- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264348
Cardiometabolic and Hormonal Adaptations to 4-Month Zumba Training in Overweight/Obese Women
Effects of a 4-month Intervention on Cardiometabolic, Hormonal, Inflammatory, Liver, Renal, Electrolyte, and Muscle Enzyme Parameters in Pre- and Post-Menopausal Overweight and Obese Women: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overweight and obesity are associated with metabolic dysregulation, hormonal imbalance, chronic inflammation, and reduced physical capacity. Zumba training is a dance-based aerobic exercise that can improve cardiovascular fitness, energy expenditure, and adherence to physical activity programs.
This study will assess the effects of a 4 month Zumba training program (4 sessions per week, 60 minutes per session) on: Body composition and anthropometric measures, Aerobic capacity, Hormonal profile, Lipid profile, Inflammatory biomarkers, Liver enzymes, Renal function markers, Electrolytes, Muscle enzymes, Pre- and post-training measurements will be taken under standardized conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wissal Abassi, Dr
- Phone Number: +21693304684
- Email: wissalabassi93@gmail.com
Study Contact Backup
- Name: wissal Abassi, Dr
- Email: wissalabassi93@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female, aged 18-65 years
- BMI ≥ 25 kg/m²
- Pre-menopausal or post-menopausal (classified clinically)
- Voluntary written informed consent
Exclusion Criteria:
- Hormonal therapy or weight-loss medications
- Endocrine diseases or chronic illness
- Recent intense physical training (<48 hours before baseline)
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: Experimental Group 1:Pre-menopausal
performed Zumba training, 4 × 60 min/week, 4 months
|
Participants assigned to the experimental groups will perform a supervised Zumba training program for 10 weeks, with 4 sessions per week, each session lasting 60 minutes.
Sessions will include a standardized warm-up (10 minutes), choreographed dance-based aerobic sequences performed at moderate intensity (40 minutes), and a cool-down with stretching (10 minutes).
|
|
No Intervention: Control Group 1
No training intervention was intended for the control group.
|
|
|
Experimental: Experimental Group 2:Post-menopausal
performed Zumba training, 4 × 60 min/week, 4 months
|
Participants assigned to the experimental groups will perform a supervised Zumba training program for 10 weeks, with 4 sessions per week, each session lasting 60 minutes.
Sessions will include a standardized warm-up (10 minutes), choreographed dance-based aerobic sequences performed at moderate intensity (40 minutes), and a cool-down with stretching (10 minutes).
|
|
No Intervention: Control group 2
No training intervention was intended for the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and after 4 months of Zumba intervention.
|
BMI calculated as weight (kg) divided by height squared (m²).
|
Baseline and after 4 months of Zumba intervention.
|
|
Body Fat Percentage
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Total body fat measured by digital scale (Tanita BC-533).
|
Baseline and after 4 months of Zumba intervention.
|
|
Waist Circumference
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Measured at the narrowest point between the rib cage and iliac crest using a tape measure.
|
Baseline and after 4 months of Zumba intervention.
|
|
Waist-Hip Ratio
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Calculated by dividing waist circumference by hip circumference.
|
Baseline and after 4 months of Zumba intervention.
|
|
Hip Circumference
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Measured at the widest point of the hips using a tape measure.
|
Baseline and after 4 months of Zumba intervention.
|
|
Prolactin
Time Frame: Baseline and after 4 months of the intervention.
|
Serum prolactin concentration (ng/mL).
|
Baseline and after 4 months of the intervention.
|
|
Testosterone
Time Frame: Baseline and after 4 months of the intervention.
|
Serum testosterone concentration (ng/dL).
|
Baseline and after 4 months of the intervention.
|
|
Cortisol
Time Frame: Baseline and after 4 months of the intervention.
|
Serum cortisol concentration (µg/dL).
|
Baseline and after 4 months of the intervention.
|
|
Progesterone
Time Frame: Baseline and after 4 months of the intervention.
|
Serum progesterone concentration (ng/mL).
|
Baseline and after 4 months of the intervention.
|
|
Estradiol
Time Frame: Baseline and after 4 months of the intervention.
|
Serum estradiol concentration (pg/mL).
|
Baseline and after 4 months of the intervention.
|
|
Follicle-Stimulating Hormone (FSH)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum FSH concentration (mIU/mL).
|
Baseline and after 4 months of the intervention.
|
|
Luteinizing Hormone (LH)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum LH concentration (mIU/mL).
|
Baseline and after 4 months of the intervention.
|
|
Thyroid Stimulating Hormone (TSH)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum TSH concentration (µIU/mL).
|
Baseline and after 4 months of the intervention.
|
|
Free Thyroxine (FT4)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum free T4 concentration (ng/dL).
|
Baseline and after 4 months of the intervention.
|
|
Parathyroid Hormone (PTH)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum PTH concentration (pg/mL).
|
Baseline and after 4 months of the intervention.
|
|
Total Cholesterol
Time Frame: Baseline and after 4 months of the intervention.
