Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-12 @ 11:40 PM
Study NCT ID:
NCT01739751
Status:
UNKNOWN
Last Update Posted:
2012-12-04
First Post:
2012-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Enhancement Using Pedometers in 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect in average steps walked daily', 'timeFrame': '3 months', 'description': 'Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation'}], 'secondaryOutcomes': [{'measure': 'six minute walking distance', 'timeFrame': '3 months', 'description': 'Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation'}, {'measure': 'score in the Saint George Respiratory Questionnaire', 'timeFrame': '3 months', 'description': 'Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation'}, {'measure': 'Score of the COPD Assessment Test (CAT)', 'timeFrame': '3 months', 'description': 'Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Physical activity', 'Pedometers', 'steps', 'non pharmacological treatment', 'rehabilitation', 'exercise'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '18029834', 'type': 'BACKGROUND', 'citation': 'Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.'}]}, 'descriptionModule': {'briefSummary': 'Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.', 'detailedDescription': 'Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD diagnosis according to GOLD guidelines\n* Pack year Index equal or more than 10\n* smoking suspended \\> 2 months\n* older than 40 years old,\n\nExclusion Criteria:\n\n* any chronic condition that does not allow walking\n* participation in a rehabilitation program\n* Acute exacerbation in the last two months'}, 'identificationModule': {'nctId': 'NCT01739751', 'briefTitle': 'Physical Activity Enhancement Using Pedometers in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'SA10i20022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients without feedback of a pedometers, followed for 3 months'}, {'type': 'EXPERIMENTAL', 'label': 'Pedometers', 'description': 'With a program of physical activity enhancement using pedometers as a feedback', 'interventionNames': ['Device: pedometers']}], 'interventions': [{'name': 'pedometers', 'type': 'DEVICE', 'otherNames': ['PD 724'], 'description': 'portable device that estimate the number of steps walked daily', 'armGroupLabels': ['Pedometers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380456', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Clínico Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Laura Mendoza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comisión Nacional de Investigación Científica y Tecnológica', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Laura Mendoza', 'investigatorAffiliation': 'University of Chile'}}}}