Effects of Milk or Soy Milk Combined With Mild Resistance Exercise on the Muscle Mass and Muscle Strength in Very Old Nursing Home Residents With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- height in meters
研究概览
简要总结
The purpose of this study was determine whether milk or soy milk supplements combined with resistance exercise improved sarcopenia in the elderly. This study was randomized controlled trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of Taipei Veterans General Hospital Su-Ao and Yuanshan Branch from June 2017 to December, 2017. The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30 min/time). After 12 weeks, the anthropometry, sarcopenia index, blood biochemical index, nutrition status index, inflammation index, insulin resistance index, and dietary intake were measured.
详细描述
The anthropometry data included body weight and body fat. The sarcopenia index included appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed. Moreover, blood biochemical index (liver function as ALT, kidney function as creatinine), nutrition status index (prealbumin, 25-hydroxyvitamin D) were also analyzed. The blood hsCRP level was as inflammation index and insulin resistance index included fasting blood sugar, insulin, HbA1c and HOMA-IR. The daily dietary intake were also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≧ 65 years old
- •No allergies to milk and soy milk
- •Sarcopenia cases (AWGS)
- •Active ability
排除标准
- •End-of-life patient or estimated death within six months
- •Last stage of cancer
- •Chronic kidney disease stage 4
结局指标
主要结局
height in meters
时间窗: baseline
Height was measured by height meter
Change from baseline appendicular skeletal muscle mass index at 12 weeks
时间窗: 12 weeks
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.
Change from baseline hand grip at 12 weeks
时间窗: 12 weeks
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
appendicular skeletal muscle mass in kilograms
时间窗: baseline
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Change from baseline appendicular skeletal muscle mass at 6 weeks
时间窗: 6 weeks
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Change from baseline appendicular skeletal muscle mass at 12 weeks
时间窗: 12 weeks
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Change baseline weeks height at 6 weeks
时间窗: 6 weeks
Height was measured by height meter
Change from baseline height at 12 weeks
时间窗: 12 weeks
Height was measured by height meter
appendicular skeletal muscle mass index in kg/m^2
时间窗: baseline
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.
Change from baseline appendicular skeletal muscle mass index at 6 weeks
时间窗: 6 weeks
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.
calf circumferences in centimeter
时间窗: baseline
calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
Change from baseline hand grip at 6 weeks
时间窗: 6 weeks
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
Change from baseline calf circumferences at 6 weeks
时间窗: 6 weeks
calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
Change from baseline calf circumferences at 12 weeks
时间窗: 12 weeks
calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
Change from baseline gait speed at 6 weeks
时间窗: 6 weeks
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
hand grip in kilograms
时间窗: baseline
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
gait speed in meter per second
时间窗: baseline
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
Change from baseline gait speed at 12 weeks
时间窗: 12 weeks
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
次要结局
- Change from baseline blood alanine transaminase activity at 12 weeks(12 weeks)
- Change from baseline blood creatinine level at 12 weeks(12 weeks)
- blood prealbumin level in mg/dL(baseline)
- blood alanine transaminase activity in U/L(baseline)
- Change from baseline blood prealbumin level at 12 weeks(12 weeks)
- Change from baseline blood insulin level at 12 weeks(12 weeks)
- blood 25-hydroxyvitamin D level in ng/mL(baseline)
- Change from baseline blood 25-hydroxyvitamin D level at 12 weeks(12 weeks)
- High sensitive C-reactive protein in mg/dL(baseline)
- blood creatinine level in mg/dL(baseline)
- blood fasting blood sugar in mg/dL(baseline)
- Change from baseline blood fasting blood sugar at 12 weeks(12 weeks)
- blood insulin level in milli-international unit/L(baseline)
- blood HbA1c in percentage(baseline)
- Change from baseline blood HbA1c at 12 weeks(12 weeks)
- Change from baseline High sensitive C-reactive protein at 12 weeks(12 weeks)
- Homeostasis model assessment-insulin resistance index (HOMA-IR)(baseline)
- Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks(12 weeks)
- blood insulin-like growth factor 1 in mg/dL(baseline)
- Change from baseline blood insulin-like growth factor 1 at 12 weeks(12 weeks)
研究者
Jiun-Rong Chen
Professor
Taipei Medical University