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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Modena
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Pavullo nel Frignano, Modena, Italia, 41026
- Villa Pineta Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
Otros nombres:
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Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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6-min. ring test (6MRT)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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ADL field test
Periodo de tiempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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LCADL
Periodo de tiempo: 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
Periodo de tiempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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6MWT
Periodo de tiempo: T0=baseline, Tend (week three)
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T0=baseline, Tend (week three)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stefania Costi, Dr, University of Modena and Reggio Emilia
- Silla de estudio: Enrico M Clini, Professor, Villa Pineta Hospital and University of Modena and Reggio Emilia
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UEET0307
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