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临床试验/NCT07180485
NCT07180485尚未招募不适用

The Effectiveness of Whole Body Vibration Training in Improving Brain Activity, Bone Mineral Density, Quality of Life, and Biomarkers for the Older People With Dynapenic Abdominal Obesity

Dalin Tzu Chi General Hospital0 个研究点目标入组 120 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
blood tests

研究概览

简要总结

This study focuses on whole body vibration training (WBVT), a form of neuromuscular training that uses mechanical vibrations. WBVT has been shown to improve muscle function, bone mineral density, and quality of life. While some benefits have been observed in the elderly population, there remains a research gap concerning its effectiveness in older adults with dynapenic abdominal obesity. Therefore, the findings of this study will provide new evidence for health interventions targeting this specific group.

This research targets outpatients aged 65 and above who meet the criteria for dynapenic abdominal obesity. It aims to evaluate the effects of WBVT on brain activity, osteoporosis, quality of life, and biological markers. The study period is from February 1, 2025, to January 31, 2027, with a planned sample size of 120 participants, equally divided into an experimental group and a control group (60 participants each).

详细描述

The purpose of this study is to investigate the effects of whole body vibration training on older adults with dynapenic abdominal obesity in the following areas:

Brain activity: Changes in serum levels of brain-derived neurotrophic factor (BDNF).

Bone mineral density: Measured using dual-energy X-ray absorptiometry (DXA).

Quality of life: Assessed through questionnaires covering improvements in physical health, mental well-being, and social functioning.

Biomarkers: Changes in levels of total cholesterol, high- and low-density lipoprotein cholesterol, C-reactive protein (CRP), and glycated hemoglobin (HbA1c).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients aged 65 years or older
  • Diagnosed with dynapenic abdominal obesity
  • Able to understand and follow simple instructions
  • Able to communicate clearly and express their own will
  • Willing to sign the informed consent form

排除标准

  • Inability to communicate in Mandarin or Taiwanese, resulting in inability to participate in research activities
  • Severe visual or hearing impairment that hinders study participation
  • Presence of cognitive impairment, musculoskeletal or severe osteoporosis-related conditions
  • Refusal to sign the informed consent form

结局指标

主要结局

blood tests

时间窗: 24 weeks

Total Cholesterol (TC) Time Frame: Baseline, 3 months, 6 months;Description: Serum total cholesterol level measured in mg/dL. Reference value: \< 200 mg/dL. Triglycerides (TG) Time Frame: Baseline, 3 months, 6 months;Description: Serum triglyceride level measured in mg/dL. Reference value: \< 150 mg/dL. Low-Density Lipoprotein Cholesterol (LDL-C) Time Frame: Baseline, 3 months, 6 months;Description: Serum LDL cholesterol measured in mg/dL. Reference value: \< 130 mg/dL. High-Density Lipoprotein Cholesterol (HDL-C)Time Frame: Baseline, 3 months, 6 months;Description: Serum HDL cholesterol measured in mg/dL. Reference values: \> 40 mg/dL for men, \> 50 mg/dL for women. C-Reactive Protein (CRP)Time Frame: Baseline, 3months, 6 months;Description: Quantitative serum CRP level measured in mg/dL. Normal reference value: 0.3 mg/dL. Glycated Hemoglobin (HbA1c)Time Frame: Baseline, 3 months, 6 months;Description: HbA1c percentage measured in blood. Normal Brain-Derived Neurotroph in pg/mL using

dual-energy X-ray absorptiometry(DXA)

时间窗: 8 months

This study employed dual-energy X-ray absorptiometry (DXA), a widely used and clinically safe method for assessing bone health. The DXA system (brand referenced in previous publications) operates by emitting a low-radiation dose (±10 μSv) X-ray beam to measure the extent of X-ray penetration through body tissues. Based on the absorption data, the device calculates bone mineral density (BMD). Since bones absorb more X-rays and have high penetrability, while fat absorbs less and has low penetrability, DXA effectively differentiates between tissue types. DXA results are typically interpreted using T-scores for BMD. A T-score ≥ -1.0 indicates normal bone density and good skeletal health. A T-score between -2.5 and -1.0 suggests low bone mass (osteopenia), indicating a decreased BMD but not yet at the threshold for osteoporosis. A T-score ≤ -2.5 defines osteoporosis, indicating significantly reduced BMD and a higher risk of fractures. Severe osteoporosis is diagnosed when a T-score ≤ -2.5.

quality of life questionnaire

时间窗: 24 weeks

The Taiwan version of the World Health Organization Quality of Life questionnaire is a shortened version derived from the original 100-item WHOQOL-100 developed by the World Health Organization. Exploratory and confirmatory factor analyses of the questionnaire support a four-domain model consisting of physical health, psychological well-being, social relationships, and environment. The internal consistency (Cronbach's α) of these four domains ranges from 0.70 to 0.77. The questionnaire includes 28 items: one item for overall quality of life, one for general health, seven for physical health, six for psychological well-being, three for social relationships, and eight for environmental factors. The scale uses a 5-point Likert format based on frequency, intensity, capability, and evaluation. Higher scores indicate better quality of life.

次要结局

未报告次要终点

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

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