NCT05231564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

January 19, 2022

Last Update Submit

February 9, 2022

Conditions

Women's HealthHybrid TrainingMiddle AgedNon-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (10)

  • Body Weight

    six-week

  • Body Mass Index

    six-week

  • Aspartate transaminases

    six-week

  • Alanine transaminases

    six-week

  • Fasting blood sugar

    six-week

  • +5 more secondary outcomes

Study Arms (2)

Hybrid training

EXPERIMENTAL

15 women for hybrid training.

Other: hybrid training

Healthy lifestyle counseling

NO INTERVENTION

15 women for healthy lifestyle counseling

Interventions

hybrid trainingOTHER

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.

Hybrid training

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe statistical population consisted of sedentary, obese middle-aged women who were not on medication.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammadreza Rezaeipour (MD, PhD)

Zahedan, Sistan and Baluchestan, 9816745639, Iran

Location

Related Publications (1)

  • Mohammadzadeh NZ, Rezaeipour M. "Hybrid exercise training improves liver steatosis and inflammation in a randomized trial of sedentary, obese women with non-alcoholic fatty liver disease". BMC Sports Sci Med Rehabil. 2025 Oct 24;17(1):308. doi: 10.1186/s13102-025-01349-2.

    PMID: 41137140DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mohammadreza Rezaeipour, MD, PhD

    University of Sistan and Baluchestan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr. of sports science

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 9, 2022

Study Start

November 1, 2019

Primary Completion

December 2, 2019

Study Completion

February 1, 2020

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

IR(1)