School of Physical Education, Sichuan Normal University
Chengdu, Sichuan, 610101, China
NCT Number: NCT06985550
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.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
Chengdu, Sichuan, 610101, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Total cholesterol ≥ 200 mg/dL Low-density lipoprotein cholesterol ≥ 130 mg/dL Triglycerides ≥ 150 mg/dL High-density lipoprotein cholesterol < 50 mg/dL
Exclusion criteria
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.
Only daily activities are included.
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.
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.
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.
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
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.
Time frame: From baseline through the end of the 12-week intervention period
Anxiety symptoms will be evaluated using the GAD-7, a validated self-report scale assessing the frequency of anxiety-related symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), with a total score range of 0-21. Higher scores indicate greater anxiety severity.
Time frame: From baseline through the end of the 12-week intervention period
Depressive symptoms will be assessed using the PHQ-9, a widely used 9-item self-report measure based on DSM-IV criteria. Participants rate the frequency of symptoms over the past two weeks. Scores range from 0 to 27, with higher scores indicating more severe depression.
Time frame: From baseline through the end of the 12-week intervention period
Mood state will be measured using the Profile of Mood States (POMS), a 65-item self-report questionnaire that evaluates six mood dimensions: tension, depression, anger, vigor, fatigue, and confusion. Scores are combined to generate a total mood disturbance score.
Time frame: From baseline through the end of the 12-week intervention period
Exercise motivation will be measured using the BREQ-3, which evaluates different types of motivational regulation along the self-determination continuum, including intrinsic motivation, identified regulation, introjected regulation, external regulation, and amotivation. The scale uses a 5-point Likert response format.
Time frame: From baseline through the end of the 12-week intervention period
Global cognitive function will be assessed using the MoCA, a validated screening tool for mild cognitive impairment. The MoCA evaluates attention, memory, language, executive function, visuospatial skills, and orientation. The maximum score is 30, with scores below 26 indicating possible cognitive impairment.
Gdansk University of Physical Education and Sport
Other
Acronym: MEP&DL
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