Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-11 @ 6:15 PM
Study NCT ID:
NCT01539434
Status:
UNKNOWN
Last Update Posted:
2017-05-19
First Post:
2012-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-minute walking distance', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Change in six-minute walking distance'}], 'secondaryOutcomes': [{'measure': 'Physical activity level', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Number of steps, energy expenditure, time in different positions'}, {'measure': 'Short Form 36', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Measures health related quality of life'}, {'measure': 'Chronic Respiratory Disease Questionnaire', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Measures health related quality of life'}, {'measure': 'Hospital anxiety and depression scale', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Measures anxiety and depression'}, {'measure': 'Grippit', 'timeFrame': 'Change from baseline and 6 months and up to 24 months', 'description': 'Hand muscle strength'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Behavioral intervention', 'Physical capacity', 'Physical activity'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease and the number of patients is increasing. Persons with COPD have a low physical capacity and a low physical activity level. The risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. Rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. Unfortunately improvements decrease if patients do not maintain their physical activity level.\n\nTo change physical activity behaviour in is challenging. Different methods as Social Cognitive Theory, SCT and the Transtheoretical model, TTM have been suggested as theoretical framework. According to SCT, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring.\n\nTo use motivational interviewing (MI) improves the success of a behaviour change.\n\nPatients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations.\n\nThereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. The telephone calls will be in accordance with MI and discuss goal-setting, out-come expectancy, and self-monitoring.\n\nPatients will be tested after 6,12,and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.\n* Diagnose of COPD\n\nExclusion criteria:\n\n* Understand the Swedish language\n* Be able to be physically active'}, 'identificationModule': {'nctId': 'NCT01539434', 'acronym': 'COPD', 'briefTitle': 'Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Behavioral Medicine Intervention to Maintain Physical Capacity and Level of Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'UOU-2012-MEKW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioural intervention', 'description': 'Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.', 'interventionNames': ['Behavioral: Behavioural intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care group', 'description': 'Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.', 'interventionNames': ['Behavioral: Usual care group']}], 'interventions': [{'name': 'Behavioural intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Physical capacity', 'Physical activity'], 'description': 'Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.', 'armGroupLabels': ['Behavioural intervention']}, {'name': 'Usual care group', 'type': 'BEHAVIORAL', 'otherNames': ['Physical capacity', 'Physical activity'], 'description': 'Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.', 'armGroupLabels': ['Usual care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75124', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Margareta Emtner, PhD', 'role': 'CONTACT', 'email': 'margareta.emtner@neuro.uu.se', 'phone': '+46184714761'}, {'name': 'Christer Janson, Professor', 'role': 'CONTACT', 'email': 'christer.janson@medsci.uu.se', 'phone': '+46704250441'}, {'name': 'Margareta Emtner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Johanna Holmbäck, PT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Margareta Emtner, PhD', 'role': 'CONTACT', 'email': 'margareta.emtner@neuro.uu.se', 'phone': '+46184714761'}], 'overallOfficials': [{'name': 'Margareta Emtner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}, {'name': 'Karin Wadell, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Umeå University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Umeå University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}