The purpose of this study program of aerobic exercise on serum transaminase and trance is the quality of life in patients with alcoholic steatohepatitis.Thirty NASH patients with the range of age 18 to 65 years old that randomly they were divided in two groups of diet (n=15) and aerobic training with diet (n=15).Patients with inclusion criteria: 1 - 18 to 65 years 2 - Approval Kbdchrb ultrasound 3 - Increase 5 / 1 Equity serum enzyme alanine aminotransferase (ALT) and Exclusion criteria: 1 - Hepatitis B2-hepatitis C 3 - autoimmune hepatitis 4 - CD 5 - Wilson 6 - 1α-deficient anti ¬ trypsin 7 - Hemochromatosis 8 - 9 thyroid disease - ischemic heart disease 10 - 11 of kidney failure - drugs Hpatvtvksyk 12 - more than 20 grams of alcohol per day were enrolled. Anthropometric indices, serum liver enzymes and biochemical factors were evaluated before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104286319N1
Registration date:2011-08-27, 1390/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-27, 1390/06/05
Registrant information
Name
Hamidreza Sima
Name of organization / entity
Mashhad University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 3363
Email address
simahr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-09-22, 1389/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment effect of aerobic training program on serum transaminases' levels and quality of life in patients with Non-Alcoholic Steatohepatitis
Public title
The Effect of Exercise and nutrition on fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 65 years ; Approval Kbdchrb ultrasound; Increase 1.5 Equity serum enzyme alanine aminotransferase. Exclusion criteria: Hepatitis B2; Hepatitis C; Autoimmune hepatitis; CD; Wilson; 1α-deficient anti-trypsin; Hemochromatosis; thyroid disease; Ischemic heart disease; kidney failure; Drugs Hpatvtvksyk; More than 20 grams of alcohol per day.
Age
From 18 years old to 65 years old
Gender
Both
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
Mashhad University of Medical Sciences
Street address
School of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
9177948564
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
89878
Health conditions studied
1
Description of health condition studied
Non Alcoholic Steatohepatitis
ICD-10 code
K70-K77
ICD-10 code description
Diseases of liver
Primary outcomes
1
Description
ALT
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Unit U / L, a photometer methods
2
Description
AST
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Unit U / L, a photometer methods
3
Description
FBS
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
4
Description
Insulin
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mIU/mL
5
Description
Chol
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
6
Description
LDL
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
7
Description
HDL
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
8
Description
VLDL
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
9
Description
TG
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
mg/dL
10
Description
Weight
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
gram
11
Description
BMI
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Kg/M2
12
Description
WC
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Cm
13
Description
WHpR
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
%
14
Description
WHtR
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
%
15
Description
HC
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Cm
16
Description
PBF
Timepoint
Before the intervention, two months after the start and end of three months
Method of measurement
Body Composition
17
Description
Quality of life
Timepoint
before and after intervention
Method of measurement
SF-36 Standard questionnaire
Secondary outcomes
1
Description
Height
Timepoint
Before the intervention, two months later and after three months
Method of measurement
Cm
Intervention groups
1
Description
Diet with aerobic training program
Category
Treatment - Devices
2
Description
Diet alone
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Liver researches, Department of Internal Hospital, Imam Reza Mashhad
Full name of responsible person
Dr Hamid Reza Sima
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Sima
Street address
School of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Nematy
Position
Assistant Professor in Clinical Nutrition
Other areas of specialty/work
Street address
School of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1882 8569
Fax
Email
NematyM@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hamid reza Sima
Position
Advanced Hepatology Fellowship
Other areas of specialty/work
Street address
School of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mshhad
Postal code
Phone
+98 51 1859 8818
Fax
Email
Simahr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hossein Nikroo
Position
MA
Other areas of specialty/work
Street address
No 19, 11th Emamat, Emamat Boulevard
City
Mashhad
Postal code
Phone
+98 51 1605 4628
Fax
Email
Gym.hnikroo@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)