Protocol summary

Summary
This study is a randomized control trial. The objective of this study is to investigate the effect of moderate to severe aerobic exercise on appetite. In this study 46 women with body mass index ≥25 who don't have disease that affecting physical activity, heart rate or nutrition status will be recruited and randomly assigned into intervention groups. The patients in one intervention group will received morning aerobic exercise with moderate to severe intensity during 8 weeks. The patients in other group will received the same exercise protocol in the evening. Appetite, Rating perceived exertion, Weight, Body mass index, Percentage body fat will be measured before and after the intervention and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112287903N2
Registration date: 2012-01-05, 1390/10/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-05, 1390/10/15
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of morning and evening aerobic exercise on appetite in overweight women
Public title
Aerobic exercise and appetite
Purpose
Prevention
Inclusion/Exclusion criteria
Female,without pregnancy or regular physical activity or cigarette smoking, Without any diseases that affect the heart rate, diet or physical activity, without significant weight reduction over the past 6 months
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
The Center of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2011-12-25, 1390/10/04
Ethics committee reference number
90-03-53-15004-42656

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
(E65-E68)
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
Appetite
Timepoint
0 and 8 week
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Weight reduction
Timepoint
0 and 8 week
Method of measurement
Standard analogue scale

Intervention groups

1

Description
Aerobic exercise, 3-5 days per week with moderate to high intensity
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam khomeini Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alamdar Elahe
Street address
4th Floor, The Center of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor of Sports Medicine
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.irza_al10@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor of Sports Medicine
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21886302278
Fax
Email
z_alizadeh@tums.ac.irza_al10@yahoo.com
Web page address

Person responsible for updating data

Contact

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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