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临床试验/NCT03087292
NCT03087292Unknown不适用

Effect of Low Intensity Resistance Training With Vascular Occlusion on Muscle Hypertrophy, Neuromuscular Adaptations and Selected Cardiovascular Parameters in Patients With Coronary Heart Disease

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change in maximal strength

研究概览

简要总结

In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).

详细描述

Physical activity in patients with coronary heart disease improves health, quality of life, and reduces risk of coronary events, morbidity and mortality. Aerobic training is preferred as a part of cardiac rehabilitation with its well established evidence-based guidelines. On the other hand, the resistance training was first introduced as a part of cardiac rehabilitation just over a decade ago, due to its positive effects on performance, quality of life and muscle hypertrophy and strength. Despite the positive effects of resistance training, there still lacks evidence about its effect on cardiovascular health. Furthermore, guidelines still do not specify the exact training volumes, doses and types of resistance training for patients with coronary heart disease.

In clinical practice, it is often difficult and contraindicated to use near-maximal loads (e.g., in the early stages of cardiac rehabilitation, after sport injury, etc.). Muscle atrophy and weakness often occur rapidly in the affected area due to the effects of trauma (or disease) and inactivity. Consequently, training modalities that promote hypertrophy or counteract atrophy without the use of heavy loads should be of special interest in the rehabilitation of some chronic diseases for which high musculoskeletal forces are contraindicated.

Occlusive strength training with tourniquet cuffs was first used nearly twenty years ago. Studies have shown that low to-moderate intensity (20-50% of 1RM) resistance training with vascular occlusion leads to gains in muscle strength and volume comparable to those seen after conventional heavy resistance training. This effects suggest, that ischemic strength training may be a useful method in rehabilitation and other contexts.

To conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on:

  1. muscle hypertrophy, strength and neuromuscular parameters;
  2. vascular function;
  3. and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •above 18 years old and below 75 years old
  • •coronary heart disease documented with clinical event
  • •stable coronary heart disease patients

排除标准

  • •Unstable phase of coronary heart disease
  • •dysfunction of left ventricle
  • •residual myocardial ischemia
  • •contraindications for physical activity,
  • •intellectual development disorder,
  • •recent dissection of aorta
  • •recent vein thrombolysis

研究组 & 干预措施

Resistance training group

Active Comparator

Patients to be randomly assigned to the "resistance training group" will have resistance training with vascular occlusion 2 times per week for a period of 8 weeks on unilateral leg extension machine. During each training, they will performed 3 sets of 15 repetitions at the intensity of 30% 1 RM (repetition maximum). Each training set will separated by a 30 second rest period.

干预措施: Resistance training with vascular occlusion (Other)

Control group

No Intervention

Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.

结局指标

主要结局

Change in maximal strength

时间窗: 4 weeks, 8 weeks

Determined with one repetition maximum test on leg extension machine (kg)

次要结局

  • Change in maximal voluntary contraction (MVC)(4 and 8 weeks)
  • Changes of flow-mediated dilatation of the brachial artery(4 weeks, 8 weeks)
  • Change in muscle hypertrophy (muscle thickness)(4 and 8 weeks)
  • Change of the value of blood human growth hormon (HGH)(4 and 8 weeks)
  • Change of the value of testosterone(4 and 8 weeks)
  • Change of the value of myostatin(4 and 8 weeks)
  • Change of the value of mechano growth factor (MGF)(4 and 8 weeks)
  • Change of the value of insulin-like growth factor (IGF-1)(4 and 8 weeks)
  • Change of the value of epinephrine(4 and 8 weeks)
  • Change of the value of norepinephrine(4 and 8 weeks)
  • Change of the value of cortisol(4 and 8 weeks)
  • Change in C-reactive protein(4 and 8 weeks)
  • Change in blood pressure prior and after exercise(1-8 week)
  • Change in heat-shock protein (HSP-72)(4 and 8 weeks)
  • Change in resting and post-exercise heart rate(4 and 8 weeks)
  • Change of from-the-questionnaire-obtained quality of life(4 and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Borut Jug

Assistant Professor

University Medical Centre Ljubljana

研究点 (1)

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