Protocol summary

Summary
The aim of this study is to investigate posibble heart hypertrophy, as a result of training (Traditional and HIT) based on the path defined for clinical observed (echocardiography), measuring proteins associated with hypertrophy (IGF-I and PI3K) as well as measuring gene expression in leukocytes p110δ is the genomic level. Design Randomized controlled quasi-experimental study that was conducted on 36 students. inclusion criteria is male gender, and having age between 20-30years and being in the normal range of body mass index and exclusion criteria of the research history of professional sports as well as the current regular exercise, no smoking, no disease cardiovascular, pulmonary, metabolic and musculoskeletal as well as anyinjury that impair the implementation of physical activity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201603039460N2
Registration date: 2016-03-31, 1395/01/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-31, 1395/01/12
Registrant information
Name
Arash Saadatnia
Name of organization / entity
Shahid Beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2940
Email address
a_saadatnia@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-21, 1393/06/30
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing effect of traditional continuous training and high intensity interval training on cardiac hypertrophic indexes, PI3k gene expression and cardiac function
Public title
comparing effect of traditional continuous training and high intensity interval training on cardiac morphology and function
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria include age between-30, male gender and being in BMI normal range. Exclusion criteria include professional athletics history as well as the current regular exercise, smoking, cardiovascular and metabolic disease or any complication that disrupt the implementation of exercise
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
we use random numbers table to assigning subjects into three groups randomly

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad, Mashhad, Iran
Street address
Azadi ave
City
mashhad
Postal code
978646342
Approval date
2013-09-21, 1392/06/30
Ethics committee reference number
19868

Health conditions studied

1

Description of health condition studied
healthy subjects which participate in physical activity
ICD-10 code
Z00.8
ICD-10 code description
Health examination in population surveys

Primary outcomes

1

Description
VO2max
Timepoint
pre intervention- post intervention
Method of measurement
Bruce treadmill test

2

Description
Stroke Volume
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

3

Description
ejection Fraction
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

4

Description
Left ventricle volume
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

5

Description
End of systolic volume
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

6

Description
End of diastolic volume
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

7

Description
inter ventricular septum
Timepoint
pre intervention- post intervention
Method of measurement
echocardiography

8

Description
plasma IGF-I levels
Timepoint
pre intervention- post intervention
Method of measurement
ELISA Kit

9

Description
PI3K activity
Timepoint
pre intervention- post intervention
Method of measurement
ELISA Kit

10

Description
p110δ Gene expression in luekocytes
Timepoint
pre intervention- post intervention
Method of measurement
PCR

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: HIT group Exercises included warm up, HIT training, cool down. Subjects warmed up by stretching and easy walking for 5 minutes. The HIT interventions consisted of four 30 s maximal effort (“all-out”) shuttle run bouts (from cone-1 to cone-2 ,20 meter sweep) separated by 1.5 min passive rest each . HIT protocol began with 4 cycles/session and every two weeks added one cycle. Finally it was 8 cycles/session in tenth week that lasted 16 minutes. Cooling Down also included 5 min of walking and stretching. During the HIT interventions all subjects were vocally encouraged to maintain Maximal effort.
Category
Other

2

Description
Intervention 2: consists of 20 minutes of running continuously at heart rate of approximately 140 continuously that started three sessions per week for fourth weeks and gradually increased in tenth week to 40 minutes.
Category
Other

3

Description
control: Control group asked to be sedentary in this period.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Arash Saadatnia
Street address
Azadi ave
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Dr arsh saadatnia
Street address
velenjak
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti university
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
Shahid Beheshti University
Full name of responsible person
arash saadatnia
Position
PHD
Other areas of specialty/work
Street address
Shahid Beheshti University, Velenjak, Tehran, I.R. IRAN
City
tehran
Postal code
1983969411
Phone
+98 212293615
Fax
Email
arash.denatation@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
khosrow ebrahim
Position
Professor
Other areas of specialty/work
Street address
Shahid Beheshti University, Velenjak, Tehran, I.R. IRAN
City
tehran
Postal code
1983969411
Phone
+98 212294323
Fax
Email
k-ebrahim@sbu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
arash saadatnia
Position
PHD Candidate
Other areas of specialty/work
Street address
Shahid Beheshti University, Velenjak, Tehran, I.R. IRAN
City
tehran
Postal code
1983969411
Phone
+98 21 2990 2761
Fax
Email
arash.denatation@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
empty
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