@abru.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Ayatollah Boroujerdi
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of interval training and vitamin D on symptoms of premenstrual syndrome in non-athlete females
Public title
The effects of interval training and vitamin D on symptoms of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PMS symptoms; not being under medical treatment; non-athletes. Exclusion criteria: being affected with any type of disease; lack of cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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 University of Ayatollah Boroujerdi
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Postal code
167
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
93-پ10
2
Ethics committee
Name of ethics committee
Ethics committee of University of Ayatollah Boroujerdi
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Postal code
167
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
93-پ10
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome (PMS)
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
physical symptoms
Timepoint
At the begining and at the end of the study
Method of measurement
Premenstrual Symptoms screening tool (PSST), Iranian version
2
Description
mood and behavioral symptoms
Timepoint
At the begining and at the end of the study
Method of measurement
Premenstrual Symptoms screening tool (PSST), Iranian version
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: interval training, 45 minutes in each session, 3 times a week, for 6 weeks.
Category
Lifestyle
2
Description
Intervention group 2: oral vitamin D, 1000 IU, 1 time a day, for 6 weeks.
Category
Treatment - Drugs
3
Description
Control group: not done any exercise and do not use drugs
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Bourujerdy University
Full name of responsible person
Fatemeh Omidali
Street address
City
Bourujerd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ayatolah Bourujerdy University
Full name of responsible person
Fatemeh Omidali
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ayatolah Bourujerdy University
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
Ayatolah Bourujerdy University
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Postal code
167
Phone
+98 66 4246 8320
Fax
Email
omidali.fatemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ayatolah Bourujerdy University
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Postal code
Phone
+98 66 4246 8320
Fax
Email
omidali.fatemeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ayatolah Bourujerdy University
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3th kilometer of Khorramabad road
City
Bourujerd
Postal code
Phone
+66 42 468 320
Fax
Email
omidali.fatemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)