Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-30 @ 11:10 PM
Study NCT ID:
NCT04162392
Status:
UNKNOWN
Last Update Posted:
2019-11-14
First Post:
2019-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Barriers in AECOPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life: EQ-5D', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up', 'description': 'European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health). The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).'}, {'measure': 'Functional capacity', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up', 'description': 'The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.'}, {'measure': 'Barriers to Being Active Quiz', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up', 'description': 'The Barriers to Being Active Quiz is a 21-item scale that provides a measure of 7 self-reported barriers to being physically active.This instrument uses a 4-point Likert scale for individuals to identify if they would say or think any of the statements would be true for them, with 0 being very unlikely to 3 being very likely. Per instrument instructions, each barrier has 3 items that are summed for scoring, with a range of 0 to 9 for each.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a good option to improve physical activity barriers in acute exacerbated COPD patients during the hospitalization period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were COPD patients hospitalized due to acute exacerbation\n\nExclusion Criteria:\n\n* Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.'}, 'identificationModule': {'nctId': 'NCT04162392', 'briefTitle': 'Physical Activity Barriers in AECOPD', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Physical Activity Barriers in Acute Exacerbated COPD', 'orgStudyIdInfo': {'id': 'DF0084UG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Other: shared decision making']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'shared decision making', 'type': 'OTHER', 'description': 'Patients can choose the intervention that they want. There are different physiotherapy interventions were the patients have to do physical activity during the hospital stay. The physiotherapist explains the advantages and disadvantages of each treatment before they choose.', 'armGroupLabels': ['Experimental group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'Patients receive a physiotherapy intervention but they do not have the opportunity to choose the treatment', 'armGroupLabels': ['Control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}