Clinical trial NCT00825032: Efficacy of Arm Training in COPD Patients
Official title: Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary disease, chronic obstructive
Upper extremity
Exercise therapy
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
First posted: 2009-01-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: 6-min. ring test (6MRT)
timeFrame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
Secondary outcomes:
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)
Other outcomes:
Locations:
city: Pavullo nel Frignano
country: Italy
facility: Villa Pineta Hospital
state: Modena
Study officials:
affiliation: University of Modena and Reggio Emilia
name: Stefania Costi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Villa Pineta Hospital and University of Modena and Reggio Emilia
name: Enrico M Clini, Professor
role: STUDY_CHAIR
References:
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.
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.
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.