Protocol summary

Summary
The overall Aim of this study was to determine the Effect of combind continues and interval aerobic training on body composition, aerobic power, muscular strength, and some serum biochemistry and hemodynamic indices of men with metabolic syndrome. Thirty patients with the metabolic syndrome defined according to the Adult Treatment Panel III criteria were selected. The patients were randomized and stratified (by age, Weight and VO2max) into exercise (n15) or control group (n15). Participants in exercise group received combined continues and interval aerobic training with a slope of 2% on a treadmill 3 times a week for 16 weeks. They warmed up for 5 minutes at 50% of maximal heart rate (Hrmax) before performing 20 minutes Continuous at 70% of Hrmax and 4 minutes intervals at 90% of Hrmax with 3 minutes active recovery at 70% of Hrmax between intervals and 5 minutes cool-down period, giving a total exercise time of 55 minutes. The control group followed their routine life activities. Body composition, physical parameters and metabolic indices were measured in both groups at first, middle and the end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812233565N1
Registration date: 2009-07-23, 1388/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-07-23, 1388/05/01
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Trbriz University and Tabriz University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined continues and interval aerobic training on body composition, aerobic power, muscular strength and some serum Biochemistry and hemodynamic indices in males with metabolic syndrome
Public title
Effect of physical activity in the treatment of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male sex, Having sufficient criteria for diagnosing metabolic syndrome (according to ATP III definition), willingness to participate in the study, waist in the thinnest area 107 ±5 cm, age 50 ± 5 Exclusion criteria: any chronic or severe acute illness, inability to do the physical activity, having orthopedic problems not able to do this physical activity, unwillingness to participate in the study
Age
From 44 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Tabriz University of Medical Sciences
Street address
Research vice chancellor of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2009-10-11, 1388/07/19
Ethics committee reference number
5480/4/5

Health conditions studied

1

Description of health condition studied
Metablic Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determine and compare of some indicators of body composition (thickness of subcutaneous fat, abdominal obesity) in all groups before and after intervention.
Timepoint
Before training - at the end of the eighth week - at the end of the sixteenth week.
Method of measurement
Subcutaneous fat thickness will be achieved using a thickness gauge device (Kalypr) and three point formula (behind the arm, abdomen and above the hip) Faculty of America Sports Medicine (ACSM).

Secondary outcomes

1

Description
levels of insulin resistance and beta cell function
Timepoint
Before training, weeks 8 and 16 after the intervention
Method of measurement
fasting blood glucose and insulin measure by using spectrophotometry and ELISA kit respectively and insulin resistance and beta cell function determined by HOMA-IR and HOMA-β-cell.

2

Description
The thigh muscles power
Timepoint
Before training, weeks 8 and 16 after the intervention
Method of measurement
individuals isometric thigh muscle strenth (the length) determined by dynamometr

3

Description
The aerobic power
Timepoint
Before training, weeks 8 and 16 after the intervention
Method of measurement
Aerobic power persons (maximum oxygen consumption) determined by the Bruce treadmill test.

4

Description
levels of lipid profiles (TG, HDL, LDL and TC)
Timepoint
Before training, weeks 8 and 16 after the intervention
Method of measurement
Each variables are measured by a specific biochemical methods. (TC,TG and HDL measured by kit and LDL calculated by this formol LDL= TC- (HDL – TG/5).

5

Description
Blood pressure
Timepoint
Before training, weeks 8 and 16
Method of measurement
Resting blood pressure will be measured by Mercury mannometer

Intervention groups

1

Description
Intervention group: combined continues and interval aerobic training (respectively 70 and 90% of maximum heart rate)with a slope of 2% on a treadmill 3 times a week for 16 weeks. Total exercise time was 55 minutes each session.
Category
Other

2

Description
Control group: routine physical activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hamid Esmaeli
Street address
Golgashat avenue, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Tabriz Univesity
Full name of responsible person
Alireza Ostadrahimi
Street address
Research vice-chancellor of Tabriz University of Medical Sciences
City
Tabriz
Grant name
124202- 10506
Grant code / Reference number
124202
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences and Tabriz Univesity
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
Tabriz University
Full name of responsible person
Hamid Esmaili
Position
Student, senior exercise physiology
Other areas of specialty/work
Street address
Gargar, Hadishahr
City
Hadishahr
Postal code
5431743319
Phone
+98 49 2304 7717
Fax
Email
h_esmaili64@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Akbar Aliasgharzadeha
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
asgharzadeha@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Dr Akbar Aliasgharzadeha
Position
Associate Professor
Other areas of specialty/work
Street address
Golgasht avenue, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
asgharzadeha@gmail.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
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