Viewing Study NCT03087292


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Study NCT ID: NCT03087292
Status: UNKNOWN
Last Update Posted: 2017-03-27
First Post: 2017-03-15
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
Sponsor: University Medical Centre Ljubljana
Organization:

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2017-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: