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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03087292
Date of registration: 15/03/2017
Prospective Registration: No
Primary sponsor: University Medical Centre Ljubljana
Public title: Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
Scientific 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
Date of first enrolment: February 27, 2017
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03087292
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Slovenia
Contacts
Name:     Borut Jug, PhD, MD
Address: 
Telephone:
Email: borut.jug@gmail.com
Affiliation: 
Name:     Tim Kambic, BSc
Address: 
Telephone: +386 (0)40830858
Email: tim.kambic@gmail.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Coronary Artery Disease
Coronary Disease
Intervention(s)
Other: Resistance training with vascular occlusion
Primary Outcome(s)
Change in maximal strength [Time Frame: 4 weeks, 8 weeks]
Secondary Outcome(s)
Change of the value of norepinephrine [Time Frame: 4 and 8 weeks]
Change of the value of blood human growth hormon (HGH) [Time Frame: 4 and 8 weeks]
Change in heat-shock protein (HSP-72) [Time Frame: 4 and 8 weeks]
Change in resting and post-exercise heart rate [Time Frame: 4 and 8 weeks]
Change in maximal voluntary contraction (MVC) [Time Frame: 4 and 8 weeks]
Change of the value of testosterone [Time Frame: 4 and 8 weeks]
Change in blood pressure prior and after exercise [Time Frame: 1-8 week]
Change in C-reactive protein [Time Frame: 4 and 8 weeks]
Change of from-the-questionnaire-obtained quality of life [Time Frame: 4 and 8 weeks]
Change of the value of insulin-like growth factor (IGF-1) [Time Frame: 4 and 8 weeks]
Change of the value of cortisol [Time Frame: 4 and 8 weeks]
Change in muscle hypertrophy (muscle thickness) [Time Frame: 4 and 8 weeks]
Change of the value of epinephrine [Time Frame: 4 and 8 weeks]
Change of the value of mechano growth factor (MGF) [Time Frame: 4 and 8 weeks]
Change of the value of myostatin [Time Frame: 4 and 8 weeks]
Changes of flow-mediated dilatation of the brachial artery [Time Frame: 4 weeks, 8 weeks]
Secondary ID(s)
UKCLRehab022017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Ljubljana, Faculty of Sport
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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