Efficacy of Arm Training in COPD Patients (UEET-COPD)
Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Modena
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Pavullo nel Frignano, Modena, Italia, 41026
- Villa Pineta Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- diagnosis of COPD
- 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:
- muscular-skeletal abnormalities limiting the shoulder girdle functionality
- cognitive impairment limiting participation
- previous inclusion in UEET programmes within the last 3 years
- malignancies
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
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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.
Altri nomi:
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Sperimentale: 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.
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Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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6-min. ring test (6MRT)
Lasso di tempo: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
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T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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ADL field test
Lasso di tempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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LCADL
Lasso di tempo: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
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T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
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MRC
Lasso di tempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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6MWT
Lasso di tempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Stefania Costi, Dr, University of Modena and Reggio Emilia
- Cattedra di studio: Enrico M Clini, Professor, Villa Pineta Hospital and University of Modena and Reggio Emilia
Pubblicazioni e link utili
Pubblicazioni generali
- 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, 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.
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UEET0307
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