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

NCT ID: NCT03087292

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2017-06-15

Brief Summary

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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

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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.)

Conditions

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Coronary Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Resistance training with vascular occlusion

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Borut Jug

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Tim Kambič, BSc

Role: CONTACT

+386 (0)40830858

Borut Jug, PhD, MD

Role: CONTACT

Facility Contacts

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Borut Jug, PhD, MD

Role: primary

Tim Kambič, BSc

Role: backup

+386(0)40830858

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 15668354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16263889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10683360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19760431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20150565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21922259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21735386 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32496365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31244668 (View on PubMed)

Other Identifiers

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UKCLRehab022017

Identifier Type: -

Identifier Source: org_study_id

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