Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- AMMI(appendicular muscle mass index)
研究概览
简要总结
The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. The main questions it aims to answer are:
- whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia.
- the changes of these bioindicators that occur in older adults after going through an intensive intervention.
Participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.
Researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident elderly aged 65-90 years old in the district.
- •Voluntary participation in the trial and signing the informed consent form.
排除标准
- •People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
- •People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
- •People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
- •People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
- •Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.
结局指标
主要结局
AMMI(appendicular muscle mass index)
时间窗: baseline and 3 month
Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height\^2 (kg/m\^2).
次要结局
- Lymphocyte count(baseline and 3 month)
- Basal metabolic mass(baseline and 3 month)
- Fat-free mass(baseline and 3 month)
- Albumin(baseline and 3 month)
- Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))(baseline and 3 month)
- Fat mass(baseline and 3 month)
- Five items of blood lipid (triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C))(baseline and 3 month)
研究者
Lijun Yang
Physician in Charge
Suzhou Municipal Hospital