Cardiometabolic Health in Premenopausal and Postmenopausal WomenNCT07555457
Intermittent Walking Training and Cardiometabolic Health in Premenopausal and Postmenopausal Women
A study testing Moderate-Intensity Intermittent Walking Training (MIWT) in people with Cardiometabolic Health in Premenopausal and Postmenopausal Women, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 65 years, women only
- Conditions the study is for
- Cardiometabolic Health in Premenopausal and Postmenopausal Women
- What is being tested?
- Moderate-Intensity Intermittent Walking Training (MIWT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTunisia
- Study dates
- 21 May 2026to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cardiovascular diseases (hypertension, heart failure).
- Presence of metabolic or inflammatory disorders (e.g., uncontrolled diabetes, autoimmune diseases, active infections).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
High Institute of Sport and Physical Education of Kef, University of Jendouba
El Kef, Boulifa, 7100
Wissal Abassi Dr, +21693304684, wissalabassi93@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Moderate-Intensity Intermittent Walking Training (MIWT)
- Keywords
- Intermittent walking, Premenopausal women, Postmenopausal women, Cardiometabolic health, C-reactive protein, Lipid profile, Aerobic capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Intermittent Walking Training (MIWT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moderate-Intensity Intermittent Walking Training (MIWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²).
Measured: Baseline and after the 10 weeks of the training intervention.
Body Fat Percentage
Total body fat measured by digital scale (Tanita BC-533).
Measured: 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.
Measured: Baseline and after the 10 weeks of the training intervention.
Hip Circumference
Measured at the widest point of the hips using a tape measure.
Measured: Baseline and after the 10 weeks of the training intervention.
C-Reactive Protein (CRP)
Serum CRP concentration (mg/L).
Measured: Baseline and after the 10 weeks of the training intervention.
Total Cholesterol
Serum total cholesterol concentration (mg/dL).
Measured: Baseline and after the 10 weeks of the training intervention.
High-Density Lipoprotein (HDL) Cholesterol
Serum HDL cholesterol concentration (mg/dL).
Measured: Baseline and after the 10 weeks of the training intervention.
Low-Density Lipoprotein (LDL) Cholesterol
Serum LDL cholesterol concentration (mg/dL).
Measured: Baseline and after the 10 weeks of the training intervention.
Triglycerides
Serum triglyceride concentration (mg/dL).
Measured: Baseline and after the 10 weeks of the training intervention.
Secondary outcomes (3)
6-Minute Walk Test (6MWT) Distance
Distance walked in 6 minutes on a 30-meter straight corridor.
Measured: Baseline and after the 10 weeks of the training intervention.
Blood Pressure (Systolic and Diastolic)
Measured using an automated arm cuff (Omron BP652).
Measured: Baseline and after the 10 weeks of the training intervention.
Resting Heart Rate
Measured using automated device (Omron BP652).
Measured: Baseline and after the 10 weeks of the training intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start21 May 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Health in Premenopausal and Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
- Investigators
- Wissal Abassi, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555457
- Sponsor's protocol ID
- IW-CardioWomen-2026
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07555457
- Acronym / sponsor ID
- IW-CardioWomen-2026
- Keywords
- Intermittent walking, Premenopausal women, Postmenopausal women, Cardiometabolic health, C-reactive protein, Lipid profile, Aerobic capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 21 May 2026 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women Receiving MIWT Program | Experimental | Behavioral: Moderate-Intensity Intermittent Walking Training (MIWT)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. |
| Postmenopausal Women Receiving MIWT Program | Experimental | Behavioral: Moderate-Intensity Intermittent Walking Training (MIWT)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. |
Who may qualify
- Ages
- 32 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Cardiovascular diseases (hypertension, heart failure).
- Presence of metabolic or inflammatory disorders (e.g., uncontrolled diabetes, autoimmune diseases, active infections).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Intermittent Walking Training (MIWT)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. | Behavioural | Postmenopausal Women Receiving MIWT Program, Premenopausal Women Receiving MIWT Program |
Primary outcome
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).
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).
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.
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.
C-Reactive Protein (CRP)
Time frame: Baseline and after the 10 weeks of the training intervention.
Serum CRP concentration (mg/L).
Total Cholesterol
Time frame: Baseline and after the 10 weeks of the training intervention.
Serum total cholesterol concentration (mg/dL).
High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline and after the 10 weeks of the training intervention.
Serum HDL cholesterol concentration (mg/dL).
Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline and after the 10 weeks of the training intervention.
Serum LDL cholesterol concentration (mg/dL).
Triglycerides
Time frame: Baseline and after the 10 weeks of the training intervention.
Serum triglyceride concentration (mg/dL).
3 secondary outcomes
6-Minute Walk Test (6MWT) Distance
Time frame: 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.
Resting Heart Rate
Time frame: Baseline and after the 10 weeks of the training intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wissal Abassi principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Intermittent Walking Training (MIWT) in people with Cardiometabolic Health in Premenopausal and Postmenopausal Women, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wissal Abassi Dr (+21693304684, wissalabassi93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Baseline and after the 10 weeks of the training intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.