Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2007-03-31
2008-04-30
Brief Summary
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The 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.
Therefore 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.
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Detailed Description
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Patients 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.
Patients 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.
Measurements 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1: comprehensive PR
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.
comprehensive PR
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.
2: UEET + PR
Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.
UEET
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Interventions
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comprehensive PR
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.
UEET
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
* clinical stability for a minimum of 4 weeks
* degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale
Exclusion Criteria
* cognitive impairment limiting participation
* previous inclusion in UEET programmes within the last 3 years
* malignancies
ALL
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Villa Pineta Hospital
OTHER
Responsible Party
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Villa Pineta Hospital
Principal Investigators
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Stefania Costi, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Modena and Reggio Emilia
Enrico M Clini, Professor
Role: STUDY_CHAIR
Villa Pineta Hospital and University of Modena and Reggio Emilia
Locations
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Villa Pineta Hospital
Pavullo nel Frignano, Modena, Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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UEET0307
Identifier Type: -
Identifier Source: org_study_id
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