Comparison the effects of 2 month of regular
Aerobic exercise and vitamin B6 intake on the
Symptoms of premenstrual syndrome in Non-Athlete student girls
The main objective of this project is to Comparison the effects exercise of aerobic and vitamin B6 intake on the symptoms of premenstrual-syndrome in Non-athlete girls. 60 girl university students in Khorasgan University with inclusion and exclusion criteria: aged between 18-25 years old; single; heahthy; with regular menstrual periods and Non-Athlete were chosen by the use of complementary questionnaires including dairy symptoms recording table, (DMS-IV) Premenstrual syndrome, General Health (GHQ28), Beck depression and anxiety questionnaire and were divided in three Aerobic exercise and vitamin B6 and control groups randomly. The activities lasted for 2 months, 3 sessions in a week, and each session 60 minutes. The experimental group vitamins B6 were used a pill every day for 2 months. After 1 months the PMS questionnaire was distributed among the 3 groups again (mid-test) and after 2 months the posttest was conducted. The results show that physical and psychological symptoms reduced after 1 and 2 months exercise and vitamin B6 intake. Also the results indicate that the mean score in decreasing physical, psychological symptoms and total score in Aerobic was more than vitamins B6 and control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082614428N2
Registration date:2013-10-27, 1392/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-27, 1392/08/05
Registrant information
Name
Zeinab Samadi
Name of organization / entity
Islamic Azad University, Khorasgan (Isfahan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1231 3100
Email address
samadi1404@yahoo.com
Recruitment status
Recruitment complete
Funding source
IslamiIslamic Azad University, Khorasgan
Expected recruitment start date
2011-06-26, 1390/04/05
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of 2 month of regular
Aerobic exercise and vitamin B6 intake on the
Symptoms of premenstrual syndrome in Non-Athlete student girls
Public title
Comparison the effects of 2 month of regular
Aerobic exercise and vitamin B6 intake on the
Symptoms of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18-25 years old; single; with regular menstrual periods; bleeding between menstrual cycle length of 22-35 days ,for 3-8 days.
Exclusion criteria : history of regular physical activity for 3 months before starting the study and during the study;history of diseases such as asthma, diabetes, renal, cardiac, psychiatric, thyroid, epilepsy;medication or being on a special diet.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
290064
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Physical symptoms premenstrual syndrome
Timepoint
After, 1 months the PMS and after 2 months the posttest
Method of measurement
Questionnaires including dairy symptoms recording table, (DMS-IV) PMS, General Health (GHQ28), Beck depression and anxiety questionnaire
2
Description
Psychological symptoms premenstrual syndrome
Timepoint
After, 1 months and after 2 months the posttest
Method of measurement
Questionnaires including dairy symptoms recording table, (DMS-IV) PMS, General Health (GHQ28), Beck depression and anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group vitamins B6 were used a pill every day for 2 months.
Category
Treatment - Drugs
2
Description
The activities lasted for 8 weeks, 3 sessions in a week, and each session 60 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
, IslamiIslamic Azad University, Khorasgan (Isfahan) Branch
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Muosavi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery, Isfahan 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
Islamic Azad University, Khorasgan (Isfahan) Branch
Full name of responsible person
zeinab samadi
Position
MSC
Other areas of specialty/work
Street address
Islamic Azad University, Khorasgan (Isfahan) Branch
City
Isfahan
Postal code
Phone
+98 913 268 7830
Fax
Email
samadi1404@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan (Isfahan) Branch
Full name of responsible person
zeinab samadi
Position
MSC
Other areas of specialty/work
Street address
Arghavanieh street, Jey street.
City
Isfahan
Postal code
Phone
+98 913 268 7830
Fax
Email
samadi1404@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan (Isfahan) Branch
Full name of responsible person
zeinab samadi
Position
MSc
Other areas of specialty/work
Street address
Arghavanieh street, Jey street.
City
Isfahan
Postal code
Phone
00
Fax
Email
Samadi1404@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)