NCT07061249

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 23, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

Waltz DanceCardiopulmonary FitnessLipid MetabolismNon-pharmacological InterventionAging

Outcome Measures

Primary Outcomes (4)

  • Total Cholesterol (TC) Level

    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.

    From enrollment to the end of treatment at 12 weeks

  • Triglycerides (TG) Level

    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.

    From enrollment to the end of treatment at 12 weeks

  • High-Density Lipoprotein Cholesterol (HDL-C) Level

    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.

    From enrollment to the end of treatment at 12 weeks

  • Low-Density Lipoprotein Cholesterol (LDL-C) Level

    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.

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

  • Systolic and Diastolic Blood Pressure and Pulse Pressure (mmHg)

    From enrollment to the end of treatment at 12 weeks

  • Pulse Wave Velocity (m/s)

    From enrollment to the end of treatment at 12 weeks

  • Ankle-Brachial Index (ABI)

    From enrollment to the end of treatment at 12 weeks

  • Cardiorespiratory Fitness - Maximal Oxygen Uptake (VO2max)

    From enrollment to the end of treatment at 12 weeks

  • Peak Exercise Heart Rate (bpm)

    From enrollment to the end of treatment at 12 weeks

Other Outcomes (8)

  • Weight

    From enrollment to the end of treatment at 12 weeks

  • Bone Mineral Density (BMD)

    From enrollment to the end of treatment at 12 weeks

  • Body Mass Index (BMI)

    From enrollment to the end of treatment at 12 weeks

  • +5 more other outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants in this arm will receive a structured Waltz dance intervention as moderate-intensity aerobic exercise. The program consists of 3 supervised sessions per week for 12 weeks, each lasting 105 minutes. Each session includes a 5-minute warm-up, 50 minutes of solo and partner Waltz practice, a 5-minute rest, 40 minutes of choreographed combinations, and a 5-minute cool-down. The dance routines are progressive and designed to improve cardiovascular fitness, coordination, and balance. Exercise intensity is maintained at 50-70% of estimated maximum heart rate, with music tempo and movement complexity adjusted as needed. Physical activity is monitored using accelerometers to ensure target intensity is achieved.

Behavioral: Waltz Dance

Control group

NO INTERVENTION

Only daily activities are included.

Interventions

Waltz DanceBEHAVIORAL

Participants in this arm will receive a structured Waltz dance intervention as moderate-intensity aerobic exercise. The program consists of 3 supervised sessions per week for 12 weeks, each lasting 105 minutes. Each session includes a 5-minute warm-up, 50 minutes of solo and partner Waltz practice, a 5-minute rest, 40 minutes of choreographed combinations, and a 5-minute cool-down. The dance routines are progressive and designed to improve cardiovascular fitness, coordination, and balance. Exercise intensity is maintained at 50-70% of estimated maximum heart rate, with music tempo and movement complexity adjusted as needed. Physical activity is monitored using accelerometers to ensure target intensity is achieved.

Exercise group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants aged between 45 and 65 years.
  • 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).
  • Sedentary lifestyle (less than 60 minutes of structured physical activity per week in the last 6 months).
  • Able to participate safely in moderate-intensity exercise as confirmed by a medical evaluation.
  • Willing to participate in a 12-week supervised exercise program, 3 times per week.
  • Able to understand study procedures and provide written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 11, 2025

Study Start

July 5, 2025

Primary Completion

October 5, 2025

Study Completion

October 10, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. The dataset will remain confidential in accordance with ethical and regulatory requirements to protect participant privacy.