NCT07555457

Brief Summary

The goal of this clinical trial is to compare premenopausal and postmenopausal women regarding the effects of a 10-week moderate-intensity intermittent walking training (MIWT) program on aerobic capacity and selected cardiometabolic and inflammatory markers. The main question it aims to answer is: Does a MIWT program induce differential improvements in aerobic capacity, body composition, lipid profile, and inflammatory markers between premenopausal and postmenopausal women? Participants in the premenopausal group will perform a 10-week MIWT program, three sessions per week. Participants in the postmenopausal group will perform the same 10-week MIWT program, three sessions per week. Each training session consists of 5 repetitions of 6-minute walking (6MWT) at 60-80% of the baseline 6MWT distance, interspersed by 6 minutes of active recovery between repetitions. Body composition, aerobic capacity (6-minute walk test), heart rate, blood pressure, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), and C-reactive protein (CRP) will be assessed before and after the intervention in both groups.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 21, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Intermittent walkingPremenopausal womenPostmenopausal womenCardiometabolic healthC-reactive proteinLipid profileAerobic capacity

Outcome Measures

Primary Outcomes (9)

  • Body Mass Index (BMI)

    BMI calculated as weight (kg) divided by height squared (m²).

    Baseline and after the 10 weeks of the training intervention.

  • Body Fat Percentage

    Total body fat measured by digital scale (Tanita BC-533).

    Baseline and after the 10 weeks of the training intervention.

  • Waist Circumference

    Measured at the narrowest point between the rib cage and iliac crest using a tape measure.

    Baseline and after the 10 weeks of the training intervention.

  • Hip Circumference

    Measured at the widest point of the hips using a tape measure.

    Baseline and after the 10 weeks of the training intervention.

  • C-Reactive Protein (CRP)

    Serum CRP concentration (mg/L).

    Baseline and after the 10 weeks of the training intervention.

  • Total Cholesterol

    Serum total cholesterol concentration (mg/dL).

    Baseline and after the 10 weeks of the training intervention.

  • High-Density Lipoprotein (HDL) Cholesterol

    Serum HDL cholesterol concentration (mg/dL).

    Baseline and after the 10 weeks of the training intervention.

  • Low-Density Lipoprotein (LDL) Cholesterol

    Serum LDL cholesterol concentration (mg/dL).

    Baseline and after the 10 weeks of the training intervention.

  • Triglycerides

    Serum triglyceride concentration (mg/dL).

    Baseline and after the 10 weeks of the training intervention.

Secondary Outcomes (3)

  • 6-Minute Walk Test (6MWT) Distance

    Baseline and after the 10 weeks of the training intervention.

  • Blood Pressure (Systolic and Diastolic)

    Baseline and after the 10 weeks of the training intervention.

  • Resting Heart Rate

    Baseline and after the 10 weeks of the training intervention.

Study Arms (2)

Premenopausal Women Receiving MIWT Program

EXPERIMENTAL

Participants in the premenopausal group will perform a 10-week moderate-intensity intermittent walking training (MIWT) program, with three supervised sessions per week. Each session consists of 5 repetitions of 6-minute walking (6-minute walk test, 6MWT) performed at 60-80% of the baseline 6MWT distance, interspersed by 6 minutes of active recovery between repetitions. Body composition, aerobic capacity, heart rate, blood pressure, lipid profile, and C-reactive protein will be assessed before and after the intervention.

Behavioral: Moderate-Intensity Intermittent Walking Training (MIWT)

Postmenopausal Women Receiving MIWT Program

EXPERIMENTAL

Participants in the postmenopausal group will perform the same 10-week moderate-intensity intermittent walking training (MIWT) program, with three supervised sessions per week. Each session consists of 5 repetitions of 6-minute walking (6-minute walk test, 6MWT) performed at 60-80% of the baseline 6MWT distance, interspersed by 6 minutes of active recovery between repetitions. Body composition, aerobic capacity, heart rate, blood pressure, lipid profile, and C-reactive protein will be assessed before and after the intervention.

Behavioral: Moderate-Intensity Intermittent Walking Training (MIWT)

Interventions

Participants will perform a 10-week moderate-intensity intermittent walking training (MIWT) program, with three supervised sessions per week. Each session consists of 5 repetitions of 6-minute walking (6-minute walk test, 6MWT) performed at 60-80% of the baseline 6MWT distance, interspersed by 6 minutes of active recovery between repetitions. The same intervention is applied to both premenopausal and postmenopausal women.

Postmenopausal Women Receiving MIWT ProgramPremenopausal Women Receiving MIWT Program

Eligibility Criteria

Age32 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 32 to 43 years (premenopausal, with regular menstrual cycles for at least 12 months) or 49 to 65 years (postmenopausal, with absence of menstruation for at least 12 months).
  • Body mass index (BMI) \> 24.9 kg/m².
  • For the postmenopausal group: amenorrhea ≥ 12 months.
  • For the premenopausal group: regular menstrual cycles for at least 12 months.

You may not qualify if:

  • Cardiovascular diseases (hypertension, heart failure).
  • Presence of metabolic or inflammatory disorders (e.g., uncontrolled diabetes, autoimmune diseases, active infections).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Institute of Sport and Physical Education of Kef, University of Jendouba

El Kef, Boulifa, 7100, Tunisia

Location

Study Officials

  • Wissal Abassi

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start (Estimated)

May 21, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

For confidentiality reasons, all data from this study are available upon request.

Locations