Effects of a 12-Week Waltz Dance Intervention on Cardiovascular Health in Women Aged 45-65 With Dyslipidemia

Not Applicable

Not yet recruiting

• Conditions: Dyslipidemia; Cardiopulmonary Fitness

• Registration Number: NCT07061249
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

The goal of this clinical trial is to learn whether Waltz dance can improve cardiometabolic and bone health in sedentary women aged 45-65 with abnormal lipid levels. The main questions it aims to answer are:

Can Waltz dance improve blood lipid profiles, including total cholesterol, triglycerides, HDL-C, and LDL-C? Can it improve body composition, cardiorespiratory fitness, vascular function, and bone mineral density? Researchers will compare a Waltz dance group with a control group that maintains their usual lifestyle to see if the dance intervention leads to better health outcomes.

Participants will:

Attend supervised Waltz dance classes three times a week for 12 weeks, each session lasting 105 minutes.

Complete physical tests and blood draws before and after the program to measure changes in lipid levels, body composition, fitness, and bone density.

Wear an accelerometer to monitor energy expenditure and physical activity during the program.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study Start: 2025-07-05
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2025-10-05
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Female participants aged between 45 and 65 years.
2. Diagnosed with dyslipidemia (based on clinical lipid profile: TC ≥ 6.2 mmol/L, TG ≥ 2.3 mmol/L, LDL-C ≥ 4.1 mmol/L, or HDL-C < 1.0 mmol/L).
3. Sedentary lifestyle (less than 60 minutes of structured physical activity per week in the last 6 months).
4. Able to participate safely in moderate-intensity exercise as confirmed by a medical evaluation.
5. Willing to participate in a 12-week supervised exercise program, 3 times per week.
6. Able to understand study procedures and provide written informed consent.

Exclusion Criteria

1. Diagnosis of cardiovascular disease requiring medical supervision during exercise (e.g., unstable angina, recent myocardial infarction).
2. Severe musculoskeletal disorders (e.g., advanced osteoarthritis, recent fractures) limiting mobility or physical activity.
3. Neurological or cognitive disorders affecting motor function or communication.
4. Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at rest).
5. Diagnosed osteoporosis with high fracture risk (T-score ≤ -2.5 and history of fragility fractures).
6. Any endocrine disorder that significantly affects lipid metabolism (e.g., uncontrolled thyroid disease, Cushing's syndrome).
7. Participation in structured exercise or dance programs within the past 12 months.
8. Current use of medications significantly affecting lipid levels (e.g., high-dose statins) unless dose has been stable for at least 3 months.
9. Any condition judged by the investigator to interfere with safe participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Cholesterol (TC) Level	From enrollment to the end of treatment at 12 weeks	Total cholesterol (TC) levels will be measured using fasting venous blood samples collected at baseline and after 12 weeks of intervention. Blood will be drawn in the morning after at least 8 hours of fasting. Serum will be analyzed in a certified laboratory using standard enzymatic colorimetric assays. TC is expressed in milligrams per deciliter (mg/dL). Elevated TC is a known risk factor for cardiovascular disease. Changes from baseline to post-intervention will be calculated.
Triglycerides (TG) Level	From enrollment to the end of treatment at 12 weeks	Triglyceride (TG) levels will be assessed through fasting blood samples taken before and after the 12-week intervention. Samples will be processed using standardized laboratory techniques. TG is measured in mg/dL and high levels are associated with increased risk for metabolic and cardiovascular conditions. This outcome measures the change in TG levels between baseline and the end of the study.
High-Density Lipoprotein Cholesterol (HDL-C) Level	From enrollment to the end of treatment at 12 weeks	HDL-C will be measured in serum obtained from fasting venous blood samples collected at baseline and 12 weeks. HDL-C is commonly known as "good" cholesterol due to its protective effect against cardiovascular disease. Standard enzymatic methods will be used for quantification. The change in HDL-C from baseline to post-intervention will be analyzed.
Low-Density Lipoprotein Cholesterol (LDL-C) Level	From enrollment to the end of treatment at 12 weeks	LDL-C will be measured from fasting blood samples collected at the beginning and end of the 12-week intervention. LDL-C, often referred to as "bad" cholesterol, is a key risk factor for atherosclerosis and cardiovascular disease. The value will be determined using direct measurement or calculation by the Friedewald formula. Results will be reported in mg/dL, and changes from baseline to week 12 will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Systolic and Diastolic Blood Pressure and Pulse Pressure (mmHg)	From enrollment to the end of treatment at 12 weeks	Resting systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure (PP = SBP - DBP) will be measured using an automated upper-arm blood pressure monitor (e.g., Omron HEM-7136). Participants will rest quietly in a seated position for at least 5 minutes before three measurements are taken on the right arm. The average of the three readings will be recorded.
Pulse Wave Velocity (m/s)	From enrollment to the end of treatment at 12 weeks	Carotid-femoral pulse wave velocity (cfPWV), an indicator of arterial stiffness and vascular function, will be measured using a validated device (e.g., Complior Analyse). Measurements will be taken while participants are in the supine position after 10 minutes of rest. Higher values indicate increased arterial stiffness.
Ankle-Brachial Index (ABI)	From enrollment to the end of treatment at 12 weeks	ABI is calculated as the ratio of the systolic blood pressure at the ankle (posterior tibial artery) to that in the arm (brachial artery), using a handheld Doppler ultrasound device. Measurements will be taken bilaterally (left and right sides), and the lower of the two values will be used for analysis.; ABI values typically range from 0.00 to 2.00, with higher scores indicating better arterial perfusion.; Values below 0.90 may indicate peripheral arterial disease (PAD), while values above 1.30 may suggest arterial stiffness or calcification.
Cardiorespiratory Fitness - Maximal Oxygen Uptake (VO2max)	From enrollment to the end of treatment at 12 weeks	VO2max will be assessed via a graded exercise treadmill test using the Bruce protocol. Participants will wear a metabolic analyzer (e.g., Cortex MetaLyzer 3B) to measure oxygen consumption. The highest VO2 achieved before exhaustion will be recorded.
Peak Exercise Heart Rate (bpm)	From enrollment to the end of treatment at 12 weeks	Heart rate at maximal effort during the Bruce treadmill test will be continuously monitored using a chest-worn heart rate monitor (e.g., Polar H10). The peak value during the test will be used for analysis.