Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT02613351
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2015-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'slope of the relationship between self-reported breathing and leg heaviness using Borg scale', 'timeFrame': '1 week', 'description': 'Borg scale ratings of breathing and leg heaviness will be measured during stepwise incremental speed exercise tests. The relationship between leg and breathing heaviness with increasing demand (speed) is quantified by the slope of the relationship between self-reported breathing and leg heaviness under each condition of customary walking and scooting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise Tolerance', 'Lung Diseases, Obstructive'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD: FEV1 \\< 80 % and FEV1/FVC \\< 0.7;\n* Able to communicate in English\n* Clinically stable\n\nExclusion Criteria:\n\n* predominant co-morbidities or treatments that might influence the results of exercise testing'}, 'identificationModule': {'nctId': 'NCT02613351', 'acronym': 'MAPLE', 'briefTitle': 'Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD', 'organization': {'class': 'OTHER', 'fullName': 'West Park Healthcare Centre'}, 'officialTitle': 'Leg Muscle Activity and Sensation During Upright Partitioned Exercise Compared to Walking: Propulsion of a 3-wheeled Scooter by Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'WPHC-RG-1Lscoot20151201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'scooting', 'description': 'incremental test to establish the relationship between leg and breathing heaviness with increasing demand (speed) during scooting', 'interventionNames': ['Device: scooting']}], 'interventions': [{'name': 'scooting', 'type': 'DEVICE', 'description': 'three-wheeled scooter (Monark 662, Monark Exercise AB Sweden) comprised of a single front wheel that provides steering and two rear wheels that create a wide base of support.', 'armGroupLabels': ['scooting']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6M 2J5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Westpark Health Care Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Roger S Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Park Healthcare Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Park Healthcare Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Directory Respiratory Medicine', 'investigatorFullName': 'Roger Goldstein', 'investigatorAffiliation': 'West Park Healthcare Centre'}}}}