Liver EnzymesNCT06809270
Moderate Intensity Intermittent Walking in Postmenopausal Women
A study testing Walking training intervention in people with Liver Enzymes and Inflammatory Markers, run by Wissal Abassi at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to investigate the impact of a walking training intervention program on liver enzymes and selected inflammatory markers in postmenopausal women with obesity. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Liver Enzymes, Inflammatory Markers
- What is being tested?
- Walking training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Sep 2024to 22 Dec 2024
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women included are:
- Postmenopausal (≥1 year of amenorrhea).
- Obese (body mass index (BMI) ≥30 kg/m2).
- Sedentary (<120 min/week of low to moderate intensity physical activity at during the past 6 months).
- Aged 50 to 60 years.
Who cannot join
- Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
- Being under menopausal hormone therapy.
- Presenting any orthopedic limitations interfering the ability to perform the study intervention.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sports and Physical Education of Kef
Boulifa, Kef Governorate, 7100
About this study
Official title: Liver Function and Inflammation in Obese Postmenopausal Women: Responses to Moderate Intensity Intermittent Walking
The goal of this clinical trial is to investigate the impact of a walking training intervention program on liver enzymes and selected inflammatory markers in postmenopausal women with obesity. The main question it aims to answer is:
Does walking training reduce the risk of liver disease by modulating hepatic-enzymes and selected inflammatory markers? Researchers will compare walking training intervention (designed to the experimental group) to non-training intervention (designed to the control group) to see if the training program works to improve liver health in obese postmenopausal women.
Read more
Participants in the experimental (training) group will: underwent a moderate intensity intermittent walking training (MIWT) at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session.
Participants in control group will : not perform any physical training and maintain their usual daily activities.
Read the detailed description
Postmenopausal obesity is an important public health problem accompanied by increased systemic inflammation that escalates the risk of liver disease. Exercise improved inflammatory and hepatic function. Moderate-intensity intermittent-walking-training (MIWT) is the most feasible for obese-postmenopausal-women. This study aimed to investigate whether MIWT could reduce the risk by modulating hepatic-enzymes and selected inflammatory markers. Thirty-six sedentary obese postmenopausal women (mean age 55.7±3.5) were randomly divided into two groups: training group (TG, n=18) and control group (CG, n=18). The TG underwent a MIWT at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session. Body composition, hepatic (alanine-transaminase (ALT), aspartate-transaminase (AST), alkaline-phosphatase, gamma-glutamyl-transferase (GGT) and serum-bilirubin] and inflammatory markers [C-reactive-protein (CRP), and erythrocyte-sedimentation-rate (ESR)) were evaluated at baseline and after 10-week of protocol.
- Conditions
- Liver Enzymes, Inflammatory Markers
- Being tested
- Walking training intervention
- Keywords
- Alanine transaminase, Alkaline phosphatase, Postmenopausal obesity, C-reactive protein, Walking training, Erythrocyte sedimentation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking training interventionBehavioural
Moderate intensity intermittent walking training for a period of 10 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is four times a week.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | The training group underwent a moderate intensity intermittent walking training at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session for a period of 10 weeks. Receives: Behavioral: Walking training intervention |
| Control group | No intervention | No training intervention was intended for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine transaminase
Serum concentrations of alanine-transaminase (ALT) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Aspartate transaminase
Serum concentrations of aspartate-transaminase (AST),are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Alkaline phosphatase
Serum concentrations of alkaline-phosphatase are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Gamma glutamyl transferase
Serum concentrations of gamma-glutamyl-transferase (GGT),are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: At baseline and at week 11(after the ten weeks of the training intervention)
Serum bilirubin
Serum concentrations of bilirubin are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
C reactive protein
Serum concentration of C-reactive-protein (CRP) are measured from a blood sample (5 ml).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Erythrocyte sedimentation rate
Erythrocyte-sedimentation-rate (ESR) are measured from a blood sample (5 ml).
Measured: At baseline and at week 11(after the ten weeks of the training intervention).
Secondary outcomes (2)
Body composition
Body composition were determined, with barefoot and lightly dressed subjects, using a stadiometer (Holtain Ltd., UK) and an electronic scale (Tanita BC-533, Tokyo, Japan).
Measured: At baseline and after ten weeks of the training intervention.
Aerobic capacity
The 6-minute walk test was performed before and after the training intervention as an indicator of exercise capacity.
