Clinical trial NCT03087292: Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
Official title: Effect of Low Intensity Resistance Training With Vascular Occlusion on Muscle Hypertrophy, Neuromuscular Adaptations and Selected Cardiovascular Parameters in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Coronary Artery Disease
Keywords: blood flow restriction
resistance training
coronary heart disease
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2017-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Change in maximal strength
timeFrame: 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in maximal voluntary contraction (MVC)
timeFrame: 4 and 8 weeks
measure: Changes of flow-mediated dilatation of the brachial artery
timeFrame: 4 weeks, 8 weeks
measure: Change in muscle hypertrophy (muscle thickness)
timeFrame: 4 and 8 weeks
measure: Change of the value of blood human growth hormon (HGH)
timeFrame: 4 and 8 weeks
measure: Change of the value of testosterone
timeFrame: 4 and 8 weeks
measure: Change of the value of myostatin
timeFrame: 4 and 8 weeks
measure: Change of the value of mechano growth factor (MGF)
timeFrame: 4 and 8 weeks
measure: Change of the value of insulin-like growth factor (IGF-1)
timeFrame: 4 and 8 weeks
measure: Change of the value of epinephrine
timeFrame: 4 and 8 weeks
measure: Change of the value of norepinephrine
timeFrame: 4 and 8 weeks
measure: Change of the value of cortisol
timeFrame: 4 and 8 weeks
measure: Change in C-reactive protein
timeFrame: 4 and 8 weeks
measure: Change in blood pressure prior and after exercise
timeFrame: 1-8 week
measure: Change in heat-shock protein (HSP-72)
timeFrame: 4 and 8 weeks
measure: Change in resting and post-exercise heart rate
timeFrame: 4 and 8 weeks
measure: Change of from-the-questionnaire-obtained quality of life
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
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