NCT06391606已完成不适用
Effect of Coenzyme Q10 on Physical Performance in Elderly Patients With Statin-associated Asthenia: a Double-blind, Randomized, Placebo-controlled Clinical Trial
University of Bologna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effect on handgrip strength
研究概览
简要总结
This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effects of supplementation with CoQ10 phytosome on physical performance in older adults with self-reported statin-associated asthenia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65-80 years of age
- •treatment for >6 months with statin monotherapy (i.e. enrolled individuals were asked to be on the same statin at the same dosage for >6 months)
- •statin-associated asthenia for >3 months
排除标准
- •serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
- •orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia
- •obesity (body mass index (BMI)> 30 Kg/m2)
- •known gastrointestinal disorders potentially affecting the absorption of CoQ10
结局指标
主要结局
Effect on handgrip strength
时间窗: 8 weeks
We evaluated the effect on handgrip strength after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. A hand-held dynamometer was used to assess handgrip strength. Measurements were assessed according to the International standard protocols, and obtained after participants performed one familiarization trial with both hands.
次要结局
- Effect on handgrip strength(4 weeks)
- Effect on 2-minute step test(8 weeks)
- Effect on statin-associated asthenia(8 weeks)
- Effect on 1-min sit-to-stand repetitions(8 weeks)
研究者
Claudio Borghi
Prof. Dr.
University of Bologna
研究点 (2)
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