Clinical trial NCT06809270: Moderate Intensity Intermittent Walking in Postmenopausal Women
Official title: Liver Function and Inflammation in Obese Postmenopausal Women: Responses to Moderate Intensity Intermittent Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Enzymes
Inflammatory Markers
Keywords: Alanine transaminase
Alkaline phosphatase
Postmenopausal obesity
C-reactive protein
Walking training
Erythrocyte sedimentation rate
Lead sponsor: High Institute of Sports and Physical Education of Kef
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 36
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alanine transaminase
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
measure: Aspartate transaminase
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
measure: Alkaline phosphatase
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
measure: Gamma glutamyl transferase
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention)
measure: Serum bilirubin
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
measure: C reactive protein
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
measure: Erythrocyte sedimentation rate
timeFrame: At baseline and at week 11(after the ten weeks of the training intervention).
Secondary outcomes:
measure: Body composition
timeFrame: At baseline and after ten weeks of the training intervention.
measure: Aerobic capacity
timeFrame: At baseline and after ten weeks of the training intervention.
Other outcomes:
Locations:
city: Boulifa
country: Tunisia
facility: High Institute of Sports and Physical Education of Kef
state: Kef
Study officials:
References: