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临床试验/NCT05011643
NCT05011643已完成不适用

The Effects of Statins on Muscle Damage Markers After Moderate-intensity Exercise

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年5月29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
100
试验地点
1
主要终点
Muscle damage markers

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) and elevated markers of skeletal muscle damage in some patients.

Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. If statins also increase muscle damage markers after exercises of moderate intensity is unclear. Symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury, however, previous studies did not differentiate between symptomatic and asymptomatic statin users.

Objective: To compare the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.

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) and elevated markers of skeletal muscle damage in some patients.

Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. However. if statins also increase muscle damage markers after exercises of moderate intensity is unclear. Impaired mitochondrial oxidative function might contribute to SAMS and exercise-induced muscle damage. Several studies showed that statins decrease serum coenzyme Q10 levels, an essential component of the mitochondrial transport chain, but effects on intramuscular coenzyme Q10 levels are inconsistent. The investigators have observed that mitochondrial dysfunction is more pronounced in statin users with SAMS compared to asymptomatic statin users. This suggests that symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury. However, previous studies examining creatine kinase response to exercise did not differentiate between symptomatic and asymptomatic statin users.

In this cross-sectional observational study the investigators will study the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.

The investigators hypothesize that statins will not increase muscle damage markers after moderate-intensity exercise and that higher CoQ10 levels are associated with less exercise-induced muscle damage and muscle complaints.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Known hereditary muscle defect
  • Known mitochondrial disease
  • Diabetes Mellitus
  • Hypo- or hyperthyroidism
  • Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)
  • Coenzyme Q10 supplementation

结局指标

主要结局

Muscle damage markers

时间窗: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)

Change in muscle damage markers (creatine kinase, myoglobin, lactate dehydrogenase, troponin I and BNP) from baseline to post-exercise

次要结局

  • Muscle pain scores(Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day))
  • Muscle strength and fatigue(Baseline (before exercise) and after one day of moderate-intensity walking exercise)
  • Coenzyme Q10 levels(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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