Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-21 @ 4:01 PM
Study NCT ID:
NCT02261350
Status:
TERMINATED
Last Update Posted:
2015-11-02
First Post:
2014-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-hospitalisation Nutritional Support and Gait Speed in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D011656', 'term': 'Pulmonary Emphysema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung 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': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in four-metre gait speed (m/s) following nutritional support', 'timeFrame': 'Change from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in weight (kg) following nutritional support', 'timeFrame': 'Change from baseline to 12 weeks'}, {'measure': 'Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support', 'timeFrame': 'Change from baseline to 12 weeks'}, {'measure': 'Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support', 'timeFrame': 'Change from baseline to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Respiratory Tract Diseases', 'Lung Diseases, Obstructive', 'Bronchitis, Chronic', 'Pulmonary Emphysema']}, 'descriptionModule': {'briefSummary': 'To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to consent\n* Patients at moderate or severe risk of malnutrition\n* Adults over the age of 40\n* Hospitalised with an AECOPD\n\nExclusion Criteria:\n\n* Receiving long term parental or enteral nutrition\n* Inability to swallow or difficulty liquids\n* Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance\n* Co-existing active cancer, progressive neurological condition or active GI disorder.\n* Receiving palliative care with expectation of death within 3 months\n* Cognitive dysfunction or unable to consent"}, 'identificationModule': {'nctId': 'NCT02261350', 'briefTitle': 'Post-hospitalisation Nutritional Support and Gait Speed in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Royal Brompton & Harefield NHS Foundation Trust'}, 'officialTitle': 'The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD', 'orgStudyIdInfo': {'id': '2013LF004H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food Fortification', 'description': 'Food Fortification', 'interventionNames': ['Dietary Supplement: Food fortification']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Nutritional Supplements', 'description': 'Oral Nutritional Supplements - Fortisip Compact', 'interventionNames': ['Dietary Supplement: Oral Nutritional Supplements']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Food fortification', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Food Fortification']}, {'name': 'Oral Nutritional Supplements', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fortisip Compact, Nutricia Clinical'], 'armGroupLabels': ['Oral Nutritional Supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'UB8 3NN', 'city': 'Uxbridge', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'The Hillingdon Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}], 'overallOfficials': [{'name': 'William Man, PhD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton & Harefield NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'The Hillingdon Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}