Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT00825032
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Arm Training in COPD Patients
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2009-01-16', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-min. ring test (6MRT)', 'timeFrame': 'T0=baseline, Tend (week three) , T6months (six months after the completion of the training)'}], 'secondaryOutcomes': [{'measure': 'ADL field test', 'timeFrame': 'T0=baseline, Tend (week three)'}, {'measure': 'LCADL', 'timeFrame': 'T0=baseline, Tend (week three) , T6months (six months after the completion of the training)'}, {'measure': 'MRC', 'timeFrame': 'T0=baseline, Tend (week three)'}, {'measure': '6MWT', 'timeFrame': 'T0=baseline, Tend (week three)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary disease, chronic obstructive', 'Upper extremity', 'Exercise therapy'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '19282362', 'type': 'BACKGROUND', 'citation': "Costi S, Di Bari M, Pillastrini P, D'Amico R, Crisafulli E, Arletti C, Fabbri LM, Clini EM. Short-term efficacy of upper-extremity exercise training in patients with chronic airway obstruction: a systematic review. Phys Ther. 2009 May;89(5):443-55. doi: 10.2522/ptj.20070368. Epub 2009 Mar 12."}, {'pmid': '17494825', 'type': 'BACKGROUND', 'citation': 'Ries AL, Bauldoff GS, Carlin BW, Casaburi R, Emery CF, Mahler DA, Make B, Rochester CL, Zuwallack R, Herrerias C. Pulmonary Rehabilitation: Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. Chest. 2007 May;131(5 Suppl):4S-42S. doi: 10.1378/chest.06-2418.'}, {'pmid': '19567487', 'type': 'DERIVED', 'citation': 'Costi S, Crisafulli E, Degli Antoni F, Beneventi C, Fabbri LM, Clini EM. Effects of unsupported upper extremity exercise training in patients with COPD: a randomized clinical trial. Chest. 2009 Aug;136(2):387-395. doi: 10.1378/chest.09-0165. Epub 2009 Jun 30.'}]}, 'descriptionModule': {'briefSummary': "Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).\n\nThe theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.\n\nTherefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.", 'detailedDescription': "We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.\n\nPatients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.\n\nPatients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.\n\nMeasurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of COPD\n* a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification\n* clinical stability for a minimum of 4 weeks\n* degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale\n\nExclusion Criteria:\n\n* muscular-skeletal abnormalities limiting the shoulder girdle functionality\n* cognitive impairment limiting participation\n* previous inclusion in UEET programmes within the last 3 years\n* malignancies'}, 'identificationModule': {'nctId': 'NCT00825032', 'acronym': 'UEET-COPD', 'briefTitle': 'Efficacy of Arm Training in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Villa Pineta Hospital'}, 'officialTitle': 'Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UEET0307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: comprehensive PR', 'description': 'Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.', 'interventionNames': ['Procedure: comprehensive PR']}, {'type': 'EXPERIMENTAL', 'label': '2: UEET + PR', 'description': 'Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.', 'interventionNames': ['Procedure: UEET']}], 'interventions': [{'name': 'comprehensive PR', 'type': 'PROCEDURE', 'otherNames': ['Pulmonary Rehabilitation'], 'description': 'Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.', 'armGroupLabels': ['1: comprehensive PR']}, {'name': 'UEET', 'type': 'PROCEDURE', 'otherNames': ['Upper extremity exercise training'], 'description': 'Experimental program consisting of 15 additional daily sessions of unsupported UEET.', 'armGroupLabels': ['2: UEET + PR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41026', 'city': 'Pavullo nel Frignano', 'state': 'Modena', 'country': 'Italy', 'facility': 'Villa Pineta Hospital', 'geoPoint': {'lat': 44.33352, 'lon': 10.83544}}], 'overallOfficials': [{'name': 'Stefania Costi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}, {'name': 'Enrico M Clini, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Villa Pineta Hospital and University of Modena and Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Pineta Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Enrico M. Clini', 'oldOrganization': 'Villa Pineta Hospital'}}}}