Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
Study NCT ID:
NCT04521959
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2020-08-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '40 COPD patients will be randomised divided into two equal groups according to age, gender and disease severity.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two randomized controlled intervention groups will be formed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1/FVC rate', 'timeFrame': 'eight weeks', 'description': 'respiratory function test'}, {'measure': 'creatine kinase', 'timeFrame': 'eight weeks', 'description': 'muscle breakdown marker'}, {'measure': 'c reactive protein', 'timeFrame': 'eight weeks', 'description': 'thrombus formation risk marker'}, {'measure': 'd-dimer', 'timeFrame': 'eight weeks', 'description': 'venous thromboembolism marker'}, {'measure': 'total antioxidant status', 'timeFrame': 'eight weeks', 'description': 'oxidative stress marker'}, {'measure': 'total oxidant status', 'timeFrame': 'eight weeks', 'description': 'oxidative stress marker'}, {'measure': 'interleukin 6', 'timeFrame': 'eight weeks', 'description': 'inflammation marker'}, {'measure': 'oxygen saturation', 'timeFrame': 'three times a week', 'description': 'blood gas test'}, {'measure': 'heart rate', 'timeFrame': 'three times a week', 'description': 'for exercise dose determination'}, {'measure': 'six minute walk test', 'timeFrame': 'eight weeks', 'description': 'strength evaluation'}, {'measure': "ST george's respiratory questionnaire", 'timeFrame': 'eight weeks', 'description': "used to evaluate the effects of respiratory disease's symptoms and illness"}, {'measure': 'quadriceps muscle diameter', 'timeFrame': 'eight weeks', 'description': 'Measurement of change in muscle volume'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD, blood flow restriction, exercise'], 'conditions': ['Copd']}, 'referencesModule': {'references': [{'pmid': '31156448', 'type': 'BACKGROUND', 'citation': 'Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.'}, {'pmid': '31684769', 'type': 'BACKGROUND', 'citation': 'Nolan CM, Rochester CL. Exercise Training Modalities for People with Chronic Obstructive Pulmonary Disease. COPD. 2019 Dec;16(5-6):378-389. doi: 10.1080/15412555.2019.1637834. Epub 2019 Nov 4.'}, {'pmid': '25430600', 'type': 'BACKGROUND', 'citation': 'Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.'}, {'pmid': '21385216', 'type': 'BACKGROUND', 'citation': 'Kacin A, Strazar K. Frequent low-load ischemic resistance exercise to failure enhances muscle oxygen delivery and endurance capacity. Scand J Med Sci Sports. 2011 Dec;21(6):e231-41. doi: 10.1111/j.1600-0838.2010.01260.x. Epub 2011 Mar 8.'}, {'pmid': '25338316', 'type': 'BACKGROUND', 'citation': 'Loenneke JP, Allen KM, Mouser JG, Thiebaud RS, Kim D, Abe T, Bemben MG. Blood flow restriction in the upper and lower limbs is predicted by limb circumference and systolic blood pressure. Eur J Appl Physiol. 2015 Feb;115(2):397-405. doi: 10.1007/s00421-014-3030-7. Epub 2014 Oct 22.'}, {'pmid': '23446173', 'type': 'BACKGROUND', 'citation': 'Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31828a1ffa.'}, {'pmid': '21436993', 'type': 'BACKGROUND', 'citation': 'Berzosa C, Cebrian I, Fuentes-Broto L, Gomez-Trullen E, Piedrafita E, Martinez-Ballarin E, Lopez-Pingarron L, Reiter RJ, Garcia JJ. Acute exercise increases plasma total antioxidant status and antioxidant enzyme activities in untrained men. J Biomed Biotechnol. 2011;2011:540458. doi: 10.1155/2011/540458. Epub 2011 Mar 9.'}, {'pmid': '30687436', 'type': 'BACKGROUND', 'citation': 'Wilk M, Krzysztofik M, Gepfert M, Poprzecki S, Golas A, Maszczyk A. Technical and Training Related Aspects of Resistance Training Using Blood Flow Restriction in Competitive Sport - A Review. J Hum Kinet. 2018 Dec 31;65:249-260. doi: 10.2478/hukin-2018-0101. eCollection 2018 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic obstructive pulmonary disease (COPD) classified by a pulmonologist in accordance with the GOLD criteria will be randomly divided into 2 groups.\n\nThe first group (n = 20) was accompanied by blood flow restriction (CAC), 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, progressive resistance exercise (PRE) and after 5 minutes of rest by cycling. Progressive aerobic exercise (AE) (BFR PRE + AE group) in the target heart rate range of 50-80% intensity will be applied to the second group (n = 20), PRE and AE (PRE + AE group) performed at the same intensity and duration without BFR.', 'detailedDescription': 'Determination of application groups: Patients with chronic obstructive pulmonary disease (COPD) classified by a pulmonologist in accordance with the GOLD criteria will be randomly divided into 2 groups and application groups will be determined.\n\nApplications to be made:\n\nThe first group (n = 20) accompanied by BFR; Progressive resistance training (RT) 3 times a week, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, and cycling after 5 minutes rest, progressive aerobic training (AT)in the target heart rate range of 40-80% intensity will be applied.\n\nTo the second group (n = 20) without BFR; 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds of rest interval, and after 5 minutes of rest will be applied in the target heart rate range of 40-80%, which is done by cycling.\n\nCalculation of 1RM: Epley formula will be used in the calculation. According to this; 1 RM = (1 + .0333 x number of repetitions) x weight removed.