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Completed

NCT Number: NCT06809270

Moderate Intensity Intermittent Walking in Postmenopausal Women

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.

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Key information

Conditions

Liver Enzymes Inflammatory Markers

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

Walking training intervention

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

Secondary outcomes

  1. Body composition

    Time frame: At baseline and after ten weeks of the training intervention.

    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).

  2. Aerobic capacity

    Time frame: At baseline and after ten weeks of the training intervention.

    The 6-minute walk test was performed before and after the training intervention as an indicator of exercise capacity.

Sponsors and collaborators

Lead sponsor

Wissal Abassi

Other

Registry information

Official study title

Liver Function and Inflammation in Obese Postmenopausal Women: Responses to Moderate Intensity Intermittent Walking

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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