Hybrid Training and Middle Age

Study of Hybrid Training on Lipid Profile and Non-alcoholic Fatty Liver Disease in Middle-aged Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Women's Health; Middle Aged; Hybrid Training
• Intervention / Treatment: Other: hybrid training

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Sistan And Baluchestan
    • Zahedan, Sistan And Baluchestan, Iran, Islamic Republic of, 9816745639
      • Mohammadreza Rezaeipour (MD, PhD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid training; 15 women for hybrid training.	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.
No Intervention: Healthy lifestyle counseling; 15 women for healthy lifestyle counseling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sistan and Baluchestan
• Collaborators: Niloofar Zareie Mohammad Zadeh
• Investigators: Principal Investigator: Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Liver Diseases; Fatty Liver; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: No grant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No