Clinical trial NCT05231564: Hybrid Training and Middle Age
Official title: Study of Hybrid Training on Lipid Profile and Non-alcoholic Fatty Liver Disease in Middle-aged Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Hybrid Training
Middle Aged
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Lead sponsor: University of Sistan and Baluchestan
Sponsor class: OTHER
Collaborators: name: Niloofar Zareie Mohammad Zadeh
First posted: 2022-02-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: Pre-study
measure: Body Mass Index
timeFrame: Pre-study
measure: Aspartate transaminases
timeFrame: Pre-study
measure: Alanine transaminases
timeFrame: Pre-study
measure: Fasting blood sugar
timeFrame: Pre-study
measure: Proinflammatory cytokine (interleukin -6)
timeFrame: Pre-study
measure: Ultrasonic assessment
timeFrame: Pre-study
measure: WHR
timeFrame: Pre-study
measure: SBP/DBP
timeFrame: Pre-study
measure: HDL Cholesterol Plasma
timeFrame: Pre-study
Secondary outcomes:
measure: Body Weight
timeFrame: six-week
measure: Body Mass Index
timeFrame: six-week
measure: Aspartate transaminases
timeFrame: six-week
measure: Alanine transaminases
timeFrame: six-week
measure: Fasting blood sugar
timeFrame: six-week
measure: Proinflammatory cytokine (interleukin -6)
timeFrame: six-week
measure: Ultrasonic assessment
timeFrame: six-week
measure: WHR
timeFrame: six-week
measure: SBP/DBP
timeFrame: six-week
measure: HDL Cholesterol Plasma
timeFrame: six-week
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Mohammadreza Rezaeipour (MD, PhD)
state: Sistan And Baluchestan
Study officials:
affiliation: University of Sistan and Baluchestan
name: Mohammadreza Rezaeipour, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: