Moderate Intensity Intermittent Walking in Postmenopausal Women

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.

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Markers; Liver Enzymes
• Intervention / Treatment: Behavioral: Walking training intervention

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Kef
    • Boulifa, Kef, Tunisia, 7100
      • High Institute of Sports and Physical Education of Kef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; 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.	Behavioral: Walking training intervention; 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.
No Intervention: Control group; No training intervention was intended for this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	At baseline and at week 11(after the ten weeks of the training intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	At baseline and after ten weeks of the training intervention.

Collaborators and Investigators

• Sponsor: Wissal Abassi

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: C-reactive protein; Alkaline phosphatase; Erythrocyte sedimentation rate; Walking training; Alanine transaminase; Postmenopausal obesity
• Other Study ID Numbers: Walking and liver function

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For confidentiality reasons, all data from this study are available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No