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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05231564
Other study ID # no grant
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date February 1, 2020

Study information

Verified date February 2022
Source University of Sistan and Baluchestan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Modern living and physical inactivity results in many ailments, including obesity, non-alcoholic fatty liver disease (NAFLD), and inflammatory issues. Though there are a lot of studies on physical training, there is little detail on hybrid training or electrical and voluntary contractions of the musculature. This study investigated the efficiency of hybrid training in biochemistry, ultrasound, and proinflammatory outcomes in middle-aged sedentary and obese women with NAFLD.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 1, 2020
Est. primary completion date December 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Sedentary women with one to two exercise sessions or less per month - BMI equal to or above 30 kg/m-2 - WHR equal or above 0.85 m - Confirmed NAFLD, with grade 2 and 3 - Systolic blood pressure not less than 130 mm Hg and diastolic blood pressure not less than 85 mm Hg - Increased AST and ALT - Mean age 45-65 years Exclusion Criteria: - Use of 140 grams or more of ethanol per week - History of depression in the last 6 months - History of chronic or acute viral hepatitis - Drug-related liver disease and chronic liver disease - History of diabetes - Uncontrolled hypertension - Myocardial infarction - Chronic kidney disease - Hyperthyroidism or heart failure - Those who have weight loss programs or medical contraindications for physical training - Serious arterial hemorrhagic disorders - Serious neurological diseases - Advanced atherosclerosis - Elevated fever

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hybrid training
The experimental group trained two to three sessions of 45 to 50 minutes a week with a recovery of 24 to 48 hours between each session to burn 500 kcal. The first three weeks held hybrid training with a metabolic program and the other three weeks held a strength training program.

Locations

Country Name City State
Iran, Islamic Republic of Mohammadreza Rezaeipour (MD, PhD) Zahedan Sistan And Baluchestan

Sponsors (2)

Lead Sponsor Collaborator
University of Sistan and Baluchestan Niloofar Zareie Mohammad Zadeh

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight in kg Pre-study
Primary Body Mass Index in kg/m-2 Pre-study
Primary Aspartate transaminases in u/l Pre-study
Primary Alanine transaminases in u/l Pre-study
Primary Fasting blood sugar in mg/dl Pre-study
Primary Proinflammatory cytokine (interleukin -6) in pg/ml Pre-study
Primary Ultrasonic assessment Grade of liver steatosis Pre-study
Primary WHR Waist-to-hip ratio in cm Pre-study
Primary SBP/DBP Systolic blood pressure/Diastolic blood pressure Pre-study
Primary HDL Cholesterol Plasma in mg/dl Pre-study
Secondary Body Weight in kg six-week
Secondary Body Mass Index in kg/m-2 six-week
Secondary Aspartate transaminases in u/l six-week
Secondary Alanine transaminases in u/l six-week
Secondary Fasting blood sugar in mg/dl six-week
Secondary Proinflammatory cytokine (interleukin -6) in pg/ml six-week
Secondary Ultrasonic assessment Grade of liver steatosis six-week
Secondary WHR Waist-to-hip ratio in cm six-week
Secondary SBP/DBP Systolic blood pressure/Diastolic blood pressure six-week
Secondary HDL Cholesterol Plasma in mg/dl six-week
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