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

NCT03087292 | Unknown

• 1 other identifier: UKCLRehab022017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Disease; Coronary Artery Disease

Keywords

blood flow restriction; resistance training; coronary heart disease

Outcome Measures

Primary Outcomes (1)

• Change in maximal strength

  Determined with one repetition maximum test on leg extension machine (kg)

  4 weeks, 8 weeks

Secondary Outcomes (16)

• Change in maximal voluntary contraction (MVC)

  4 and 8 weeks

• Changes of flow-mediated dilatation of the brachial artery

  4 weeks, 8 weeks

• Change in muscle hypertrophy (muscle thickness)

  4 and 8 weeks

• Change of the value of blood human growth hormon (HGH)

  4 and 8 weeks

• Change of the value of testosterone

  4 and 8 weeks

Study Arms (2)

Resistance training group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Resistance training with vascular occlusion OTHER

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.

Resistance training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• above 18 years old and below 75 years old
• coronary heart disease documented with clinical event
• stable coronary heart disease patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana: collaborator

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  PMID: 15668354 BACKGROUND

• 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.

  PMID: 16263889 BACKGROUND

• 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.

  PMID: 10683360 BACKGROUND

• 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.

  PMID: 19760431 BACKGROUND

• 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.

  PMID: 20150565 BACKGROUND

• 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.

  PMID: 21922259 BACKGROUND

• 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.

  PMID: 21735386 BACKGROUND

• 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.

  PMID: 32496365 DERIVED

• 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.

  PMID: 31244668 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tim Kambič, BSc

CONTACT

+386 (0)40830858; tim.kambic@gmail.com

Borut Jug, PhD, MD

CONTACT

borut.jug@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 22, 2017
• Study Start: February 27, 2017
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

SL (1)