Effect of Adding Additional Elastic Band Resistance Training to Waltz Dance on Dyslipidemia in Middle-aged and Elderly Women: a Randomized Controlled Trial

NCT06985550 | Completed

• 1 other identifier: AWFiS/2025_4_JL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: This clinical trial aims to evaluate whether a 12-week multi-component exercise program (combining waltz, resistance training, and agility training) can improve the physical, psychological, and cognitive function of women aged 65 and under with dyslipidemia. Key research questions include: Does this intervention lower lipid levels (e.g., total cholesterol, triglycerides) and improve body composition (e.g., body fat percentage, lean muscle mass)? Compared to a non-exercise control group, does this intervention enhance cardiovascular health, balance, mental health, and cognitive function? Researchers will compare outcomes in the exercise intervention group and the non-exercise control group to assess the effectiveness of the program. Study Procedure: Participants will: attend supervised exercise classes three times a week for 12 weeks (approximately 90 minutes per class). The program includes: - Waltz training (basic steps and choreographed dance movements), - Resistance band exercises (targeting major muscle groups), - Agility and balance training modules. Pre- and post-intervention assessments will include: - Lipid analysis, - Body composition analysis, - Cardiovascular health and balance tests, - Standardized mental health and cognitive assessments.

Conditions

Dyslipaemia

Keywords

Dyslipaemia; Multicomponent Exercise; Waltz

Outcome Measures

Primary Outcomes (4)

• Total Cholesterol (TC) Level

  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.

  From baseline through the end of the 12-week intervention period

• Triglycerides (TG) Level

  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.

  From baseline through the end of the 12-week intervention period

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

  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.

  From baseline through the end of the 12-week intervention period

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

  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.

  From baseline through the end of the 12-week intervention period

Secondary Outcomes (7)

• Systolic and Diastolic Blood Pressure (SBP, DBP)

  From baseline through the end of the 12-week intervention period

• Cardiorespiratory Fitness (Estimated VO₂max via 6-Minute Walk Test)

  From baseline through the end of the 12-week intervention period

• Vascular Function (Pulse Wave Velocity [PWV], Ankle-Brachial Index [ABI])

  From baseline through the end of the 12-week intervention period

• Body Composition

  From baseline through the end of the 12-week intervention period

• Bone Mineral Density (BMD)

  From baseline through the end of the 12-week intervention period

Other Outcomes (5)

• Anxiety - Generalized Anxiety Disorder 7-item scale (GAD-7)

  From baseline through the end of the 12-week intervention period

• Depression - Patient Health Questionnaire-9 (PHQ-9)

  From baseline through the end of the 12-week intervention period

• Mood State - Profile of Mood States (POMS)

  From baseline through the end of the 12-week intervention period

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants in this group will participate in a 12-week multi-component exercise program, three times a week for 90 minutes each time. Each session includes a 5-minute warm-up, 50 minutes of waltz dancing (learning and practicing steps), 30 minutes of resistance band exercises (1-3 sets of 8-16 repetitions at 10-20 grams of maximum resting resistance), and 5 minutes of cool-down stretching. Exercise intensity will gradually increase from 50% to 75% of maximum heart rate (HRmax) (RPE 10-13, METs 2.0-6.0). The program aims to improve lipid profile, body composition, cardiovascular health, balance, mental health, and cognitive function in women aged 65 and under with dyslipidemia.

Behavioral: Multicomponent Exercise

Control group

OTHER

Only daily activities are included.

Other: daily activity

Interventions

daily activity OTHER

Only daily activities are included.

Control group

Multicomponent Exercise BEHAVIORAL

Participants in this group will participate in a 12-week multi-component exercise program, three times a week for 90 minutes each time. Each session includes a 5-minute warm-up, 50 minutes of waltz dancing (learning and practicing steps), 30 minutes of resistance band exercises (1-3 sets of 8-16 repetitions at 10-20 grams of maximum resting resistance), and 5 minutes of cool-down stretching. Exercise intensity will gradually increase from 50% to 75% of maximum heart rate (HRmax) (RPE 10-13, METs 2.0-6.0). The program aims to improve lipid profile, body composition, cardiovascular health, balance, mental health, and cognitive function in women aged 65 and under with dyslipidemia.

Exercise group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 45 to 65 years
• Diagnosis of dyslipidemia defined according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria, meeting at least one of the following:
• Total cholesterol ≥ 200 mg/dL Low-density lipoprotein cholesterol ≥ 130 mg/dL Triglycerides ≥ 150 mg/dL High-density lipoprotein cholesterol \< 50 mg/dL
• Not taking lipid-lowering medications, or on a stable lipid-lowering regimen for at least 3 months prior to enrollment with no anticipated changes during the study period
• Medically cleared to participate in moderate-intensity aerobic and resistance exercise according to American College of Sports Medicine (ACSM) guidelines
• Able and willing to participate in a 12-week supervised exercise intervention
• Provided written informed consent

You may not qualify if:

• History of major cardiovascular events, including myocardial infarction, stroke, or unstable angina
• Diagnosed diabetes with poor glycemic control
• Serious metabolic or endocrine diseases known to affect lipid metabolism (e.g., uncontrolled thyroid disease)
• Serious musculoskeletal, neurological, or orthopedic conditions that may limit safe participation in sports
• Participated in a structured exercise program more than 2 times per week in the past 6 months
• Current hormone replacement therapy or other medications known to significantly affect lipid metabolism
• Cognitive impairment or psychiatric illness that may interfere with study participation or adherence
• Any other medical condition that was deemed by the investigators to compromise the safety of the participants or the integrity of the data

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead

Study Sites (1)

School of Physical Education, Sichuan Normal University

Chengdu, Sichuan, 610101, China

Location

MeSH Terms

Interventions

Activities of Daily Living

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

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: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: May 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 30, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)