Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 3:06 AM
Study NCT ID:
NCT03923660
Status:
UNKNOWN
Last Update Posted:
2019-04-22
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-19', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilatory adaptation', 'timeFrame': 'week 1', 'description': 'Breathing frequency/tidal volume ratio at the maximum common minute ventilation.'}], 'secondaryOutcomes': [{'measure': 'Dynamic hyperinflation', 'timeFrame': 'week 1', 'description': 'Dynamic hyperinflation will be assessed through iterative inspiratory capacity (IC) measurment during exercise. A decrease in IC \\>150 mL compared to resting levels at any time point during exercise will be considered as dynamic hyperinflation.'}, {'measure': 'Brachial muscle enrollment', 'timeFrame': 'week 1', 'description': '2.4 GHz electromyographic activity of biceps brachii recorded using surface electrod (Cometa Wave Plus wireless EMG)'}, {'measure': 'Quadriceps muscle enrollment', 'timeFrame': 'week 1', 'description': '2.4 GHz electromyographic activity of vastus lateralis recorded using surface electrod (Cometa Wave Plus wireless EMG)'}, {'measure': 'Ventilatory efficiency', 'timeFrame': 'week 1', 'description': 'Dead volume/Tidal volume ratio'}, {'measure': 'Ventilatory efficiency', 'timeFrame': 'week 1', 'description': 'Minute ventilation/Carbon dioxide production ratio'}, {'measure': 'Tolerance', 'timeFrame': 'week 1', 'description': 'Borg modified scale \\[ranging from 0 to 10\\] for dyspnoea 0 indicates no dyspnoea and 10 the maximum dyspnoea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'breathing pattern', 'exercise', 'concentric', 'eccentric'], 'conditions': ['Chronic Obstructive Pulmonary Disease Severe']}, 'descriptionModule': {'briefSummary': 'Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.\n\nHowever, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.\n\nEndurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.\n\nNevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.\n\nThe main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.', 'detailedDescription': 'Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.\n\nHowever, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.\n\nEndurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.\n\nNevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.\n\nThe main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe COPD (FEV1 \\[forced expiratory volume in 1 second\\] / FVC \\[forced vital capacity\\] \\< 70% et FEV1 \\< 50%)\n* Informed consent\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Effort oxygen therapy\n* Cardiovascular, neuromuscular or musculoskeletal disorders that can provide significant dyspnea or limit exercise\n* Legal incapacity\n* Low or no cooperation anticipated'}, 'identificationModule': {'nctId': 'NCT03923660', 'acronym': 'CONvEX', 'briefTitle': 'Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD', 'orgStudyIdInfo': {'id': 'P/2018/374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concentric-eccentric', 'description': 'Concentric-eccentric', 'interventionNames': ['Other: Incremental Concentric-eccentric exercise test']}, {'type': 'EXPERIMENTAL', 'label': 'Eccentric-concentric', 'description': 'Eccentric-concentric', 'interventionNames': ['Other: Incremental Eccentric-concentric exercise test']}], 'interventions': [{'name': 'Incremental Concentric-eccentric exercise test', 'type': 'OTHER', 'description': 'Patients will perform incremental exercise test on semi recumbent eccentric ergometer', 'armGroupLabels': ['Concentric-eccentric']}, {'name': 'Incremental Eccentric-concentric exercise test', 'type': 'OTHER', 'description': 'Patients will perform incremental exercise test on semi recumbent concentric ergometer', 'armGroupLabels': ['Eccentric-concentric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}