Efficacy of Arm Training in COPD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

— UEET-COPD  

Official title:

Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825032
• Other study ID #: UEET0307
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: August 2, 2011
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2009
• Source: Villa Pineta Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Italy	Villa Pineta Hospital	Pavullo nel Frignano	Modena

Sponsors (2)

Lead Sponsor	Collaborator
Villa Pineta Hospital	University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-min. ring test (6MRT)		T0=baseline, Tend (week three) , T6months (six months after the completion of the training)	No
Secondary	ADL field test		T0=baseline, Tend (week three)	No
Secondary	LCADL		T0=baseline, Tend (week three) , T6months (six months after the completion of the training)	No
Secondary	MRC		T0=baseline, Tend (week three)	No
Secondary	6MWT		T0=baseline, Tend (week three)	No