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临床试验/NCT05625945
NCT05625945已完成不适用

Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
1
主要终点
Sedentary time

研究概览

简要总结

Rationale: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS).

Objective: To identify predictors for SAMS in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.

详细描述

Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS). Physical activity may exacerbate SAMS, producing decreased physical activity levels or statin nonadherence. However, it is unknown if daily activity patterns differ between symptomatic and asymptomatic statin users.

In this cross-sectional observational study the investigators will assess if physical activity levels and sedentary time differ between symptomatic and asymptomatic statins users. Secondly, questionnaires will be used to assess predictors of SAMS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mentally able to give informed consent
  • Statin treatment for at least 3 months

排除标准

  • Known hereditary muscle defect
  • Known mitochondrial disease
  • Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)

结局指标

主要结局

Sedentary time

时间窗: during 1 week

Sedentary time (min/day) will be assessed using the activPAL3 micro monitor

Physical activity

时间窗: during 1 week

Physical activity (min/day) will be assessed using the activPAL3 micro monitor

次要结局

  • Predictors of statin-associated muscle complaints (SAMS)(1 moment (cross-sectional))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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