Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men
概览
- 阶段
- 4 期
- 干预措施
- Transdermal testosterone gel (Testogel 1% )
- 疾病 / 适应症
- Frailty
- 发起方
- Manchester University NHS Foundation Trust
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Lower limb muscle strength at 6 months
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life
详细描述
Ageing-associated loss of muscle mass and strength is a major cause of physical frailty, disability, morbidity and dependency in the elderly. This is associated with increased falls, fractures, loss of mobility, restricted activities of daily living and increased utilisation of healthcare resources. It is well known that serum testosterone levels fall with advancing age and this may be an important cause for muscle wasting and weakness (sarcopenia). Testosterone replacement increases muscle mass and improves muscle strength in young hypogonadal men. In relatively healthy elderly men, some short-term studies have also shown that testosterone can improve muscle strength. The potential beneficial effects of testosterone supplementation on muscle strength and functional capacity of frail elderly men has so far not been studies and forms the basis of this research. We hypothesise that testosterone supplementation is an effective, safe and economic anabolic intervention in frail elderly men with low circulating testosterone.
研究者
入排标准
入选标准
- •Frail elderly men (as defined by Freid's criteria of frailty)
- •Community - dwelling men aged 65 years and above
- •Total testosterone ≤12.0 nmol/L or calculated free T≤0.25nmol/L
排除标准
- •Carcinoma of prostate
- •Carcinoma of breast
- •PSA \>4ng/mL
- •Severe symptomatic benign prostatic hypertrophy (IPSS \>21)
- •Active liver disease
- •Renal impairment (serum creatinine \>180 mmol/L)
- •Congestive heart failure
- •Unstable ischaemic heart disease
- •Polycythaemia
- •Evidence of systemic disease which may affect muscle/joint function
研究组 & 干预措施
1
Transdermal testosterone gel (Testogel 1% )
干预措施: Transdermal testosterone gel (Testogel 1% )
2
Matched transdermal placebo gel
干预措施: Matched transdermal placebo gel
结局指标
主要结局
Lower limb muscle strength at 6 months
时间窗: 6 months
次要结局
- Upper limb muscle strength at 6 months(6 months)
- Improvement in physical performance(6 months)
- Bone Mineral Density(6 months)
- Quality of life at 6 months(6 months)
- Total and regional lean body mass at 6 months(6 months)