|
Serum total cholesterol concentration (mg/dL).
|
Baseline and after 4 months of the intervention.
|
|
High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline and after 4 months of the intervention.
|
Serum HDL cholesterol concentration (mg/dL).
|
Baseline and after 4 months of the intervention.
|
|
Low-Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline and after 4 months of the intervention.
|
Serum LDL cholesterol concentration (mg/dL).
|
Baseline and after 4 months of the intervention.
|
|
Triglycerides
Time Frame: Baseline and after 4 months of the intervention.
|
Serum triglyceride concentration (mg/dL).
|
Baseline and after 4 months of the intervention.
|
|
C-Reactive Protein (CRP)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum CRP concentration (mg/L).
|
Baseline and after 4 months of the intervention.
|
|
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline and after 4 months of the intervention.
|
ESR measured in mm/hr.
|
Baseline and after 4 months of the intervention.
|
|
Complete Blood Count (CBC)
Time Frame: Baseline and after 4 months of the intervention.
|
Includes neutrophils, lymphocytes, monocytes, eosinophils, basophils (cells/µL).
|
Baseline and after 4 months of the intervention.
|
|
Alanine Aminotransferase (ALT)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum ALT concentration measured in U/L.
|
Baseline and after 4 months of the intervention.
|
|
Aspartate Aminotransferase (AST)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum AST concentration measured in U/L.
|
Baseline and after 4 months of the intervention.
|
|
Alkaline Phosphatase (ALP)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum ALP concentration measured in U/L.
|
Baseline and after 4 months of the intervention.
|
|
Gamma-Glutamyl Transferase (GGT)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum GGT concentration measured in U/L.
|
Baseline and after 4 months of the intervention.
|
|
Lactate Dehydrogenase (LDH)
Time Frame: Baseline and after the 4 months of the intervention.
|
Serum LDH concentration measured in U/L.
|
Baseline and after the 4 months of the intervention.
|
|
Gamma-Glutamyl Transferase (GGT)
Time Frame: Baseline and after the 4 months of the intervention.
|
Serum GGT concentration measured in U/L.
|
Baseline and after the 4 months of the intervention.
|
|
Bilirubin Total
Time Frame: Baseline and after the 4 months of the intervention.
|
Total serum bilirubin concentration measured in mg/dL.
|
Baseline and after the 4 months of the intervention.
|
|
Bilirubin Direct
Time Frame: Baseline and after the 4 months of the intervention.
|
Direct (conjugated) serum bilirubin concentration measured in mg/dL.
|
Baseline and after the 4 months of the intervention.
|
|
Creatinine
Time Frame: Baseline and after 4 months of the intervention.
|
Serum creatinine concentration measured in mg/dL, indicator of kidney function.
|
Baseline and after 4 months of the intervention.
|
|
Urea
Time Frame: Baseline and after 4 months of the intervention.
|
Serum urea concentration measured in mg/dL, indicator of kidney function.
|
Baseline and after 4 months of the intervention.
|
|
Uric Acid
Time Frame: Baseline and after 4 months of the intervention.
|
Serum uric acid concentration measured in mg/dL, indicator of kidney function.
|
Baseline and after 4 months of the intervention.
|
|
Sodium (Na)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum sodium concentration measured in mmol/L.
|
Baseline and after 4 months of the intervention.
|
|
Potassium (K)
Time Frame: Baseline and after 4 months of the intervention.
|
Serum potassium concentration measured in mmol/L.
|
Baseline and after 4 months of the intervention.
|
|
Calcium (Ca)
Time Frame: Baseline and after 4 months of training.
|
Serum calcium concentration measured in mg/dL.
|
Baseline and after 4 months of training.
|
|
Magnesium (Mg)
Time Frame: Baseline and after 4 months of training.
|
Serum magnesium concentration measured in mg/dL.
|
Baseline and after 4 months of training.
|
|
Phosphate (PO₄)
Time Frame: Baseline and after 4 months of training.
|
Serum phosphate concentration measured in mg/dL.
|
Baseline and after 4 months of training.
|
|
Creatine Phosphokinase (CPK)
Time Frame: Baseline and after 4 months of training.
|
Serum CPK concentration measured in U/L, indicator of muscle damage.
|
Baseline and after 4 months of training.
|
|
Lactate Dehydrogenase (LDH)
Time Frame: Baseline and after 4 months of training.
|
Serum LDH concentration measured in U/L, indicator of muscle and tissue damage.
|
Baseline and after 4 months of training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Heart Rate
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Measured using automated device (Omron BP652).
|
Baseline and after 4 months of Zumba intervention.
|
|
Blood Pressure (Systolic and Diastolic)
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Measured using an automated arm cuff (Omron BP652).
|
Baseline and after 4 months of Zumba intervention.
|
|
6-Minute Walk Test (6MWT) Distance
Time Frame: Baseline and after 4 months of Zumba intervention.
|
Distance walked in 6 minutes on a 30-meter straight corridor.
|
Baseline and after 4 months of Zumba 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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HORMONE-2025
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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