The major aim of the current study is to investigate the effects of 10 weeks aerobics exercise accompanied by vitamin E supplementation on blood pressure, heart rate, and VO2max consumption in addicted women. This study will be a phase 2 trial not blind with a pre-test and post-test. The population of this experimental study is addicted women in Zahedan Addiction Camp. Based on simplified random sampling 38 addicted women will be chosen and classified into four groups, exercise + placebo (n = 10), exercise + vitamin E (n=10), vitamin E (n=10) and placebo (n = 8) and will receive supplementation and placebo during10 weeks. The experimental group will be studied for 10 weeks (three sessions per a week) 40 up to 50 minutes with 40 to 75 percent maximum heart rate. Before the training the main variables such as blood pressure, heart rate, maximal oxygen uptake, as well as secondary variables, body mass index and weight will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082223715N1
Registration date:2016-04-16, 1395/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-16, 1395/01/28
Registrant information
Name
Somaye Aram
Name of organization / entity
University of Sistan and Baluchestan، Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 3350 4189
Email address
m_ghofrani2000@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-11-28, 1393/09/07
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of ten weeks aerobic exercise accompanied by vitamin E supplement consumption on addicted women's blood pressure, Heart rate, and vo2max
Public title
Effects of aerobic exercise and supplementation with vitamin E in the treatment of addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all people in the Addiction Camp.
those with diseases such as blood fat , blood sugar ؛blood pressure. Cancer Or any other disease :Exclusion criteria
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of zahedan University of Medical Sciences
Street address
Doctor Hesabi Field ،End of the University street
City
zahedan
Postal code
Approval date
2014-11-27, 1393/09/06
Ethics committee reference number
129-933/3/6017
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the intervention and at the end of 10 weeks
Method of measurement
Common Indicator
2
Description
Heart Reat
Timepoint
Before the intervention and at the end of 10 weeks
Method of measurement
Polar Rate monitor
3
Description
Maximum Oxygen uptake
Timepoint
Before the intervention and at the end of 10 weeks
Method of measurement
1600 miles march teast
Secondary outcomes
1
Description
Weight
Timepoint
Before the intervention and at the end of 10 weeks
Method of measurement
Digital Balance
2
Description
Body mass index
Timepoint
Before the intervention and at the end of 10 weeks
Method of measurement
Weight divided by the square of height
Intervention groups
1
Description
Intervention group1: Exercise + Placebo؛ Aerobic exercise ، For 10 weeks، 3 Seance a week؛
Starch Placebo 0.4 gram، on befor lunch daily، for 10 weeks
Category
Other
2
Description
Intervention group2: Exercise + Vitamin E، Earobic exercise، For 10 weeks،3 Seance a week؛ Vitamin E : 400 doses، on before lunch daily، for 10 weeks، Pharmaceutical company Dana
Category
Other
3
Description
Control group: Starch 0.4 gram، on before lunch daily، for 10 weeks
Category
Placebo
4
Description
Intervention group3: Vitamin E 400 doses، on before lunch daily ، for 10 weeks، Dana pharmaceutical company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
women quit addiction Camp
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research University of Sistan and Baluchestan
Full name of responsible person
Kordi Tamandani Dor Mohammad Docter
Street address
Central Organization University of Sistan and Baluchestan
City
zahedan
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 University of Sistan and Baluchestan
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
University of Sistan and Baluchestan Zahedan
Full name of responsible person
Aram Somaye
Position
Student
Other areas of specialty/work
Street address
Saadi 67Alley ، Saadi Westerly street، Zahedan
City
Zahedan
Postal code
Phone
+98 54 3350 4189
Fax
Email
Somaye.Aram67@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sistan and BaluchestanZahedan
Full name of responsible person
Ghofrani Mohsen
Position
Sport Management. Ph.d
Other areas of specialty/work
Street address
Faculty of Physical Education،University of Sistan and Baluchestan ،Zahedan
City
Zahedan
Postal code
Phone
+98 54 3343 1065
Fax
Email
m_ghofrani2000@ped.usb.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)