Efficacy of Arm Training in COPD Patients

NCT00825032 | Completed

• 1 other identifier: UEET0307
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary disease, chronic obstructive; Upper extremity; Exercise therapy

Outcome Measures

Primary Outcomes (1)

• 6-min. ring test (6MRT)

  T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

Secondary Outcomes (4)

• ADL field test

  T0=baseline, Tend (week three)

• LCADL

  T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

• MRC

  T0=baseline, Tend (week three)

• 6MWT

  T0=baseline, Tend (week three)

Study Arms (2)

1: comprehensive PR

ACTIVE COMPARATOR

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.

Procedure: comprehensive PR

2: UEET + PR

EXPERIMENTAL

Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.

Procedure: UEET

Interventions

comprehensive PR PROCEDURE

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.

Also known as: Pulmonary Rehabilitation

1: comprehensive PR

UEET PROCEDURE

Experimental program consisting of 15 additional daily sessions of unsupported UEET.

Also known as: Upper extremity exercise training

2: UEET + PR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• muscular-skeletal abnormalities limiting the shoulder girdle functionality
• cognitive impairment limiting participation
• malignancies

Sponsors & Collaborators

• Villa Pineta Hospital: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

Villa Pineta Hospital

Pavullo nel Frignano, Modena, 41026, Italy

Location

Related Publications (3)

• 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: 19282362 BACKGROUND

• 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: 17494825 BACKGROUND

• 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.

  PMID: 19567487 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefania Costi, Dr

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Enrico M Clini, Professor

  Villa Pineta Hospital and University of Modena and Reggio Emilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: March 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: August 4, 2011

Record last verified: 2009-05

Locations

IT (1)