Effects of a Multicomponent Exercise Program Incorporating Waltz Dance on Postmenopausal Women With Dyslipidemia: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Dyslipaemia

• Registration Number: NCT06985550
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

Brief Summary:

The goal of this clinical trial is to evaluate whether a 12-week multicomponent exercise program-combining Waltz dance, resistance training, and agility training-can improve physiological, psychological, and cognitive outcomes in postmenopausal women aged ≤65 years with dyslipidemia.

The main research questions are:

Does the intervention reduce blood lipid levels (e.g., total cholesterol, triglycerides) and improve body composition (e.g., fat percentage, lean muscle mass)? Does the intervention enhance cardiovascular fitness, balance, mental well-being, and cognitive function, compared to a no-exercise control group? Researchers will compare outcomes between an exercise intervention group and a non-exercise control group to assess the program's effectiveness.

Study Procedures:

Participants will:

Engage in supervised exercise sessions 3 times per week for 12 weeks (each session lasting \~90 minutes).

Participate in:

* .Waltz dance training (basic steps and choreographed routines),

* Resistance band exercises (targeting major muscle groups),

* Agility and balance training modules

Complete pre- and post-intervention assessments, including:

* Blood lipid profiles,

* Body composition analysis,

* Cardiovascular fitness and balance tests,

* Standardized mental health and cognitive assessments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study Start: 2025-05-20
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-20

Recruitment & Eligibility

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

Inclusion Criteria

1. Age: Postmenopausal women aged ≤65 years at the time of enrollment.

2. Menopausal Status: Natural menopause defined as spontaneous cessation of menstruation for ≥12 consecutive months, excluding menopause due to pathological or surgical causes (e.g., oophorectomy, thyroid disorders).

3. Dyslipidemia: Presence of one or more of the following lipid abnormalities:

   High-density lipoprotein cholesterol (HDL-C) < 1.04 mmol/L Triglycerides (TG) ≥ 1.7 mmol/L Low-density lipoprotein cholesterol (LDL-C) ≥ 3.0 mmol/L Total cholesterol (TC) ≥ 5.18 mmol/L

4. Obesity or Sarcopenic Tendency: Body fat percentage > 30%, as measured by validated body composition analyzer.

5. Physical Capability: No musculoskeletal injuries, physical disabilities, or contraindications to exercise. Participants must be cleared using the Physical Activity Readiness Questionnaire (PAR-Q).

6. Sedentary Lifestyle: Engaging in structured physical activity ≤3 times per week, with each session lasting ≤20 minutes, in the last 6 months.

7. No Recent Weight Control Interventions: No use of weight-loss supplements or engagement in intentional weight loss through diet or exercise in the past year.

8. Voluntary Participation: Willingness to participate in the study and provide written informed consent (Informed Consent Form, ICF).

Exclusion Criteria

1. Metabolic or Endocrine Disorders: History of insulin-dependent diabetes mellitus, untreated or unstable thyroid dysfunction, Cushing's syndrome, or other serious endocrine diseases.

2. Cardiovascular Disease: Uncontrolled hypertension, arrhythmias, congestive heart failure, or a history of myocardial infarction or stroke within the past 6 months.

3. Severe Respiratory Conditions: Chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or any condition significantly limiting exercise tolerance.

4. Neurological Disorders: Parkinson's disease, post-stroke sequelae, moderate to severe cognitive impairment, or Alzheimer's disease.

5. Inflammatory or Autoimmune Diseases: Active rheumatoid arthritis, Crohn's disease, or other chronic inflammatory conditions.

6. Cancer: Diagnosis of any malignancy within the past 5 years.

7. Musculoskeletal Limitations: Diagnosed severe osteoporosis or a history of falls or fractures within the past 6 months.

8. Extremes of Body Mass Index (BMI): BMI ≥35 kg/m² or <18.5 kg/m².

9. Substance Use: Current drug abuse, heavy alcohol consumption (defined as >70 g alcohol/week), or heavy smoking (≥10 cigarettes/day) that cannot be reduced during the study period.

10. Dietary Extremes: Strict vegetarian, ketogenic, or other extreme dietary patterns that may affect metabolic outcomes.

11. Medications:

    Current hormone replacement therapy (e.g., estrogen, testosterone). Use of antidepressants in the past 6 months. Regular use of medications affecting lipid metabolism, bone health, or cardiovascular function (e.g., aspirin, statins, antihypertensive or antidiabetic drugs).

