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

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ClinicalTrials.gov Identifier: NCT03087292
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
University of Ljubljana, Faculty of Sport
Information provided by (Responsible Party):
Borut Jug, 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).

Condition or disease Intervention/treatment Phase
Coronary Disease Coronary Artery Disease Other: Resistance training with vascular occlusion Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in maximal strength [ Time Frame: 4 weeks, 8 weeks ]
    Determined with one repetition maximum test on leg extension machine (kg)


Secondary Outcome Measures :
  1. Change in maximal voluntary contraction (MVC) [ Time Frame: 4 and 8 weeks ]
    Determined with modified interpolated twitch protocol

  2. Changes of flow-mediated dilatation of the brachial artery [ Time Frame: 4 weeks, 8 weeks ]
    Measured with ultrasound in %

  3. Change in muscle hypertrophy (muscle thickness) [ Time Frame: 4 and 8 weeks ]
    Measured with ultrasound in mm

  4. Change of the value of blood human growth hormon (HGH) [ Time Frame: 4 and 8 weeks ]
    measured in ng/mL

  5. Change of the value of testosterone [ Time Frame: 4 and 8 weeks ]
    measured in ng/dL

  6. Change of the value of myostatin [ Time Frame: 4 and 8 weeks ]
    measured in ng/mL

  7. Change of the value of mechano growth factor (MGF) [ Time Frame: 4 and 8 weeks ]
    measured in ng/mL

  8. Change of the value of insulin-like growth factor (IGF-1) [ Time Frame: 4 and 8 weeks ]
    measured in ng/mL

  9. Change of the value of epinephrine [ Time Frame: 4 and 8 weeks ]
    measured in pg/mL

  10. Change of the value of norepinephrine [ Time Frame: 4 and 8 weeks ]
    measured in pg/mL

  11. Change of the value of cortisol [ Time Frame: 4 and 8 weeks ]
    measured in mcg/dL

  12. Change in C-reactive protein [ Time Frame: 4 and 8 weeks ]
    measured in mg/L

  13. Change in blood pressure prior and after exercise [ Time Frame: 1-8 week ]
    measured in mmHg

  14. Change in heat-shock protein (HSP-72) [ Time Frame: 4 and 8 weeks ]
    measured in ng/mL

  15. Change in resting and post-exercise heart rate [ Time Frame: 4 and 8 weeks ]
    Measured in beats per min

  16. Change of from-the-questionnaire-obtained quality of life [ Time Frame: 4 and 8 weeks ]
    Measured in points



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Tim Kambič, BSc +386 (0)40830858 tim.kambic@gmail.com
Contact: Borut Jug, PhD, MD borut.jug@gmail.com

Locations
Slovenia
University Medical Centre Recruiting
Ljubljana, Slovenia, 1000
Contact: Borut Jug, PhD, MD       borut.jug@gmail.com   
Contact: Tim Kambič, BSc    +386(0)40830858    tim.kambic@gmail.com   
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         
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana, Faculty of Sport

Publications:
Nakajima, T., et al. Use and safety of KAATSU training: results of a national survey. Int J KAATSU Train Res; 2(1): 5-13, 2006.
Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. Erratum in: Circulation. 2005 Apr 5;111(13):1717.

Responsible Party: Borut Jug, Assistant Professor, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03087292     History of Changes
Other Study ID Numbers: UKCLRehab022017
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Borut Jug, University Medical Centre Ljubljana:
blood flow restriction
resistance training
coronary heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases