Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-07 @ 4:27 PM
Study NCT ID:
NCT02802618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-06
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2016-05-27', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved health related quality of life', 'timeFrame': 'Change from Baseline health related quality of life at 10 weeks', 'description': 'COPD Assessment Test'}], 'secondaryOutcomes': [{'measure': 'Improved health related quality of life', 'timeFrame': 'Change from Baseline health related quality of life at 10 weeks', 'description': 'S:t George´s Respiratory Questionnaire'}, {'measure': 'Improved health related quality of life', 'timeFrame': 'Change from Baseline health related quality of life at 2 and 10 weeks', 'description': 'Leicester Cough Questionnaire'}, {'measure': 'Improved exercise self efficacy', 'timeFrame': 'Change from Baseline exercise self efficacy at 10 weeks', 'description': 'SCI Exercise Self Efficacy Scale (SCI=Spinal Cord Injury)'}, {'measure': 'Improved physical performance', 'timeFrame': 'Change from Baseline physical performance at 10 weeks', 'description': 'JAMAR Hydraulic Hand Dynamometer'}, {'measure': 'Improved physical performance', 'timeFrame': 'Change from Baseline physical performance at 10 weeks', 'description': '6 minute walk test'}, {'measure': 'Attendance to rehabilitation programme', 'timeFrame': '10 weeks', 'description': 'Attendance record'}, {'measure': 'Improved knowledge of content in rehabilitation programme', 'timeFrame': 'Change from Baseline knowledge of content in rehabilitation programme at 6 months', 'description': 'Questionaire'}, {'measure': 'Compliance to treatment', 'timeFrame': '6 months', 'description': 'Single question about compliance to treatment'}, {'measure': 'Compliance to physical activity', 'timeFrame': '6 months', 'description': 'Single question about compliance to physical activity'}, {'measure': 'Visits to hospital, primary care', 'timeFrame': '6 months', 'description': 'Single question about number of visits to hospital and primary care'}, {'measure': 'Motivation with rehabilitation programme', 'timeFrame': '6 months', 'description': 'Visual analog scale, focus group interview'}, {'measure': 'Stimulation with the of rehabilitation programme', 'timeFrame': '6 months', 'description': 'Visual analog scale, focus group interview'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Validity', 'Reliability', 'Rehabilitation', 'Translation', 'Education'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '39830146', 'type': 'RESULT', 'citation': 'Sonnerfors P, Nordlin AK, Nykvist M, Thunstrom U, Einarsson U. Interactive 3D visualisation technique used in pulmonary rehabilitation in chronic obstructive pulmonary disease: A randomised controlled study evaluating quality of life, compliance and use of health care. Digit Health. 2025 Jan 17;11:20552076241308940. doi: 10.1177/20552076241308940. eCollection 2025 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': "A new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL\n\nThe purpose of this study was therefore to develop a pulmonary educational program in interactive 3D visualization technology and to evaluate differences between education with 3D technique or conventional technique in patient with COPD.\n\nFurthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability.", 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is one of the major health scourges. In 2002 COPD was the fifth leading cause of death and estimates show that COPD becomes in 2030 the third leading cause of death worldwide. The dominant cause of COPD is tobacco smoking. COPD now affects men and women almost equally. The most common symptoms of COPD are breathlessness, excessive sputum production, and a chronic cough which causes decrease in health related quality of life (HRQL). Dyspnea and movement limitations are also common symptoms in patients with COPD and this often leads to reduced levels of physical activity, physical capacity and HRQL. The Leicester Cough Questionnaire (LCQ) is a valid evaluation tool for HRQL in patients with chronic cough. Currently no specific cough questionnaire exists in Swedish.\n\nPulmonary rehabilitation including education and exercise training improves health. The Physiotherapy department has conducted rehabilitation programs for patients with COPD since 1995. The COPD-program has several times been updated according to existing evidence.\n\nEducation in anatomy, physiology, physical therapy and self-training is a big part of the physical therapist's workday. The education imparts complex knowledge. It is demanding to mediate this as education is expected to raise the patient's desire to understand, create opportunities to understand and leave a lasting impression. In effective learning repetition, own search for information, stimulation, emotional impact and experience are important factors. Information technology is developing rapidly and patient's use of this technology is increasing. It is therefore essential that education is adapted to new requirements. Interactive 3 dimensional (3D) visualization techniques can be used to represent the human body. Interactive 3D technique used in patient education has not yet been studied.\n\nA new education material with 3D technique was developed, by integrating 3D technology in an existing evidence-based pulmonary educational program, to enable an increased personalized education within a group setting. The investigators believe that this educational model will lead to increased adherence to treatment, and suggested lifestyle changes, which in turn improves patients' HRQL\n\nIn the current study it will be investigated whether och not there are differences between pulmonary educational program in interactive 3D visualization technology and in conventional technique in patients with COPD.\n\nFurthermore the LCQ will be translated and culturally adapted into Swedish and tested for validity and reliability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic obstructive pulmonary disease (COPD)\n* Stadium II-IV of COPD\n* Must be able to comprehend the Swedish language\n\nExclusion Criteria:\n\n* Not diagnosed with COPD\n* Does not understand written and verbal Swedish'}, 'identificationModule': {'nctId': 'NCT02802618', 'briefTitle': 'Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '2013/1276-31/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive 3D visualization technique', 'description': 'The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with 3D technique.\n\nPatients randomized into education by 3D technique.', 'interventionNames': ['Other: Interactive 3D visualization technique']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional technique', 'description': 'The pulmonary rehabilitation consists of exercise training during 10 weeks and a theoretic part presented with conventional technique. Patients randomized into education by conventional technique.'}], 'interventions': [{'name': 'Interactive 3D visualization technique', 'type': 'OTHER', 'description': 'The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.', 'armGroupLabels': ['Interactive 3D visualization technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of physiotherapy, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Ulrika Einarsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Heart and Lung Association', 'class': 'OTHER'}, {'name': 'Landstingens Ömsesidiga Försäkringsbolag (Löf)', 'class': 'UNKNOWN'}, {'name': 'Flemingsberg Science', 'class': 'UNKNOWN'}, {'name': 'The Mats Kleberg Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Ulrika Einarsson', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}