Protocol summary

Summary
Objectives: The main objective of this study is to investigate & survey the impact of aerobic exercises and weight-loss diet on Serum Follistatin level of the women. Design: A randomized clinical trial. Setting and Conduct: 39 women an average age of 39.5 were selected and divided into four experimenal groups : Aerobic (9), stair weight loss (10), Aerobics with stair weight loss diet (10) and Weight loss diet with low calorie(10). During eight weeks the aerobic group exercised three sessions a week (45 minutes work out with 60-80 % of maximum intensity), The stair weight loss group lowered the calorie intake by 20-40% gradually. The third group did aerobic exercise simultanously keeping stair weight loss diet tree times aweek. The fourth group performed their plan by lowering the calorie intake by 40% in a steady way. The anthropometric indexes, Body compositions and Follistatin serum contents were measured befor and after the exercise plan besides the experimental data were stetistically analyzed utilizing of Anova test. Participants including major eligibility Criteria: Inclusion criteria: 25<BMI<30; 30<age<45; No body consume drugs..; No body sick; No body pregnant; No body have hormone disorder; No body athlet Exclution criteria; 25>BMI>30;30>Age>45; consumhng drugs..; Illness; Pregnancy; hormon disorder; Bing Athlet. Main Outcome Measures: Serum Follistatin, Body weight.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031121434N1
Registration date: 2015-06-04, 1394/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Mahboubeh Tajik
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 7983
Email address
mtjk54@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ferdowsi University of Mashhad, Dr Ahmad Reza Bahrami
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an 8-week aerobic training and weight-loss diet on the level of serum follistatin for inactive middle-aged women
Public title
The effect of anaerobic training and weight-loss diet on the level of serum follistatin
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 25<BMI<30; 30<age<45; No body consume drugs..; No body sick; No body pregnant; No body have hormone disorder; No body athlet Exclution criteria; 25>BMI>30; 30>Age>45; consumhng drugs..; Illness; Pregnancy; Hormon disorder; Bing Athlet.
Age
From 35 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 39
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

1

Registry name
-
Secondary trial Id
-
Registration date
empty

2

Registry name
-
Secondary trial Id
-
Registration date
empty

3

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
9177948974
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
-

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Serum Follistatin
Timepoint
Befor & After
Method of measurement
Biocemistry Test

2

Description
Body Weight
Timepoint
Befor & After
Method of measurement
Body Analiser

Secondary outcomes

1

Description
Body Fat percent
Timepoint
Before&After test
Method of measurement
Body Analiser

2

Description
Body Mass Index
Timepoint
Before & After test
Method of measurement
Body Analiser

Intervention groups

1

Description
Aerobic training Group; the aerobics group exercised 3 sessions a week (45 minutes each session with 60-80 % of maximum intensity).
Category
Other

2

Description
Weight-loss diet Group; low calorie group lowered their calorie intake by 40% from first of experiment.
Category
Other

3

Description
Stair weight-loss diet Group; stair diet group lowered their calorie intake by 20-40% gradually.
Category
Other

4

Description
Aerobic training + Stair weight-loss diet Group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Mahboubeh Tajik
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Ferdowsi University of Mashhad
Full name of responsible person
Ahmad Reza Bahrami
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
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,Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Tajik Mahboubeh
Position
M.Sc. in Sport & Exercise Physiology
Other areas of specialty/work
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
9177948974
Phone
+98 51 3881 7983
Fax
+98 51 3881 7983
Email
mtjk54@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Rashidlamir Amir
Position
Assistance Professor in Sport & Exercise Physiology
Other areas of specialty/work
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
9177948974
Phone
+98 51 3881 7983
Fax
+98 51 3881 7983
Email
mtjk54@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Tajik Mahboubeh
Position
M.Sc. in Sport and Exercise Physiology
Other areas of specialty/work
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
9177948974
Phone
+98 51 3881 7983
Fax
+98 51 3881 7983
Email
mtjk54@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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