Hybrid Training and Middle Age

February 9, 2022 updated by: Mohammadreza Rezaeipour, University of Sistan and Baluchestan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hybrid training
15 women for hybrid training.
Other: hybrid 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.
No Intervention: Healthy lifestyle counseling
15 women for healthy lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Pre-study
in kg
Pre-study
Body Mass Index
Time Frame: Pre-study
in kg/m-2
Pre-study
Aspartate transaminases
Time Frame: Pre-study
in u/l
Pre-study
Alanine transaminases
Time Frame: Pre-study
in u/l
Pre-study
Fasting blood sugar
Time Frame: Pre-study
in mg/dl
Pre-study
Proinflammatory cytokine (interleukin -6)
Time Frame: Pre-study
in pg/ml
Pre-study
Ultrasonic assessment
Time Frame: Pre-study
Grade of liver steatosis
Pre-study
WHR
Time Frame: Pre-study
Waist-to-hip ratio in cm
Pre-study
SBP/DBP
Time Frame: Pre-study
Systolic blood pressure/Diastolic blood pressure
Pre-study
HDL Cholesterol Plasma
Time Frame: Pre-study
in mg/dl
Pre-study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: six-week
in kg
six-week
Body Mass Index
Time Frame: six-week
in kg/m-2
six-week
Aspartate transaminases
Time Frame: six-week
in u/l
six-week
Alanine transaminases
Time Frame: six-week
in u/l
six-week
Fasting blood sugar
Time Frame: six-week
in mg/dl
six-week
Proinflammatory cytokine (interleukin -6)
Time Frame: six-week
in pg/ml
six-week
Ultrasonic assessment
Time Frame: six-week
Grade of liver steatosis
six-week
WHR
Time Frame: six-week
Waist-to-hip ratio in cm
six-week
SBP/DBP
Time Frame: six-week
Systolic blood pressure/Diastolic blood pressure
six-week
HDL Cholesterol Plasma
Time Frame: six-week
in mg/dl
six-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sistan and Baluchestan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Niloofar Zareie Mohammad Zadeh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • No grant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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