DyslipaemiaMEP&DLNCT06985550
Effect of Adding Additional Elastic Band Resistance Training to Waltz Dance on Dyslipidemia in Middle-aged and Elderly Women: a Randomized Controlled Trial
A study testing Multicomponent Exercise and daily activity in people with Dyslipaemia, run by Gdansk University of Physical Education and Sport at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Dyslipaemia
- What is being tested?
- Multicomponent Exercise and daily activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
School of Physical Education, Sichuan Normal University
Chengdu, Sichuan, 610101
About this study
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
- Being tested
- Multicomponent Exercise, daily activity
- Keywords
- Dyslipaemia, Multicomponent Exercise, Waltz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent ExerciseBehavioural
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.
daily activityOther
Only daily activities are included.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Exercise |
| Control group | Other | Only daily activities are included. Receives: Other: daily activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline through the end of the 12-week intervention period
Secondary outcomes (7)
Systolic and Diastolic Blood Pressure (SBP, DBP)
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.
Measured: From baseline through the end of the 12-week intervention period
Cardiorespiratory Fitness (Estimated VO₂max via 6-Minute Walk Test)
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.
Measured: From baseline through the end of the 12-week intervention period
Vascular Function (Pulse Wave Velocity [PWV], Ankle-Brachial Index [ABI])
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.
Measured: From baseline through the end of the 12-week intervention period
Body Composition
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.
Measured: From baseline through the end of the 12-week intervention period
Bone Mineral Density (BMD)
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.
Measured: From baseline through the end of the 12-week intervention period
Static Balance
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.
Measured: From baseline through the end of the 12-week intervention period
Dynamic Balance
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.
Measured: From baseline through the end of the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start20 May 2025
- Primary completion20 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiedan Luo, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985550
- Sponsor's protocol ID
- AWFiS/2025_4_JL
- Acronym
- MEP&DL
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The dataset will remain confidential in accordance with ethical and regulatory requirements to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Additional Elastic Band Resistance Training to Waltz Dance on Dyslipidemia in Middle-aged and Elderly Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06985550
- Acronym / sponsor ID
- MEP&DL / AWFiS/2025_4_JL
- Conditions
- Dyslipaemia
- Keywords
- Dyslipaemia, Multicomponent Exercise, Waltz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Multicomponent ExerciseParticipants 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. |
| Control group | Other | Other: daily activityOnly daily activities are included. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent ExerciseParticipants 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. | Behavioural | Exercise group |
| daily activityOnly daily activities are included. | Other | Control group |
Primary outcome
Total Cholesterol (TC) Level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Systolic and Diastolic Blood Pressure (SBP, DBP)
Time frame: From baseline through the end of the 12-week intervention period
Cardiorespiratory Fitness (Estimated VO₂max via 6-Minute Walk Test)
Time frame: From baseline through the end of the 12-week intervention period
Vascular Function (Pulse Wave Velocity [PWV], Ankle-Brachial Index [ABI])
Time frame: From baseline through the end of the 12-week intervention period
Body Composition
Time frame: From baseline through the end of the 12-week intervention period
Bone Mineral Density (BMD)
Time frame: From baseline through the end of the 12-week intervention period
Static Balance
Time frame: From baseline through the end of the 12-week intervention period
Dynamic Balance
Time frame: From baseline through the end of the 12-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The dataset will remain confidential in accordance with ethical and regulatory requirements to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise and daily activity in people with Dyslipaemia, run by Gdansk University of Physical Education and Sport at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (TC) Level (time frame: From baseline through the end of the 12-week intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.