Women's HealthNCT05231564
Hybrid Training and Middle Age
A study testing hybrid training in people with Women's Health and Hybrid Training, run by University of Sistan and Baluchestan at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health, Hybrid Training, Middle Aged
- What is being tested?
- hybrid training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mohammadreza Rezaeipour (MD, PhD)
Zahedan, Sistan and Baluchestan, 9816745639
About this study
Official title: 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.
- Conditions
- Women's Health, Hybrid Training, Middle Aged, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
- Being tested
- hybrid training
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid training | Experimental | 15 women for hybrid training. Receives: Other: hybrid training |
| Healthy lifestyle counseling | No intervention | 15 women for healthy lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
in kg
Measured: Pre-study
Body Mass Index
in kg/m-2
Measured: Pre-study
Aspartate transaminases
in u/l
Measured: Pre-study
Alanine transaminases
in u/l
Measured: Pre-study
Fasting blood sugar
in mg/dl
Measured: Pre-study
Proinflammatory cytokine (interleukin -6)
in pg/ml
Measured: Pre-study
Ultrasonic assessment
Grade of liver steatosis
Measured: Pre-study
WHR
Waist-to-hip ratio in cm
Measured: Pre-study
SBP/DBP
Systolic blood pressure/Diastolic blood pressure
Measured: Pre-study
HDL Cholesterol Plasma
in mg/dl
Measured: Pre-study
Secondary outcomes (10)
Body Weight
in kg
Measured: six-week
Body Mass Index
in kg/m-2
Measured: six-week
Aspartate transaminases
in u/l
Measured: six-week
Alanine transaminases
in u/l
Measured: six-week
Fasting blood sugar
in mg/dl
Measured: six-week
Proinflammatory cytokine (interleukin -6)
in pg/ml
Measured: six-week
Ultrasonic assessment
Grade of liver steatosis
Measured: six-week
WHR
Waist-to-hip ratio in cm
Measured: six-week
SBP/DBP
Systolic blood pressure/Diastolic blood pressure
Measured: six-week
HDL Cholesterol Plasma
in mg/dl
Measured: six-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Nov 2019
- Primary completion2 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sistan and Baluchestan
- Sponsor type
- University, hospital or other
- Collaborators
- Niloofar Zareie Mohammad Zadeh
- Responsible party
- Principal investigator, Mohammadreza Rezaeipour, University of Sistan and Baluchestan
- Investigators
- Mohammadreza Rezaeipour, MD, PhD, Principal investigator, University of Sistan and Baluchestan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231564
- Sponsor's protocol ID
- no grant
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41137140
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hybrid Training on Lipid Profile and Non-alcoholic Fatty Liver Disease in Middle-aged Obese Women
- ClinicalTrials.gov ID
- NCT05231564
- Acronym / sponsor ID
- no grant
- Conditions
- Women's Health, Hybrid Training, Middle Aged, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sistan and BaluchestanUniversity, hospital or other
- Collaborators
- Niloofar Zareie Mohammad Zadeh
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Hybrid training | Experimental | Other: hybrid training15 women for hybrid training. |
| Healthy lifestyle counseling | No intervention | –15 women for healthy lifestyle counseling |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hybrid trainingThe 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. | Other | Hybrid training |
Primary outcome
Body Weight
Time frame: Pre-study
in kg
Body Mass Index
Time frame: Pre-study
in kg/m-2
Aspartate transaminases
Time frame: Pre-study
in u/l
Alanine transaminases
Time frame: Pre-study
in u/l
Fasting blood sugar
Time frame: Pre-study
in mg/dl
Proinflammatory cytokine (interleukin -6)
Time frame: Pre-study
in pg/ml
Ultrasonic assessment
Time frame: Pre-study
Grade of liver steatosis
WHR
Time frame: Pre-study
Waist-to-hip ratio in cm
SBP/DBP
Time frame: Pre-study
Systolic blood pressure/Diastolic blood pressure
HDL Cholesterol Plasma
Time frame: Pre-study
in mg/dl
10 secondary outcomes
Body Weight
Time frame: six-week
Body Mass Index
Time frame: six-week
Aspartate transaminases
Time frame: six-week
Alanine transaminases
Time frame: six-week
Fasting blood sugar
Time frame: six-week
Proinflammatory cytokine (interleukin -6)
Time frame: six-week
Ultrasonic assessment
Time frame: six-week
WHR
Time frame: six-week
SBP/DBP
Time frame: six-week
HDL Cholesterol Plasma
Time frame: six-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 41137140Mohammadzadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammadreza Rezaeipour, MD, PhD principal investigator
University of Sistan and Baluchestan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hybrid training in people with Women's Health and Hybrid Training, run by University of Sistan and Baluchestan at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Pre-study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.