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The Effect of aerobic exercise on hepatic enzymes and tissue after the intratracheal instillation of iron oxide nanoparticles in wistar rats

Protocol summary

Summary
Background & objective : In this study we investigated the effect of concurrent aerobic exercise and inhalation iron oxide nanoparticles on hepatic enzymes; ALT, AST, ALP and histological hepatic appearance. Design: This study was an experimental study with post-test and control group. Inclusion criteria: public health; physical ability; normal limbs. Exclusion criteria: physical disability. 48 wistar rats with a mean weight of 250gr were randomly divided into six equal groups including of the experimental 1(aerobic, exercise), experimental 2(nanoparticle, anesthesia), experimental 3(aerobic exercise, nanoparticles & anesthesia), placebo 4(distillated water, anesthesia), placebo 5(aerobic exercise, anesthetists), and control group. In group 2 and 3,40mg/ kgbw iron oxide nanoparticles injected every other day for a period of 14 days with lung induction method. Groups 4, 1, and 3 had to run on treadmill everyday for 30 minutes with the intensity of 35% to 40%VO2max. Intervention: intratracheal instillation of iron oxide nanoparticles, aerobic exercise. Main Outcome Measures (variables): 24 hours after last exercise session blood samples were analyzed to measure the amount of hepatic enzymes(ALT, AST, ALP). For histopathology examination the tissue sections were studied by light microscope.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021816624N1
Registration date: 2014-03-25, 1393/01/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Azadeh Vasili
Name of organization / entity
Khorasgan(Isfahan)Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4135
Email address
a.vasili@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of aerobic exercise on hepatic enzymes and tissue after the intratracheal instillation of iron oxide nanoparticles in wistar rats
Public title
The Effect of aerobic exercise on hepatotoxicity induced by intratracheal instillation of iron oxide nanoparticles in wistar rats
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: public health; physical ability; normal limbs Exclusion criteria: physical disability.
Age
From 1 year old to 1 year old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 48
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
Regional Committee for Medical Research Ethics of the vice chancellor for research, Isfahan Universi
Street address
Bldg no4, Isfahan medical university, Hezarjrib st, Isfahan
City
Isfahan
Postal code
81745-319
Approval date
2014-02-10, 1392/11/21
Ethics committee reference number
492044

Health conditions studied

1

Description of health condition studied
hepatotoxicity
ICD-10 code
K71.1
ICD-10 code description
Hepatic failure (acute)(chronic) due to drugs

Primary outcomes

1

Description
ALT
Timepoint
14 days after the intervention
Method of measurement
Enzyme units per liter

2

Description
AST
Timepoint
14 days after the intervention
Method of measurement
Enzyme units per liter

3

Description
ALP
Timepoint
14 days after the intervention
Method of measurement
Enzyme units per liter

Secondary outcomes

1

Description
Hepatic tissue sections
Timepoint
14 days after the intervention
Method of measurement
Observed slides hepatic tissues sections

Intervention groups

1

Description
Experimental 3(aerobic exercise, nanoparticles & anesthesia): in this group, at first rats ran on a treadmill then anesthetized and iron oxide nanoparticles were injected into their trachea. Aerobic exercise: male wistar rats were trained to do low-intensity aerobic exercise. With an intensity of approximately 35% to 40% VO2max, they ran on a motor-driven treadmill designed for rats for 30 minutes in each day within 2 weeks. The sequence of this exercise were as follows: exercise in 5 minutes at a speed of 6 m/min, exercise in 5 minutes at a speed of 9 m/min and exercise in 20 minutes at a speed of 12 m/min with a running intensity of 35% to 40% VO2max. Intratracheal instillation of Iron oxide nanoparticles: as concerns intratracheal instillation for every injection, a 0.1ml dose of 100mg/ml distilled water and IONPs suspension solution has been injected into the rat's thetrachea. The required amount of dose was 40mg/kgbw. Administration repeated 7 times every other day in 14 day. At any time of the injection, the rats were anesthetized by inhalation of ether and weighed.
Category
Treatment - Drugs

