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

Not Applicable

• Conditions: Coronary Disease; Coronary Artery Disease
• Interventions: Other: Resistance training with vascular occlusion

• Registration Number: NCT03087292
• Lead Sponsor: University Medical Centre Ljubljana

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.)

Study Timeline

• Study Start: 2017-02-27
• Status Verified: 2017-03
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance training group	Resistance training with vascular occlusion	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.

Primary Outcome Measures

Name	Time	Method
Change in maximal strength	4 weeks, 8 weeks	Determined with one repetition maximum test on leg extension machine (kg)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Centre; 🇸🇮 Ljubljana, Slovenia