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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03087292
• Other study ID #: UKCLRehab022017
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2017
• Last updated: March 22, 2017
• Start date: February 27, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: March 2017
• Source: University Medical Centre Ljubljana
• Contact: Tim Kambic, BSc
• Phone: +386 (0)40830858
• Email: tim.kambic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana, Faculty of Sport

Country where clinical trial is conducted

Slovenia, 

References & Publications (8)

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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2016;1:CD001800. — View 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. — View 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. Erratum in: Circulation. 2005 Apr 5;111(13):1717. — View Citation

Loenneke JP, Wilson JM, Marín 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. — View 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.

Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Piña 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal strength	Determined with one repetition maximum test on leg extension machine (kg)	4 weeks, 8 weeks
Secondary	Change in maximal voluntary contraction (MVC)	Determined with modified interpolated twitch protocol	4 and 8 weeks
Secondary	Changes of flow-mediated dilatation of the brachial artery	Measured with ultrasound in %	4 weeks, 8 weeks
Secondary	Change in muscle hypertrophy (muscle thickness)	Measured with ultrasound in mm	4 and 8 weeks
Secondary	Change of the value of blood human growth hormon (HGH)	measured in ng/mL	4 and 8 weeks
Secondary	Change of the value of testosterone	measured in ng/dL	4 and 8 weeks
Secondary	Change of the value of myostatin	measured in ng/mL	4 and 8 weeks
Secondary	Change of the value of mechano growth factor (MGF)	measured in ng/mL	4 and 8 weeks
Secondary	Change of the value of insulin-like growth factor (IGF-1)	measured in ng/mL	4 and 8 weeks
Secondary	Change of the value of epinephrine	measured in pg/mL	4 and 8 weeks
Secondary	Change of the value of norepinephrine	measured in pg/mL	4 and 8 weeks
Secondary	Change of the value of cortisol	measured in mcg/dL	4 and 8 weeks
Secondary	Change in C-reactive protein	measured in mg/L	4 and 8 weeks
Secondary	Change in blood pressure prior and after exercise	measured in mmHg	1-8 week
Secondary	Change in heat-shock protein (HSP-72)	measured in ng/mL	4 and 8 weeks
Secondary	Change in resting and post-exercise heart rate	Measured in beats per min	4 and 8 weeks
Secondary	Change of from-the-questionnaire-obtained quality of life	Measured in points	4 and 8 weeks