12. Recent Structured Exercise: Participation in structured dance, resistance, or agility training within the past 12 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Cholesterol (TC) Level	From baseline through the end of the 12-week intervention period	Total cholesterol will be measured in fasting venous blood samples (12-hour fast) using an enzymatic colorimetric method with a clinical chemistry analyzer. The result will be reported in mg/dL. Total cholesterol refers to the overall amount of cholesterol in the blood, which includes LDL-C and HDL-C. High levels are associated with increased cardiovascular risk. Blood samples will be collected at baseline and at the end of the 12-week intervention.
Triglycerides (TG) Level	From baseline through the end of the 12-week intervention period	Triglyceride levels will be measured from fasting venous blood samples (12-hour fast) using enzymatic assays with a clinical chemistry analyzer. The result will be reported in mg/dL. Triglycerides are a type of fat found in the blood. Elevated levels are associated with metabolic syndrome and increased risk of heart disease. Blood samples will be collected at baseline and at 12 weeks post-intervention.
High-Density Lipoprotein Cholesterol (HDL-C) Level	From baseline through the end of the 12-week intervention period	HDL-C will be measured from fasting venous blood samples using direct enzymatic assays. HDL-C is often referred to as "good" cholesterol because it helps remove other forms of cholesterol from the bloodstream. Low levels are a risk factor for cardiovascular disease. The result will be reported in mg/dL and assessed at baseline and after the 12-week program.
Low-Density Lipoprotein Cholesterol (LDL-C) Level	From baseline through the end of the 12-week intervention period	LDL-C will be measured using the Friedewald equation or direct measurement (depending on TG level) from fasting venous blood samples. LDL-C is known as "bad" cholesterol because it contributes to plaque buildup in arteries. The result will be reported in mg/dL. Blood samples will be taken at baseline and after the 12-week exercise intervention.

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory Fitness (Estimated VO₂max via 6-Minute Walk Test)	From baseline through the end of the 12-week intervention period	Cardiorespiratory fitness will be estimated using the 6-Minute Walk Test (6MWT), a validated submaximal field test. Participants will be instructed to walk at their fastest safe pace along a 30-meter corridor for 6 minutes. Total distance covered will be used to estimate VO₂max using validated predictive equations adjusted for age and sex. This measure reflects aerobic capacity and endurance.
Systolic and Diastolic Blood Pressure (SBP, DBP)	From baseline through the end of the 12-week intervention period	Resting systolic and diastolic blood pressure will be measured using a validated automatic digital blood pressure monitor (e.g., Omron HEM-907). Participants will be seated quietly for at least 5 minutes prior to measurement. Three readings will be taken at 1-minute intervals on the non-dominant arm, and the average of the last two will be recorded. Blood pressure is expressed in mmHg and interpreted according to international hypertension guidelines.
Vascular Function (Pulse Wave Velocity [PWV], Ankle-Brachial Index [ABI])	From baseline through the end of the 12-week intervention period	Arterial stiffness and peripheral vascular health will be assessed using a validated vascular testing device (e.g., VaSera VS-1500 or equivalent). Pulse Wave Velocity (PWV) measures the speed of arterial pulse propagation and is a marker of arterial stiffness. Ankle-Brachial Index (ABI) is calculated by dividing the systolic blood pressure at the ankle by that at the brachial artery. Both are non-invasive and widely used indicators of cardiovascular health.
Heart Rate Variability (HRV)	From baseline through the end of the 12-week intervention period	Heart rate variability will be measured using a chest-strap heart rate sensor (e.g., Polar H10). Participants will rest in a supine position for 10 minutes, during which R-R intervals will be continuously recorded. HRV will be analyzed using time-domain and frequency-domain parameters (e.g., SDNN, RMSSD, LF/HF) via validated software such as Kubios HRV. HRV reflects autonomic nervous system function and cardiovascular adaptability.
Body Composition	From baseline through the end of the 12-week intervention period	Body composition will be assessed using a validated bioelectrical impedance analysis device (e.g., InBody 720), including body fat percentage, body fat mass, lean body mass, skeletal muscle mass, and body mass index (BMI). Participants will be measured barefoot and in light clothing after an overnight fast, following standard procedures recommended by the manufacturer.
Bone Mineral Density (BMD)	From baseline through the end of the 12-week intervention period	Bone mineral density will be evaluated using an ultrasound bone densitometer (e.g., Sahara Clinical Bone Sonometer), measuring the calcaneal bone (heel). The test is non-invasive, and results will be recorded as T-scores according to WHO criteria.
Static Balance	From baseline through the end of the 12-week intervention period	Static balance will be assessed using the single-leg stance test with eyes closed. The maximum duration (in seconds) the participant can stand unassisted on one leg without touching the ground with the lifted foot will be recorded, up to 60 seconds. Three trials will be conducted and the best result recorded.
Dynamic Balance	From baseline through the end of the 12-week intervention period	Dynamic balance will be measured using the Biodex Balance System SD, performing the Limits of Stability (LOS) test protocol. Participants will stand on a movable platform and shift their center of gravity to targets displayed on a screen. Scores will reflect directional control and stability performance.
Resting Heart Rate (RHR)	From baseline through the end of the 12-week intervention period	Resting heart rate (RHR) will be measured using a validated automated electronic sphygmomanometer (digital blood pressure monitor) after the participant has remained seated and at rest for at least 5 minutes in a quiet room. The measurement will be taken in the morning, avoiding caffeine or exercise at least 2 hours prior. The RHR is defined as the number of heartbeats per minute under resting conditions and is a widely used indicator of cardiovascular health and autonomic function. The lower the RHR (within normal range), the better the indicator of cardiorespiratory fitness.

Trial Locations

Locations (1)

School of Physical Education, Sichuan Normal University; 🇨🇳 Chengdu, Sichuan, China