Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-29 @ 7:58 PM
Study NCT ID:
NCT01583595
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2012-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-01', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analyze associations between self-efficacy for walking, gait speed, physical activity level and perceptions of symptoms in patient with chronic lung disease (COPD and Pulmonary Fibrosis)', 'timeFrame': 'Day of enrollment.', 'description': 'Correlation , regression models and mediation analysis (self efficacy and physical activity) will be performed.'}], 'secondaryOutcomes': [{'measure': 'Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor.', 'timeFrame': '1 week', 'description': 'Measure 4-meter gait speed during standardized 6 mintute walk test and compare to armband activity monitor results to determine predictive ability, if any, on PAL in people with chronic lung disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Lung Disease', 'Exercise', 'Self-efficacy'], 'conditions': ['Chronic Lung Disease', 'Self-efficacy']}, 'descriptionModule': {'briefSummary': 'Most patients with chronic lung disease underestimate their actual walking ability due to low confidence. To better understand the relationships between lung function, self-efficacy for walking (confidence in ability to walk a defined distance), actual walking ability for the same distance gait speed and physical activity level-PAL- (total energy expenditure/resting metabolic rate).\n\nQuality of life, self efficacy for activity questionnaires, physical activity level measurement, 4-meter gait speed and 6-minute walk distance will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with chronic lung disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 40 years and older\n* Diagnosis of any chronic lung disease as evidenced by pulmonary function testing completed within the prior 12 months\n* Able to walk independently and successfully complete the 6-minute walk assessment\n\nExclusion Criteria:\n\n* Unable to walk without assistance or complete the 6-minute walk assessment\n* Patients unable to comprehend and accurately respond to the study questionnaires either by written or spoken communication\n* Patients diagnosed with or treated for a lower respiratory tract infection or COPD exacerbation within the prior 30 days'}, 'identificationModule': {'nctId': 'NCT01583595', 'briefTitle': 'Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Determining the Relationships Between Self-efficacy for Walking Ability, Gate Speed and Physical Activity in Patients With Chronic Lung Disease', 'orgStudyIdInfo': {'id': '11-008157'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Roberto P Benzo, M.D., MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Pulmonary and Critical Care Medicine', 'investigatorFullName': 'Roberto P. Benzo', 'investigatorAffiliation': 'Mayo Clinic'}}}}