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

This study has been completed.
Sponsor:
Collaborator:
University of Modena and Reggio Emilia
Information provided by:
Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT00825032
First received: January 15, 2009
Last updated: August 2, 2011
Last verified: May 2009
History of Changes
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
 Procedure: comprehensive PR
Procedure: UEET

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • 6-min. ring test (6MRT) [ Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADL field test [ Time Frame: T0=baseline, Tend (week three) ] [ Designated as safety issue: No ]
  • LCADL [ Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training) ] [ Designated as safety issue: No ]
  • MRC [ Time Frame: T0=baseline, Tend (week three) ] [ Designated as safety issue: No ]
  • 6MWT [ Time Frame: T0=baseline, Tend (week three) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825032

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:

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

Responsible Party: Prof. Enrico M. Clini, Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT00825032     History of Changes
Other Study ID Numbers: UEET0307
Study First Received: January 15, 2009
Last Updated: August 2, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Villa Pineta Hospital:
Pulmonary disease, chronic obstructive
Upper extremity
Exercise therapy

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013