Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT03087292
Status:
UNKNOWN
Last Update Posted:
2017-03-27
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal strength', 'timeFrame': '4 weeks, 8 weeks', 'description': 'Determined with one repetition maximum test on leg extension machine (kg)'}], 'secondaryOutcomes': [{'measure': 'Change in maximal voluntary contraction (MVC)', 'timeFrame': '4 and 8 weeks', 'description': 'Determined with modified interpolated twitch protocol'}, {'measure': 'Changes of flow-mediated dilatation of the brachial artery', 'timeFrame': '4 weeks, 8 weeks', 'description': 'Measured with ultrasound in %'}, {'measure': 'Change in muscle hypertrophy (muscle thickness)', 'timeFrame': '4 and 8 weeks', 'description': 'Measured with ultrasound in mm'}, {'measure': 'Change of the value of blood human growth hormon (HGH)', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/mL'}, {'measure': 'Change of the value of testosterone', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/dL'}, {'measure': 'Change of the value of myostatin', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/mL'}, {'measure': 'Change of the value of mechano growth factor (MGF)', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/mL'}, {'measure': 'Change of the value of insulin-like growth factor (IGF-1)', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/mL'}, {'measure': 'Change of the value of epinephrine', 'timeFrame': '4 and 8 weeks', 'description': 'measured in pg/mL'}, {'measure': 'Change of the value of norepinephrine', 'timeFrame': '4 and 8 weeks', 'description': 'measured in pg/mL'}, {'measure': 'Change of the value of cortisol', 'timeFrame': '4 and 8 weeks', 'description': 'measured in mcg/dL'}, {'measure': 'Change in C-reactive protein', 'timeFrame': '4 and 8 weeks', 'description': 'measured in mg/L'}, {'measure': 'Change in blood pressure prior and after exercise', 'timeFrame': '1-8 week', 'description': 'measured in mmHg'}, {'measure': 'Change in heat-shock protein (HSP-72)', 'timeFrame': '4 and 8 weeks', 'description': 'measured in ng/mL'}, {'measure': 'Change in resting and post-exercise heart rate', 'timeFrame': '4 and 8 weeks', 'description': 'Measured in beats per min'}, {'measure': 'Change of from-the-questionnaire-obtained quality of life', 'timeFrame': '4 and 8 weeks', 'description': 'Measured in points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood flow restriction', 'resistance training', 'coronary heart disease'], 'conditions': ['Coronary Disease', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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.'}, {'pmid': '15668354', 'type': 'BACKGROUND', '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.'}, {'pmid': '16263889', 'type': 'BACKGROUND', '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.'}, {'pmid': '10683360', 'type': 'BACKGROUND', '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.'}, {'pmid': '19760431', 'type': 'BACKGROUND', '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.'}, {'pmid': '20150565', 'type': 'BACKGROUND', '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.'}, {'pmid': '21922259', 'type': 'BACKGROUND', '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.'}, {'pmid': '21735386', 'type': 'BACKGROUND', '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.'}, {'pmid': '32496365', 'type': 'DERIVED', '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.'}, {'pmid': '31244668', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nIn 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.\n\nOcclusive 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.\n\nTo conclude, the aim of this study is to compare the effect of low intensity resistance training with vascular occlusion vs. normal physical activity on:\n\n1. muscle hypertrophy, strength and neuromuscular parameters;\n2. vascular function;\n3. and blood parameters (anabolic and catabolic hormones, catecholamines, inflammations factors, parameters of oxidative stress etc.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years old and below 75 years old\n* coronary heart disease documented with clinical event\n* stable coronary heart disease patients\n\nExclusion Criteria:\n\n* Unstable phase of coronary heart disease\n* dysfunction of left ventricle\n* residual myocardial ischemia\n* contraindications for physical activity,\n* intellectual development disorder,\n* recent dissection of aorta\n* recent vein thrombolysis'}, 'identificationModule': {'nctId': 'NCT03087292', 'briefTitle': 'Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Effect of Low Intensity Resistance Training With Vascular Occlusion on Muscle Hypertrophy, Neuromuscular Adaptations and Selected Cardiovascular Parameters in Patients With Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'UKCLRehab022017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resistance training group', '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.', 'interventionNames': ['Other: Resistance training with vascular occlusion']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients to be randomly assigned to the control group (normal physical activity) will continue with their usual physical activity regime.'}], 'interventions': [{'name': 'Resistance training with vascular occlusion', 'type': 'OTHER', '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.', 'armGroupLabels': ['Resistance training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Borut Jug, PhD, MD', 'role': 'CONTACT', 'email': 'borut.jug@gmail.com'}, {'name': 'Tim Kambič, BSc', 'role': 'CONTACT', 'email': 'tim.kambic@gmail.com', 'phone': '+386(0)40830858'}, {'name': 'Borut Jug, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tim Kambič, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marko Novaković, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katja Tomažin, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vojko Strojnik, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Centre', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Tim Kambič, BSc', 'role': 'CONTACT', 'email': 'tim.kambic@gmail.com', 'phone': '+386 (0)40830858'}, {'name': 'Borut Jug, PhD, MD', 'role': 'CONTACT', 'email': 'borut.jug@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Borut Jug', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}