Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
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|ClinicalTrials.gov Identifier: NCT03087292|
Recruitment Status : Unknown
Verified March 2017 by Borut Jug, University Medical Centre Ljubljana.
Recruitment status was: Recruiting
First Posted : March 22, 2017
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Coronary Artery Disease||Other: Resistance training with vascular occlusion||Not Applicable|
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.)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||June 15, 2017|
|Estimated Study Completion Date :||June 15, 2017|
Active Comparator: Resistance training group
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
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.
No Intervention: Control group
Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.
- Change in maximal strength [ Time Frame: 4 weeks, 8 weeks ]Determined with one repetition maximum test on leg extension machine (kg)
- Change in maximal voluntary contraction (MVC) [ Time Frame: 4 and 8 weeks ]Determined with modified interpolated twitch protocol
- Changes of flow-mediated dilatation of the brachial artery [ Time Frame: 4 weeks, 8 weeks ]Measured with ultrasound in %
- Change in muscle hypertrophy (muscle thickness) [ Time Frame: 4 and 8 weeks ]Measured with ultrasound in mm
- Change of the value of blood human growth hormon (HGH) [ Time Frame: 4 and 8 weeks ]measured in ng/mL
- Change of the value of testosterone [ Time Frame: 4 and 8 weeks ]measured in ng/dL
- Change of the value of myostatin [ Time Frame: 4 and 8 weeks ]measured in ng/mL
- Change of the value of mechano growth factor (MGF) [ Time Frame: 4 and 8 weeks ]measured in ng/mL
- Change of the value of insulin-like growth factor (IGF-1) [ Time Frame: 4 and 8 weeks ]measured in ng/mL
- Change of the value of epinephrine [ Time Frame: 4 and 8 weeks ]measured in pg/mL
- Change of the value of norepinephrine [ Time Frame: 4 and 8 weeks ]measured in pg/mL
- Change of the value of cortisol [ Time Frame: 4 and 8 weeks ]measured in mcg/dL
- Change in C-reactive protein [ Time Frame: 4 and 8 weeks ]measured in mg/L
- Change in blood pressure prior and after exercise [ Time Frame: 1-8 week ]measured in mmHg
- Change in heat-shock protein (HSP-72) [ Time Frame: 4 and 8 weeks ]measured in ng/mL
- Change in resting and post-exercise heart rate [ Time Frame: 4 and 8 weeks ]Measured in beats per min
- Change of from-the-questionnaire-obtained quality of life [ Time Frame: 4 and 8 weeks ]Measured in points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087292
|Contact: Tim Kambič, BSc||+386 (0)email@example.com|
|Contact: Borut Jug, PhD, MDfirstname.lastname@example.org|
|University Medical Centre||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Borut Jug, PhD, MD email@example.com|
|Contact: Tim Kambič, BSc +386(0)40830858 firstname.lastname@example.org|
|Principal Investigator: Borut Jug, PhD, MD|
|Sub-Investigator: Tim Kambič, BSc|
|Sub-Investigator: Marko Novaković, MD|
|Sub-Investigator: Katja Tomažin, PhD|
|Sub-Investigator: Vojko Strojnik, PhD|