Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients

Study Overview
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Brief Summary
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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).

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

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

Conditions
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Coronary Disease, Coronary Artery Disease

Intervention / Treatment
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* Other: Resistance training with vascular occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: above 18 years old and below 75 years old coronary heart disease documented with clinical event stable coronary heart disease patients Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistance training group<br>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. | Other: Resistance training with vascular occlusion<br>* Patients will perform unilateral leg extension resistance training with vascular occlusion 2 times per week for a period of 8 weeks. Each training session will consist of 3 sets of 15 repetitions at the intensity of 30% 1 RM with 30 s of rest period between sets.<br>|
| No Intervention: Control group<br>Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal strength | Determined with one repetition maximum test on leg extension machine (kg) | 4 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal voluntary contraction (MVC) | Determined with modified interpolated twitch protocol | 4 and 8 weeks | 
| Changes of flow-mediated dilatation of the brachial artery | Measured with ultrasound in % | 4 weeks, 8 weeks | 
| Change in muscle hypertrophy (muscle thickness) | Measured with ultrasound in mm | 4 and 8 weeks | 
| Change of the value of blood human growth hormon (HGH) | measured in ng/mL | 4 and 8 weeks | 
| Change of the value of testosterone | measured in ng/dL | 4 and 8 weeks | 
| Change of the value of myostatin | measured in ng/mL | 4 and 8 weeks | 
| Change of the value of mechano growth factor (MGF) | measured in ng/mL | 4 and 8 weeks | 
| Change of the value of insulin-like growth factor (IGF-1) | measured in ng/mL | 4 and 8 weeks | 
| Change of the value of epinephrine | measured in pg/mL | 4 and 8 weeks | 
| Change of the value of norepinephrine | measured in pg/mL | 4 and 8 weeks | 
| Change of the value of cortisol | measured in mcg/dL | 4 and 8 weeks | 
| Change in C-reactive protein | measured in mg/L | 4 and 8 weeks | 
| Change in blood pressure prior and after exercise | measured in mmHg | 1-8 week | 
| Change in heat-shock protein (HSP-72) | measured in ng/mL | 4 and 8 weeks | 
| Change in resting and post-exercise heart rate | Measured in beats per min | 4 and 8 weeks | 
| Change of from-the-questionnaire-obtained quality of life | Measured in points | 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction, resistance training, coronary heart disease