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CompletedNCT05231564Updated Feb 28, 2022

Hybrid Training and Middle Age

An interventional study of hybrid training in Women's Health, Hybrid Training and Middle Aged, sponsored by University of Sistan and Baluchestan. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by University of Sistan and Baluchestan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Nov 2019, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Women's Health
  • Hybrid Training
  • Middle Aged
  • Non-alcoholic Fatty Liver Disease
  • Metabolic Syndrome
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 15 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University of Sistan and Baluchestan is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Hybrid training

    15 women for hybrid training.

    Other: hybrid training

  • No intervention
    Healthy lifestyle counseling

    15 women for healthy lifestyle counseling

Interventions

  • Otherhybrid 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.

06

What researchers measure

Primary outcomes

  1. Body Weight

    in kg

    Time frame: Pre-study

  2. Body Mass Index

    in kg/m-2

    Time frame: Pre-study

  3. Aspartate transaminases

    in u/l

    Time frame: Pre-study

  4. Alanine transaminases

    in u/l

    Time frame: Pre-study

  5. Fasting blood sugar

    in mg/dl

    Time frame: Pre-study

  6. Proinflammatory cytokine (interleukin -6)

    in pg/ml

    Time frame: Pre-study

  7. Ultrasonic assessment

    Grade of liver steatosis

    Time frame: Pre-study

  8. WHR

    Waist-to-hip ratio in cm

    Time frame: Pre-study

  9. SBP/DBP

    Systolic blood pressure/Diastolic blood pressure

    Time frame: Pre-study

  10. HDL Cholesterol Plasma

    in mg/dl

    Time frame: Pre-study

Secondary outcomes

  1. Body Weight

    in kg

    Time frame: six-week

  2. Body Mass Index

    in kg/m-2

    Time frame: six-week

  3. Aspartate transaminases

    in u/l

    Time frame: six-week

  4. Alanine transaminases

    in u/l

    Time frame: six-week

  5. Fasting blood sugar

    in mg/dl

    Time frame: six-week

  6. Proinflammatory cytokine (interleukin -6)

    in pg/ml

    Time frame: six-week

  7. Ultrasonic assessment

    Grade of liver steatosis

    Time frame: six-week

  8. WHR

    Waist-to-hip ratio in cm

    Time frame: six-week

  9. SBP/DBP

    Systolic blood pressure/Diastolic blood pressure

    Time frame: six-week

  10. HDL Cholesterol Plasma

    in mg/dl

    Time frame: six-week

07

Study locations

1 site
  • Mohammadreza Rezaeipour (MD, PhD)
    Zahedan, Sistan And Baluchestan 9816745639, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05231564
Lead sponsor
University of Sistan and Baluchestan
Collaborators
Niloofar Zareie Mohammad Zadeh
Responsible party
Mohammadreza Rezaeipour (Asst.Prof.Dr. of sports science, University of Sistan and Baluchestan) — Principal investigator
First posted
Feb 9, 2022
Start date
Nov 1, 2019
Primary completion
Dec 2, 2019
Completion
Feb 1, 2020
Last update
Feb 28, 2022

Study contacts

Mohammadreza Rezaeipour, MD, PhD
principal investigator · University of Sistan and Baluchestan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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