search
Back to results

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

Primary Purpose

Coronary Disease, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Resistance training with vascular occlusion
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring blood flow restriction, resistance training, coronary heart disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Resistance training group

Control group

Arm Description

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.

Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.

Outcomes

Primary Outcome Measures

Change in maximal strength
Determined with one repetition maximum test on leg extension machine (kg)

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2017
Last Updated
March 22, 2017
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana
search

1. Study Identification

Unique Protocol Identification Number
NCT03087292
Brief Title
Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Anticipated)
Study Completion Date
June 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana

4. Oversight

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

5. Study Description

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: muscle hypertrophy, strength and neuromuscular parameters; vascular function; and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease
Keywords
blood flow restriction, resistance training, coronary heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.
Intervention Type
Other
Intervention Name(s)
Resistance training with vascular occlusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in maximal strength
Description
Determined with one repetition maximum test on leg extension machine (kg)
Time Frame
4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Change in maximal voluntary contraction (MVC)
Description
Determined with modified interpolated twitch protocol
Time Frame
4 and 8 weeks
Title
Changes of flow-mediated dilatation of the brachial artery
Description
Measured with ultrasound in %
Time Frame
4 weeks, 8 weeks
Title
Change in muscle hypertrophy (muscle thickness)
Description
Measured with ultrasound in mm
Time Frame
4 and 8 weeks
Title
Change of the value of blood human growth hormon (HGH)
Description
measured in ng/mL
Time Frame
4 and 8 weeks
Title
Change of the value of testosterone
Description
measured in ng/dL
Time Frame
4 and 8 weeks
Title
Change of the value of myostatin
Description
measured in ng/mL
Time Frame
4 and 8 weeks
Title
Change of the value of mechano growth factor (MGF)
Description
measured in ng/mL
Time Frame
4 and 8 weeks
Title
Change of the value of insulin-like growth factor (IGF-1)
Description
measured in ng/mL
Time Frame
4 and 8 weeks
Title
Change of the value of epinephrine
Description
measured in pg/mL
Time Frame
4 and 8 weeks
Title
Change of the value of norepinephrine
Description
measured in pg/mL
Time Frame
4 and 8 weeks
Title
Change of the value of cortisol
Description
measured in mcg/dL
Time Frame
4 and 8 weeks
Title
Change in C-reactive protein
Description
measured in mg/L
Time Frame
4 and 8 weeks
Title
Change in blood pressure prior and after exercise
Description
measured in mmHg
Time Frame
1-8 week
Title
Change in heat-shock protein (HSP-72)
Description
measured in ng/mL
Time Frame
4 and 8 weeks
Title
Change in resting and post-exercise heart rate
Description
Measured in beats per min
Time Frame
4 and 8 weeks
Title
Change of from-the-questionnaire-obtained quality of life
Description
Measured in points
Time Frame
4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Kambič, BSc
Phone
+386 (0)40830858
Email
tim.kambic@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Borut Jug, PhD, MD
Email
borut.jug@gmail.com
Facility Information:
Facility Name
University Medical Centre
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borut Jug, PhD, MD
Email
borut.jug@gmail.com
First Name & Middle Initial & Last Name & Degree
Tim Kambič, BSc
Phone
+386(0)40830858
Email
tim.kambic@gmail.com
First Name & Middle Initial & Last Name & Degree
Borut Jug, PhD, MD
First Name & Middle Initial & Last Name & Degree
Tim Kambič, BSc
First Name & Middle Initial & Last Name & Degree
Marko Novaković, MD
First Name & Middle Initial & Last Name & Degree
Katja Tomažin, PhD
First Name & Middle Initial & Last Name & Degree
Vojko Strojnik, PhD

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
15668354
Citation
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. doi: 10.1161/01.CIR.0000151788.08740.5C. Erratum In: Circulation. 2005 Apr 5;111(13):1717.
Results Reference
background
PubMed Identifier
16263889
Citation
Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
Results Reference
background
PubMed Identifier
10683360
Citation
Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.
Results Reference
background
PubMed Identifier
19760431
Citation
Karabulut M, Abe T, Sato Y, Bemben MG. The effects of low-intensity resistance training with vascular restriction on leg muscle strength in older men. Eur J Appl Physiol. 2010 Jan;108(1):147-55. doi: 10.1007/s00421-009-1204-5. Epub 2009 Sep 18.
Results Reference
background
PubMed Identifier
20150565
Citation
Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
Results Reference
background
PubMed Identifier
21922259
Citation
Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
Results Reference
background
PubMed Identifier
21735386
Citation
Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
Results Reference
background
PubMed Identifier
32496365
Citation
Kambic T, Novakovic M, Tomazin K, Strojnik V, Bozic-Mijovski M, Jug B. Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):507-516. doi: 10.1097/JCN.0000000000000699.
Results Reference
derived
PubMed Identifier
31244668
Citation
Kambic T, Novakovic M, Tomazin K, Strojnik V, Jug B. Blood Flow Restriction Resistance Exercise Improves Muscle Strength and Hemodynamics, but Not Vascular Function in Coronary Artery Disease Patients: A Pilot Randomized Controlled Trial. Front Physiol. 2019 Jun 12;10:656. doi: 10.3389/fphys.2019.00656. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs