Strength Training Effects on Musculoskeletal Health, Melatonin, Rest-activity Rhythms and Quality of Life: Muscle:Time Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Bone marker activity-bone resorption
研究概览
简要总结
The objective here is to assess the efficacy of variable resistance muscle training on bone, sleep parameters and quality of life in healthy populations of men and women age 30 or older.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 years or older (males or females)
- •Baseline strength (e.g., can lift an office chair with no problems)
- •Be willing to participate in a 6-month RCT
- •Be willing to conduct daily muscle training exercises
- •Be willing to maintain a food diary
- •Be willing to consume ~2.2g/kg body weight daily
- •Be willing to submit specimens and conduct tests 3 times over 6 months (0, 3 and 6 months)
排除标准
- •those who consume vegan or vegetarian diets
- •people with conditions like hypertension and uncontrolled non-medicated blood pressure; cardiovascular disease/heart failure (e.g., arrhythmias, unstable angina, congestive heart failure)
- •drugs that may increase fall risk or make dizzy (e.g., antidepressants, anti-seizure drugs)
- •muscle disease (e.g., myasthenia gravis, myopathy, myositis)
- •active hernia
- •pregnancy
- •muscle atrophy (e.g., Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), ALS)
- •neuro degenerative disease
- •limited mobility
- •those who consume proteins supplements.
- •Individuals who have implanted pacemakers or defibrillators
- •People who suffer from: Marfan syndrome, migraine, hyperparathyroidism, metastatic bone disease, multiple myeloma
- •chronic steroid use
- •individuals with restrictions to movement and exercise
研究组 & 干预措施
The effect of exercise A on musculoskeletal health
干预措施: Muscle Strength Training (Device)
The effect of exercise B on musculoskeletal health
干预措施: Muscle Strength Training (Device)
结局指标
主要结局
Bone marker activity-bone resorption
时间窗: 0-6 months
Urinary CTx levels will be assessed at baseline (month 0) and month 6. The Effect of muscle strengthening on changes in Human Type 1 Collagen C-telopeptide (CTx) levels from baseline to month 6, will be compared within and between groups at 6 mos.
Hormone levels-Cortisol
时间窗: 0-6 months
Urinary cortisol levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in cortisol levels will be assessed at baseline and then compared within and between groups at month 6.
Rest-activity rhythms
时间窗: 0-6 months
Rest activity rhythms will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in rest-activity rhythms will be assessed at baseline and then compared within and between groups at month 6.
Body Circumference
时间窗: 0-6 months
Total body circumference will be measured by Army Body Fat Calculator at baseline (month 0) and month 6. Body circumference, expressed as percentage change from baseline to month 6, will be compared within and between groups at 6 mos.
Lean Body Mass
时间窗: 0-6 months
Muscle measurements and fat composition will be assessed by Tanita at baseline (month 0) and month 6. Muscle mass, expressed as percentage change from baseline to month 6, will be compared within and between groups at 6 mos.
Bone marker activity-bone formation
时间窗: 0-6 months
Urinary P1NP levels will be assessed at baseline (month 0) and month 6. The Effect of muscle strengthening on changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels from baseline will be compared within and between groups at 6 mos.
Functional test 1 to assess musculoskeletal strength
时间窗: 0-6 months
Functional-Timed Up and Go Test will assess musculoskeletal strength at baseline (month 0) and month 6. Timed up-and-go times, expressed as change from baseline to month 6, will be compared within and between groups at 6 mos.
Functional test 2 to assess musculoskeletal strength
时间窗: 0-6 months
Functional-Sit-to-Stand Test will assess musculoskeletal strength at baseline (month 0) and month 6. Functional Sit-to-stand times, expressed as change from baseline to month 6, will be compared within and between groups at 6 mos.
Ratio of bone resorption to bone formation
时间窗: 0-6 months
Urinary CTx:P1NP levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in the ratio of CTx to P1NP will be assessed at baseline and then compared within and between groups at month 6.
Melatonin
时间窗: 0-6 months
Salivary Melatonin levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in melatonin rhythms will be assessed at baseline and then compared within and between groups at month 6.
Hormone levels-Testosterone
时间窗: 0-6 months
Urinary testosterone levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in testosterone levels will be assessed at baseline and then compared within and between groups at month 6.
Inflammatory Marker
时间窗: 0-6 months
Urinary C-reactive protein levels will be assessed at baseline (month 0) and then at month 6. The effect of muscle strengthening on changes in CRP will be assessed at baseline and then compared within and between groups at month 6.
次要结局
未报告次要终点