Efficacy of Arm Training in COPD Patients (UEET-COPD)

• ClinicalTrials.gov Identifier: NCT00825032
• Recruitment Status: Completed
• First Posted: January 19, 2009
• Last Update Posted: August 4, 2011
• Sponsor: Villa Pineta Hospital
• Collaborator: University of Modena and Reggio Emilia
• Information provided by: Villa Pineta Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Procedure: comprehensive PR; Procedure: UEET	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
• Study Start Date: March 2007
• Actual Primary Completion Date: October 2007
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: 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.; Other Name: Pulmonary Rehabilitation
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.	Procedure: UEET; Experimental program consisting of 15 additional daily sessions of unsupported UEET.; Other Name: Upper extremity exercise training

Outcome Measures

Primary Outcome Measures :

1. 6-min. ring test (6MRT) [ Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training) ]

Secondary Outcome Measures :

1. ADL field test [ Time Frame: T0=baseline, Tend (week three) ]
2. LCADL [ Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training) ]
3. MRC [ Time Frame: T0=baseline, Tend (week three) ]
4. 6MWT [ Time Frame: T0=baseline, Tend (week three) ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Villa Pineta Hospital

Pavullo nel Frignano, Modena, Italy, 41026

Sponsors and Collaborators

Villa Pineta Hospital

University of Modena and Reggio Emilia

Investigators

• Principal Investigator: Stefania Costi, Dr; University of Modena and Reggio Emilia
• Study Chair: Enrico M Clini, Professor; Villa Pineta Hospital and University of Modena and Reggio Emilia

More Information

Publications:

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. Review.

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Enrico M. Clini, Villa Pineta Hospital
• ClinicalTrials.gov Identifier: NCT00825032
• Other Study ID Numbers: UEET0307
• First Posted: January 19, 2009
• Last Update Posted: August 4, 2011
• Last Verified: May 2009

Keywords provided by Villa Pineta Hospital:

Pulmonary disease, chronic obstructive; Upper extremity; Exercise therapy

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive