Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-02-17 @ 10:48 PM
Study NCT ID:
NCT00542932
Status:
COMPLETED
Last Update Posted:
2007-10-12
First Post:
2007-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Home Exercise Video Programme for Patients With 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-11', 'studyFirstSubmitDate': '2007-10-11', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental Shuttle Walk Test', 'timeFrame': 'Baseline and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Chronic Respiratory Disease Questionnaire', 'timeFrame': 'Baseline and 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Exercise', 'Home'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes in the form of pulmonary rehabilitation (PR) have been shown to improve both of these symptoms significantly. PR involves patients attending a hospital or community centre. For some patients, leaving the house is an ordeal. This study investigated the effectiveness of an exercise video programme delivered in the patients home.', 'detailedDescription': 'Pulmonary Rehabilitation (PR) has been shown to deliver cost-effective improvements in dyspnoea, exercise tolerance and health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD). PR programmes in the United Kingdom (UK) are typically delivered on an outpatient basis, either at a hospital or suitable site in the community. It is not always possible however, for patients to access outpatient programmes due to lack of local availability or adequate transport from isolated locations. Severe breathlessness may reduce activity levels to such a degree that for many leaving the house is an ordeal. A British Lung Foundation (BLF) survey reported that less than 2% of UK COPD patients had access to a rehabilitation exercise programme, despite National Institute for Health and Clinical Excellence (NICE) and British Thoracic Society (BTS) recommendations that PR be made available to all patients who are functionally limited by dyspnoea. Meeting the demand for PR remains a challenge.\n\nAccess to the benefits of PR may be broadened if effective exercise could be administered at home. Current evidence suggests that home-based rehabilitation interventions result in smaller benefits as judged by exercise tolerance and quality of life when compared to supervised programmes. The impact of home based rehabilitation may be limited by multiple factors including, lack of health care professional supervision and lack of support from fellow COPD sufferers. This lack of support may lead to poor adherence to prescribed exercise intensity and frequency in home programmes.\n\nOne-to-one supervision on an individual basis is unlikely to be feasible or cost-effective, however, use of a home exercise video could enhance adherence to prescribed exercise programmes. Video media can be an effective means of delivering exercise instruction. No published research to date has investigated the effectiveness of a home exercise video for patients with COPD. We hypothesised that an exercise programme based on video instruction at home, could improve walking ability, breathlessness and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate/severe COPD\n* Access to a video or DVD player\n\nExclusion Criteria:\n\n* Comorbid condition that precludes safe exercise\n* Previous attendance at a pulmonary rehabilitation programme'}, 'identificationModule': {'nctId': 'NCT00542932', 'briefTitle': 'The Effects of a Home Exercise Video Programme for Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'The Effects of a Home Exercise Video Programme for Patients With Chronic Obstructive Pulmonary Disease:Pilot Study', 'orgStudyIdInfo': {'id': '05/Q0703/151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'I'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Exercise', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Watched Film A (promotional film)\n\nFilm B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'John Moxham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Brighton', 'class': 'OTHER'}]}}}