\n\nProgress in resistance exercise; According to the modified borg scale (MBS), the amount of the lifted weight calculated on the basis of the increase in the 1RM value measured in every three consecutive sessions will be provided by increasing the amount of weight, on the condition that it remains between 4-6 intensity.\n\nThis too; It will be calculated from the formula "Target heart rate = (Maximal heart rate-resting heart rate) x% desired intensity ratio + resting heart rate".\n\nThe target occlusion amount in the lower extremity will be calculated by calculating 45% of the complete occlusion rates reported by Michael et al. The proximal border of the thigh cuffs in the BFR group will be tied at the level of the gluteal lines on both sides.\n\nExercise tolerance and dyspnea condition; Measurement properties in COPD will be evaluated using a modified Borg scale (MBS), which has well-defined characteristics. Individuals will use bronchodilators approved by their physician before each trial and continue drug therapy throughout the study.\n\nThe target aerobic exercise intensity will be reached in the last minute of the first five-minute warm-up period by maintaining a 4-6 feeling of dyspnea in the MBS, by increasing pedal resistance and speed. The intensity increase will be increased by 5% for each subsequent session and the target heart rate will be limited to 80%. In case of extreme shortness of breath, the intensity of exercise will be reduced down to the resting heart rate.\n\nIn case of oxygen desaturation (85%) during interventions, the intervention will be suspended until the next session.\n\nAerobic exercise study protocol: warm-up at 50 RPM speed and lowest pedal resistance for the first 4 minutes, reaching the target exercise intensity range in the next 1 min, aerobic training at the target heart rate range and appropriate MBS for the next 20 minutes, the last 5 minutes It will be applied in the form of cooling. The duration will be reduced in case of extreme shortness of breath, fatigue and muscle pain due to increased exercise volume. The distance, calories, and maximum speed values measured during the first, 9 and 24 sessions will be recorded.\n\nBefore the study and at the end of the 8th week, oxidative stress markers (plasma protein carbonyl concentration, lipid hydroperoxides, total antioxidant capacity (TAK)), muscle damage status (creatine phosphokinase, myoglobin), anti-inflammatory response (interleukin 6 (IL-6), risk of venous thromboembolism and thrombus formation (D-dimer, thrombin-antithrombin 3 component (TAT), c-reactive protein (CRP), fibrinogen), body mass index, respiratory function tests (FEV1, FVC), oxygen saturation and heart rate ( pulse oximetry), six-minute walking test, and quality of life (SF-36) will be evaluated at least 6 hours prior to taking medication.\n\nThe change in the quadriceps muscle mass will be examined by a radiologist who is not involved in the study, by measuring the transverse and anteroposterior lengths of the relevant muscle using Toshiba aplio 300 brand ultrasound device.\n\nStatistical evaluation of results: Paired t-test, repeated measurement analysis of variables (RMANOVA), Kolmogorov-Smirnov test, post hoc contrast analysis, bonferroni correction will be used in the statistical analysis of intervention results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Since COPD affects male gender more, the number of male patients participating in the intervention is higher than female patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with mild to severe COPD according to GOLD criteria in the age range of 40-78\n* No drug change for at least 30 days\n* Not participating in a structured activity program for at least six months\n* Have the ability to cooperate.\n\nExclusion Criteria:\n\n* Presence of any pathology that limits physical activity performance\n* Presence of severe or unstable heart disease\n* Presence of peripheral artery disease\n* Being in an exacerbation period of the disease\n* Presence of another active disease (rheumatic, oncological, traumatic etc.)\n* Any neurological or orthopedic disease that prevents exercise'}, 'identificationModule': {'nctId': 'NCT04521959', 'acronym': 'COPD', 'briefTitle': 'The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'The Effect Of Blood Flow Restrıcted Resistive And Aerobic Exercises in Chronic Obstructive Pulmonary Patients', 'orgStudyIdInfo': {'id': 'istanbul medipol university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blood Flow Restricted Aerobic and Resistance Exercise Group', 'description': 'kan akımı kısıtlanarak.direnç ve bisikletle aerobik egzersiz uygulanacak', 'interventionNames': ['Procedure: Blood flow restricted and normal aerobic exercise and resistance exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal aerobik ve direnç egzersiz grubu', 'description': 'Normal şartlarda aerobik ve direnç egzersizi uygulanacak', 'interventionNames': ['Procedure: Blood flow restricted and normal aerobic exercise and resistance exercise']}], 'interventions': [{'name': 'Blood flow restricted and normal aerobic exercise and resistance exercise', 'type': 'PROCEDURE', 'description': 'Interventions of the same duration and intensity will be applied to two groups.', 'armGroupLabels': ['Blood Flow Restricted Aerobic and Resistance Exercise Group', 'Normal aerobik ve direnç egzersiz grubu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78600', 'city': 'Karabük', 'state': 'Karabük Province', 'country': 'Turkey (Türkiye)', 'facility': 'Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Ahmet Gunes', 'investigatorAffiliation': 'Medipol University'}}}}