2

Description
Experimental group (1)(aerobic exercise): in this group male wistar rats were trained to do low-intensity aerobic exercise. With an intensity of approximately 35% to 40% VO2max, they ran on a motor-driven treadmill designed for rats for 30 minutes in each day within 2 weeks. The sequence of this exercise were as follows: exercise in 5 minutes at a speed of 6 m/min, exercise in 5 minutes at a speed of 9 m/min and exercise in 20 minutes at a speed of 12 m/min with a running intensity of 35% to 40% VO2max.
Category
Other

3

Description
Experimental 2(nanoparticle, anesthesia): as concerns intratracheal instillation for every injection, a 0.1ml dose of 100mg/ml distilled water and IONPs suspension solution has been injected into the rat's thetrachea. The required amount of dose was 40mg/kgbw. Administration repeated 7 times every other day in 14 day. At any time of the injection, the rats were anesthetized by inhalation of ether and weighed.
Category
Diagnosis

4

Description
Control group: this group did not receive any intervention and were weighed every day.
Category
Diagnosis

5

Description
Placebo 4(distillated water, anesthesia): as concerns intratracheal instillation for every injection, a 0.1ml distilled water has been injected into the rat's thetrachea. Administration repeated 7 times every other day in 14 day. At any time of the injection, the rats were anesthetized by inhalation of ether and weighed.
Category
Treatment - Drugs

6

Description
Placebo 5(aerobic exercise, anesthetists): at first rats ran on a treadmill then anesthetized and weighed. Rats were trained to do low-intensity aerobic exercise. With an intensity of approximately 35% to 40% VO2max, they ran on a motor-driven treadmill designed for rats for 30 minutes in each day within 2 weeks. The sequence of this exercise were as follows: exercise in 5 minutes at a speed of 6 m/min, exercise in 5 minutes at a speed of 9 m/min and exercise in 20 minutes at a speed of 12 m/min with a running intensity of 35% to 40% VO2max.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Veterinary clinic of doctor Shahriyar Adibi
Full name of responsible person
Doctor Shahriyar Adibi(DVM)
Street address
NO.12, three-way airport, East J St, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research, Islamic Azad University Isfahan(Khorasgan)Branch
Full name of responsible person
Doctor Payam Najafi
Street address
University Blvd, Arghavanyeh, Khorasgan, Isfahan
City
Isfahan
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, Islamic Azad University Isfahan(Khorasgan)Branch
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
Islamic Azad University Isfahan(Khorasgan) Branch
Full name of responsible person
Doctor Gholamreza Sharifi
Position
Faculty member of Khorasgan Islamic Azad University
Other areas of specialty/work
Street address
University Blvd, Arghavanyeh, Khorasgan, Isfahan
City
Isfahan
Postal code
8195158
Phone
+98 31 1535 4135
Fax
+98 31 1535 4135
Email
gre_sharifi@yahoo.com
Web page address
http://www.khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Isfahan(Khorasgan) Branch
Full name of responsible person
Azadeh Vasili
Position
graduate student of exercise physiology
Other areas of specialty/work
Street address
University Blvd, Arghavanyeh, Khorasgan, Isfahan
City
Isfahan
Postal code
8195158
Phone
+98 31 1445 4105
Fax
+98 31 1265 8569
Email
a.vasili@khuisf.ac.ir; vasili.mgh@gmail.com; vasili.azadeh@yahoo.com
Web page address
http://www.khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Shahrekord
Full name of responsible person
Doctor Mohammad Faramarzi
Position
Faculty member of Shahrekord University
Other areas of specialty/work
Street address
2km Samanroad, Shahrekord
City
Shahrekord
Postal code
8818634141
Phone
+98 38 1442 0361
Fax
+98 38 1442 0361
Email
md.faramarzi@gmail.com
Web page address
www.sku.ac.ir

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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