Moderate Intensity Intermittent Walking in Postmenopausal Women

NCT06809270 | Completed DMC

• 1 other identifier: Walking and liver function
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Enzymes; Inflammatory Markers

Keywords

Alanine transaminase; Alkaline phosphatase; Postmenopausal obesity; C-reactive protein; Walking training; Erythrocyte sedimentation rate

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Body composition

  At baseline and after ten weeks of the training intervention.

• Aerobic capacity

  At baseline and after ten weeks of the training intervention.

Study Arms (2)

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.

Behavioral: Walking training intervention

Control group

NO INTERVENTION

No training intervention was intended for this group.

Interventions

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.

Training group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wissal Abassi: lead

Study Sites (1)

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 5, 2025
• Study Start: September 23, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)