- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555457
Intermittent Walking Training and Cardiometabolic Health in Premenopausal and Postmenopausal Women
Effects of a 10-Week Moderate-Intensity Intermittent Walking Training Program on Aerobic Capacity, Cardiometabolic Risk Factors, and Inflammatory Markers in Premenopausal and Postmenopausal Women
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
In premenopausal and postmenopausal women, differences in cardiometabolic profile, body composition, and aerobic capacity are commonly observed, with postmenopausal women generally presenting higher cardiometabolic risk. Regular physical activity is known to improve these parameters; however, the specific effects of moderate-intensity intermittent walking training (MIWT) on the comparison between premenopausal and postmenopausal women remain insufficiently explored.
The purpose of this study is to compare the effects of a 10-week moderate-intensity intermittent walking training (MIWT) program on aerobic capacity, body composition, cardiometabolic risk factors, and inflammatory markers in premenopausal and postmenopausal women.
Thirty-two women were allocated into a premenopausal group (n = 16) and a postmenopausal group (n = 16). Both groups performed a MIWT program three times per week for 10 weeks. Each training session consisted 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 (6MWT), heart rate, blood pressure, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), and C-reactive protein (CRP) were assessed before and after the intervention in both groups to evaluate changes induced by the training program.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wissal Abassi Dr
- Phone Number: +21693304684
- Email: wissalabassi93@gmail.com
Study Locations
-
-
Boulifa
-
El Kef, Boulifa, Tunisia, 7100
- High Institute of Sport and Physical Education of Kef, University of Jendouba
-
Contact:
- Wissal Abassi Dr
- Phone Number: +21693304684
- Email: wissalabassi93@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cardiovascular diseases (hypertension, heart failure).
- Presence of metabolic or inflammatory disorders (e.g., uncontrolled diabetes, autoimmune diseases, active infections).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Premenopausal Women Receiving MIWT Program
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.
|
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.
|
|
Experimental: Postmenopausal Women Receiving MIWT Program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
BMI calculated as weight (kg) divided by height squared (m²).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Body Fat Percentage
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Total body fat measured by digital scale (Tanita BC-533).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Waist Circumference
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
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
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
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)
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Serum CRP concentration (mg/L).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Total Cholesterol
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Serum total cholesterol concentration (mg/dL).
|
Baseline and after the 10 weeks of the training intervention.
|
|
High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Serum HDL cholesterol concentration (mg/dL).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Low-Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Serum LDL cholesterol concentration (mg/dL).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Triglycerides
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Serum triglyceride concentration (mg/dL).
|
Baseline and after the 10 weeks of the training intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test (6MWT) Distance
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Distance walked in 6 minutes on a 30-meter straight corridor.
|
Baseline and after the 10 weeks of the training intervention.
|
|
Blood Pressure (Systolic and Diastolic)
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Measured using an automated arm cuff (Omron BP652).
|
Baseline and after the 10 weeks of the training intervention.
|
|
Resting Heart Rate
Time Frame: Baseline and after the 10 weeks of the training intervention.
|
Measured using automated device (Omron BP652).
|
Baseline and after the 10 weeks of the training intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IW-CardioWomen-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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