Measured: At baseline and after ten weeks of the training intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Sep 2024
- Primary completion22 Dec 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver EnzymesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissal Abassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809270
- Sponsor's protocol ID
- Walking and liver function
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Function and Inflammation in Obese Postmenopausal Women: Responses to Moderate Intensity Intermittent Walking
- ClinicalTrials.gov ID
- NCT06809270
- Acronym / sponsor ID
- Walking and liver function
- Conditions
- Liver Enzymes, Inflammatory Markers
- Keywords
- Alanine transaminase, Alkaline phosphatase, Postmenopausal obesity, C-reactive protein, Walking training, Erythrocyte sedimentation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wissal AbassiUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (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.
The goal of this clinical trial is to investigate the impact of a walking training intervention program on liver enzymes and selected inflammatory markers in postmenopausal women with obesity. The main question it aims to answer is:
Does walking training reduce the risk of liver disease by modulating hepatic-enzymes and selected inflammatory markers? Researchers will compare walking training intervention (designed to the experimental group) to non-training intervention (designed to the control group) to see if the training program works to improve liver health in obese postmenopausal women.
Participants in the experimental (training) group will: underwent a moderate intensity intermittent walking training (MIWT) at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session.
Participants in control group will : not perform any physical training and maintain their usual daily activities.
Detailed description
Postmenopausal obesity is an important public health problem accompanied by increased systemic inflammation that escalates the risk of liver disease. Exercise improved inflammatory and hepatic function. Moderate-intensity intermittent-walking-training (MIWT) is the most feasible for obese-postmenopausal-women. This study aimed to investigate whether MIWT could reduce the risk by modulating hepatic-enzymes and selected inflammatory markers. Thirty-six sedentary obese postmenopausal women (mean age 55.7±3.5) were randomly divided into two groups: training group (TG, n=18) and control group (CG, n=18). The TG underwent a MIWT at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session. Body composition, hepatic (alanine-transaminase (ALT), aspartate-transaminase (AST), alkaline-phosphatase, gamma-glutamyl-transferase (GGT) and serum-bilirubin] and inflammatory markers [C-reactive-protein (CRP), and erythrocyte-sedimentation-rate (ESR)) were evaluated at baseline and after 10-week of protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: Walking training interventionThe training group underwent a moderate intensity intermittent walking training at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session for a period of 10 weeks. |
| Control group | No intervention | –No training intervention was intended for this group. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postmenopausal (≥1 year of amenorrhea).
- Obese (body mass index (BMI) ≥30 kg/m2).
- Sedentary (<120 min/week of low to moderate intensity physical activity at during the past 6 months).
- Aged 50 to 60 years.
Key exclusion criteria (3 listed)
- Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
- Being under menopausal hormone therapy.
- Presenting any orthopedic limitations interfering the ability to perform the study intervention.
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 |
|---|---|---|
| Walking training interventionModerate intensity intermittent walking training for a period of 10 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is four times a week. | Behavioural | Training group |
Primary outcome
Alanine transaminase
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Serum concentrations of alanine-transaminase (ALT) are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Aspartate transaminase
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Serum concentrations of aspartate-transaminase (AST),are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Alkaline phosphatase
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Serum concentrations of alkaline-phosphatase are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Gamma glutamyl transferase
Time frame: At baseline and at week 11(after the ten weeks of the training intervention)
Serum concentrations of gamma-glutamyl-transferase (GGT),are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
Serum bilirubin
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Serum concentrations of bilirubin are measured from a blood sample (5 ml) using a Chemistry System Analyzer (Beckman Coulter AU480, France).
C reactive protein
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Serum concentration of C-reactive-protein (CRP) are measured from a blood sample (5 ml).
Erythrocyte sedimentation rate
Time frame: At baseline and at week 11(after the ten weeks of the training intervention).
Erythrocyte-sedimentation-rate (ESR) are measured from a blood sample (5 ml).
2 secondary outcomes
Body composition
Time frame: At baseline and after ten weeks of the training intervention.
Aerobic capacity
Time frame: At baseline and after ten weeks of the training intervention.
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 13 Jun 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking training intervention in people with Liver Enzymes and Inflammatory Markers, run by Wissal Abassi at 1 site in Tunisia.
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 5 inclusion and 3 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 13 Jun 2025. 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 Tunisia. 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?
Alanine transaminase (time frame: At baseline and at week 11(after the ten weeks of the training intervention).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.