Clinical trial NCT06985550: Effects of a Multicomponent Exercise Program Incorporating Waltz Dance on Postmenopausal Women With Dyslipidemia: A Randomized Controlled Trial
Official title: Effects of a Multicomponent Exercise Program Incorporating Waltz Dance on Postmenopausal Women With Dyslipidemia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyslipaemia
Keywords: Dyslipaemia
Multicomponent Exercise
Postmenopausal women
Waltz
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Cholesterol (TC) Level
timeFrame: From baseline through the end of the 12-week intervention period
measure: Triglycerides (TG) Level
timeFrame: From baseline through the end of the 12-week intervention period
measure: High-Density Lipoprotein Cholesterol (HDL-C) Level
timeFrame: From baseline through the end of the 12-week intervention period
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Level
timeFrame: From baseline through the end of the 12-week intervention period
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure (SBP, DBP)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Cardiorespiratory Fitness (Estimated VO₂max via 6-Minute Walk Test)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Vascular Function (Pulse Wave Velocity [PWV], Ankle-Brachial Index [ABI])
timeFrame: From baseline through the end of the 12-week intervention period
measure: Heart Rate Variability (HRV)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Body Composition
timeFrame: From baseline through the end of the 12-week intervention period
measure: Bone Mineral Density (BMD)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Static Balance
timeFrame: From baseline through the end of the 12-week intervention period
measure: Dynamic Balance
timeFrame: From baseline through the end of the 12-week intervention period
measure: Resting Heart Rate (RHR)
timeFrame: From baseline through the end of the 12-week intervention period
Other outcomes:
measure: Anxiety - Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Depression - Patient Health Questionnaire-9 (PHQ-9)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Mood State - Profile of Mood States (POMS)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Exercise Motivation - Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Cognitive Function - Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline through the end of the 12-week intervention period
measure: Executive Function - Trail Making Test A & B (TMT-A, TMT-B)
timeFrame: From baseline through the end of the 12-week intervention period
Locations:
city: Chengdu
country: China
facility: School of Physical Education, Sichuan Normal University
state: Sichuan
Study officials:
References: