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

NCT ID: NCT06985550

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-09-20

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.

Conditions

Dyslipaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise group

Participants in this group will engage in a 12-week supervised multicomponent exercise program, performed 3 times per week, 90 minutes per session. Each session includes a 10-minute warm-up, 40 minutes of Waltz dance (learning and practicing routines), 30 minutes of resistance band exercises (1-3 sets of 8-12 repetitions, using 10-20RM), and a 10-minute cool-down with stretching. Exercise intensity progresses from 50% to 75% of HRmax (RPE 10-13, 2.0-6.0 METs). The program is designed to improve lipid profile, body composition, cardiovascular fitness, balance, mental health, and cognitive function in postmenopausal women aged ≤65 years with dyslipidemia.

Group Type: EXPERIMENTAL

Multicomponent Exercise

Intervention Type: BEHAVIORAL

Participants in this group will engage in a 12-week supervised multicomponent exercise program, performed 3 times per week, 90 minutes per session. Each session includes a 10-minute warm-up, 40 minutes of Waltz dance (learning and practicing routines), 30 minutes of resistance band exercises (1-3 sets of 8-12 repetitions, using 10-20RM), and a 10-minute cool-down with stretching. Exercise intensity progresses from 50% to 75% of HRmax (RPE 10-13, 2.0-6.0 METs). The program is designed to improve lipid profile, body composition, cardiovascular fitness, balance, mental health, and cognitive function in postmenopausal women aged ≤65 years with dyslipidemia.

Control group

Only daily activities are included.

Group Type: OTHER

daily activity

Intervention Type: OTHER

Only daily activities are included.

Interventions

Multicomponent Exercise

Participants in this group will engage in a 12-week supervised multicomponent exercise program, performed 3 times per week, 90 minutes per session. Each session includes a 10-minute warm-up, 40 minutes of Waltz dance (learning and practicing routines), 30 minutes of resistance band exercises (1-3 sets of 8-12 repetitions, using 10-20RM), and a 10-minute cool-down with stretching. Exercise intensity progresses from 50% to 75% of HRmax (RPE 10-13, 2.0-6.0 METs). The program is designed to improve lipid profile, body composition, cardiovascular fitness, balance, mental health, and cognitive function in postmenopausal women aged ≤65 years with dyslipidemia.

Intervention Type: BEHAVIORAL

daily activity

Only daily activities are included.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gdansk University of Physical Education and Sport

OTHER

Sponsor Role: lead

Responsible Party

Jiedan Luo

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Physical Education, Sichuan Normal University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Jiedan luo, PHD

Role: CONTACT

jiedan.luo@awf.gda.pl

+86 18009076626 ext. 48 453312957

Facility Contacts

Kang Zhang, Associate Professor

Role: primary

459132165@qq.com

+86 18981946721

Other Identifiers

AWFiS/2025_4_JL

Identifier Type: -

Identifier Source: org_study_id