Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 4:08 PM
Study NCT ID:
NCT05734534
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2022-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of BFR Interventions in Healthy Individuals and Individuals With COPD
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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)', 'description': 'Maximal voluntary isometric contraction of m. quadriceps femoris'}], 'secondaryOutcomes': [{'measure': 'Lean mass', 'timeFrame': 'Change assessed from before to after the 6 week intervention', 'description': 'Lean mass assessed by dual X-ray absorptiometry (DXA)'}, {'measure': 'Maximal oxygen consumption', 'timeFrame': 'Change assessed from before to after the 6 week intervention', 'description': 'VO2max during incremental exercise'}, {'measure': 'Skeletal muscle mitochondrial respiration', 'timeFrame': 'Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)', 'description': 'High resolution respirometry'}, {'measure': 'Fiber cross-sectional area', 'timeFrame': 'Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)', 'description': 'Immunohistochemistry to determine fiber cross-sectional area'}, {'measure': 'Myonuclei', 'timeFrame': 'Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)', 'description': 'Immunohistochemistry to determine number of myonuclei'}, {'measure': 'Functional exercise capacity', 'timeFrame': 'Change assessed from before to after the 6 week intervention (only in individuals with COPD)', 'description': 'Number of repetitions achieved during a 1-minute sit-to-stand test'}, {'measure': 'Satellite cells', 'timeFrame': 'Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)', 'description': 'Immunohistochemistry to determine number of satellite cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BFR', 'COPD', 'Exercise'], 'conditions': ['Healthy', 'COPD']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the effect of different blood flow restriction (BFR) interventions on muscle function and adaptations both in healthy well-trained individuals and individuals diagnosed with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for participants with COPD group are:\n\n* Diagnosis with COPD\n\nExclusion criteria participants in the COPD group are\n\n* Having experienced an acute exacerbation of COPD within the last 6 weeks (Study A)\n* Taking part in pulmonary rehabilitation within the last 3 months (Study A)\n* Presenting with a history of thromboembolic event in the lower limbs.\n\nInclusion criteria for healthy participants are:\n\n* Age between 18 and 40 years.\n* Maximal oxygen uptake (VO2max) of \\>55 ml O2/kg/min for men and \\>50 ml O2/kg/min for women\n* BMI of \\<26 and normal ECG and blood pressure.\n\nExclusion criteria for healthy participants are:\n\n* Smoking\n* chronic disease,\n* Use of prescription medication\n* Pain due to current or previous musculoskeletal injury\n* Resistance training more than once per week in the 12 months leading up to the intervention.'}, 'identificationModule': {'nctId': 'NCT05734534', 'briefTitle': 'Effects of BFR Interventions in Healthy Individuals and Individuals With COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effects of BFR Interventions on Muscle Function and Adaptations in Healthy Individuals and Individuals With COPD', 'orgStudyIdInfo': {'id': 'BFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFR-ST and BFR-HIT', 'description': 'Participants will be allocated to a BFR intervention including resistance training and high-intensity intervals performed on a bicycle ergometer, both performed with BFR.', 'interventionNames': ['Other: BFR during training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HL-ST and HIT', 'description': 'Participants will be allocated to heavy load resistance training and high-intensity intervals performed on a bicycle ergometer, both performed without BFR', 'interventionNames': ['Other: BFR during training']}, {'type': 'EXPERIMENTAL', 'label': 'BFR-P', 'description': 'Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will be allocated to application of BFR twice daily throughout their hospitalization. Participants are resting in a supine position throughout the application of BFR.', 'interventionNames': ['Other: BFR during rest']}, {'type': 'EXPERIMENTAL', 'label': 'BFR-NMES', 'description': 'Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will be allocated to application of BFR with neuromuscular electrical stimulation (BFR-NMES) twice daily throughout their hospitalization. Participants are resting in a supine position throughout the application of BFR-NMES.', 'interventionNames': ['Other: BFR during rest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will allocated to usual care, consisting of daily physiotherapy sessions.', 'interventionNames': ['Other: BFR during rest']}], 'interventions': [{'name': 'BFR during training', 'type': 'OTHER', 'description': 'Healthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT', 'armGroupLabels': ['BFR-ST and BFR-HIT', 'HL-ST and HIT']}, {'name': 'BFR during rest', 'type': 'OTHER', 'description': 'Participants experiencing acute exacerbation of their COPD requiring hospitalization will be randomized to either BFR-P, BFR-NMES or the control group throughout their hospitalization.', 'armGroupLabels': ['BFR-NMES', 'BFR-P', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Hostrup', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4535321595'}], 'facility': 'August Krogh Building', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Hostrup', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4535321595'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}