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OpenTrials
Completed

NCT Number: NCT05231564

Hybrid Training and Middle Age

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.

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Key information

Conditions

Women's Health Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hybrid Training Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Middle Aged Non-Alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mohammadreza Rezaeipour (MD, PhD)

Zahedan, Sistan and Baluchestan, 9816745639, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hybrid training

Other

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.

Primary outcomes

  1. Body Weight

    Time frame: Pre-study

    in kg

  2. Body Mass Index

    Time frame: Pre-study

    in kg/m-2

  3. Aspartate transaminases

    Time frame: Pre-study

    in u/l

  4. Alanine transaminases

    Time frame: Pre-study

    in u/l

  5. Fasting blood sugar

    Time frame: Pre-study

    in mg/dl

  6. Proinflammatory cytokine (interleukin -6)

    Time frame: Pre-study

    in pg/ml

  7. Ultrasonic assessment

    Time frame: Pre-study

    Grade of liver steatosis

  8. WHR

    Time frame: Pre-study

    Waist-to-hip ratio in cm

  9. SBP/DBP

    Time frame: Pre-study

    Systolic blood pressure/Diastolic blood pressure

  10. HDL Cholesterol Plasma

    Time frame: Pre-study

    in mg/dl

Secondary outcomes

  1. Body Weight

    Time frame: six-week

    in kg

  2. Body Mass Index

    Time frame: six-week

    in kg/m-2

  3. Aspartate transaminases

    Time frame: six-week

    in u/l

  4. Alanine transaminases

    Time frame: six-week

    in u/l

  5. Fasting blood sugar

    Time frame: six-week

    in mg/dl

  6. Proinflammatory cytokine (interleukin -6)

    Time frame: six-week

    in pg/ml

  7. Ultrasonic assessment

    Time frame: six-week

    Grade of liver steatosis

  8. WHR

    Time frame: six-week

    Waist-to-hip ratio in cm

  9. SBP/DBP

    Time frame: six-week

    Systolic blood pressure/Diastolic blood pressure

  10. HDL Cholesterol Plasma

    Time frame: six-week

    in mg/dl

Sponsors and collaborators

Lead sponsor

University of Sistan and Baluchestan

Other

Collaborators

  • Niloofar Zareie Mohammad Zadeh

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 9, 2022
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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