Back to resultsHybrid Training and Middle Age
Primary Purpose
Women's Health, Hybrid Training, Middle Aged
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hybrid training
Sponsored by
About this trial
This is an interventional supportive care trial for Women's Health
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
Sites / Locations
- Mohammadreza Rezaeipour (MD, PhD)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hybrid training
Healthy lifestyle counseling
Arm Description
15 women for hybrid training.
15 women for healthy lifestyle counseling
Outcomes
Primary Outcome Measures
Body Weight
in kg
Body Mass Index
in kg/m-2
Aspartate transaminases
in u/l
Alanine transaminases
in u/l
Fasting blood sugar
in mg/dl
Proinflammatory cytokine (interleukin -6)
in pg/ml
Ultrasonic assessment
Grade of liver steatosis
WHR
Waist-to-hip ratio in cm
SBP/DBP
Systolic blood pressure/Diastolic blood pressure
HDL Cholesterol Plasma
in mg/dl
Secondary Outcome Measures
Body Weight
in kg
Body Mass Index
in kg/m-2
Aspartate transaminases
in u/l
Alanine transaminases
in u/l
Fasting blood sugar
in mg/dl
Proinflammatory cytokine (interleukin -6)
in pg/ml
Ultrasonic assessment
Grade of liver steatosis
WHR
Waist-to-hip ratio in cm
SBP/DBP
Systolic blood pressure/Diastolic blood pressure
HDL Cholesterol Plasma
in mg/dl
Full Information
NCT ID
NCT05231564
First Posted
January 19, 2022
Last Updated
February 9, 2022
Sponsor
University of Sistan and Baluchestan
Collaborators
Niloofar Zareie Mohammad Zadeh
1. Study Identification
Unique Protocol Identification Number
NCT05231564
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sistan and Baluchestan
Collaborators
Niloofar Zareie Mohammad Zadeh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health, Hybrid Training, Middle Aged, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid training
Arm Type
Experimental
Arm Description
15 women for hybrid training.
Arm Title
Healthy lifestyle counseling
Arm Type
No Intervention
Arm Description
15 women for healthy lifestyle counseling
Intervention Type
Other
Intervention Name(s)
hybrid training
Intervention Description
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 Outcome Measure Information:
Title
Body Weight
Description
in kg
Time Frame
Pre-study
Title
Body Mass Index
Description
in kg/m-2
Time Frame
Pre-study
Title
Aspartate transaminases
Description
in u/l
Time Frame
Pre-study
Title
Alanine transaminases
Description
in u/l
Time Frame
Pre-study
Title
Fasting blood sugar
Description
in mg/dl
Time Frame
Pre-study
Title
Proinflammatory cytokine (interleukin -6)
Description
in pg/ml
Time Frame
Pre-study
Title
Ultrasonic assessment
Description
Grade of liver steatosis
Time Frame
Pre-study
Title
WHR
Description
Waist-to-hip ratio in cm
Time Frame
Pre-study
Title
SBP/DBP
Description
Systolic blood pressure/Diastolic blood pressure
Time Frame
Pre-study
Title
HDL Cholesterol Plasma
Description
in mg/dl
Time Frame
Pre-study
Secondary Outcome Measure Information:
Title
Body Weight
Description
in kg
Time Frame
six-week
Title
Body Mass Index
Description
in kg/m-2
Time Frame
six-week
Title
Aspartate transaminases
Description
in u/l
Time Frame
six-week
Title
Alanine transaminases
Description
in u/l
Time Frame
six-week
Title
Fasting blood sugar
Description
in mg/dl
Time Frame
six-week
Title
Proinflammatory cytokine (interleukin -6)
Description
in pg/ml
Time Frame
six-week
Title
Ultrasonic assessment
Description
Grade of liver steatosis
Time Frame
six-week
Title
WHR
Description
Waist-to-hip ratio in cm
Time Frame
six-week
Title
SBP/DBP
Description
Systolic blood pressure/Diastolic blood pressure
Time Frame
six-week
Title
HDL Cholesterol Plasma
Description
in mg/dl
Time Frame
six-week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The statistical population consisted of sedentary, obese middle-aged women who were not on medication.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammadreza Rezaeipour, MD, PhD
Organizational Affiliation
University of Sistan and Baluchestan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammadreza Rezaeipour (MD, PhD)
City
Zahedan
State/Province
Sistan And Baluchestan
ZIP/Postal Code
9816745639
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Hybrid Training and Middle Age
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