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Comparing the effects of Aerobic exercise with Whole-Body vibration versus Aerobic exercise alone in Non-Alcoholic Fatty Liver diseases

Protocol summary

Summary
The main aim of this study is to compare the effects of Aerobic exercise along with Whole-Body vibration, versus Aerobic exercise alone, on Bio-chemicals of Non-Alcoholic Fatty Liver patients. This is a randomized, interventional clinical trial. Inclusion criteria: Non Alcoholic Fatty liver disease grade I and II, which is diagnosed in ultrasound imaging; BMI= 27-35 Exclusion criteria: Alcohol intake> 5 units/weak; Hepatotoxic drugs; Other exercise contraindication such as Cardiopulmonary disease or Muscloskeletal problems. Sampling Method: Simple sampling. Sample Quantity: 32 Patients. Gastrointestinalogist will refer 32 patients one by one and then, Lipid profiles and Liver enzymes, as primary outcomes for all patients will be tested and divided into two groups randomly. Intervention group will be placed under 5minutes of Whole-Body vibration and then Aerobic exercises, for 24 sessions, 40minutes each, whereas, the Control group will be placed under Aerobic exercises only, for 24 sessions, 40minutes each. Finally Lipid profiles and Liver enzymes for both groups will be tested and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604162664N3
Registration date: 2016-05-28, 1395/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Yaghoub Salekzamani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3967
Email address
salekzamaniy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparing the effects of Aerobic exercise with Whole-Body vibration versus Aerobic exercise alone in Non-Alcoholic Fatty Liver diseases
Public title
Effects of the Whole-Body vibration, in Non-Alcoholic Fatty Liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non Alcoholic Fatty liver disease grade I and II, which is diagnosed in ultrasound imaging; BMI= 27-35 Exclusion criteria: Alcohol intake> 5 units/weak; Hepatotoxic drugs such as Amiodaron, Tomoxifen, MTX, Fibrat or others; Exercise contraindications such as Cardiopulmonary disease or Muscloskeletal problems.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Ethics committee ofTabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
tbzmed.rec.1394.37

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K75.8, K76
ICD-10 code description
Nonalcoholic steatohepatitis (NASH), Nonalcoholic fatty liver disease (NAFLD)

Primary outcomes

1

Description
Lipid Profile (TG, Chol, LDL. HDL)
Timepoint
Before and after intervention
Method of measurement
Biochemical laboratory

2

Description
Liver Enzyme (ALP, ALT, AST)
Timepoint
Before and after intervention
Method of measurement
Biochemical laboratory

Secondary outcomes

1

Description
Weight, height, waist to hip ratio, fat mass, lean body mass, BMI
Timepoint
Before and after intervention
Method of measurement
Body Composition Analizer

Intervention groups

1

Description
Control group: 40 min (3 days/weak) aerobic exercise for 8 weeks
Category
Treatment - Other

2

Description
Intervention group: 8 weeks (3 days/weak) aerobic exercise, duration 40 min with 5 min whole body vibration before exercise
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadi medical clinic
Full name of responsible person
Dr. Manouchehr khoshbaten, gastrointestinologist, professor of university
Street address
Sixth floor, Azadi medical clinic, Aazadi street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rooya Dolatkhah
Street address
Physical medicine and Rehabilitation center, Emamraza hospital, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Physical medicine and Rehabilitation group of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Morteza Haghverdi
Position
Resident of Physical medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Center, Emamreza hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
mrz.haghverdi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Physical Medicine and Rehabilitation center of Tabriz University of Medical Sciences
Full name of responsible person
Yaghob Salekzamaniy
Position
Assistant professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Center, Emamreza hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
salekzamaniy@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Physical medicine and Rehabilitation center of Tabriz University of Medical Sciences
Full name of responsible person
Morteza Haghverdi
Position
Rsident of Physical medicine and Rehabilitation
Other areas of specialty/work
Street address
Emamreza Hospital, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
mrz.haghverdi@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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