search
Back to results

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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
comprehensive PR
UEET
Sponsored by
Villa Pineta Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary disease, chronic obstructive, Upper extremity, Exercise therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Villa Pineta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1: comprehensive PR

2: UEET + PR

Arm Description

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.

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

Outcomes

Primary Outcome Measures

6-min. ring test (6MRT)

Secondary Outcome Measures

ADL field test
LCADL
MRC
6MWT

Full Information

First Posted
January 15, 2009
Last Updated
August 2, 2011
Sponsor
Villa Pineta Hospital
Collaborators
University of Modena and Reggio Emilia
search

1. Study Identification

Unique Protocol Identification Number
NCT00825032
Brief Title
Efficacy of Arm Training in COPD Patients
Acronym
UEET-COPD
Official Title
Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Villa Pineta Hospital
Collaborators
University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary disease, chronic obstructive, Upper extremity, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: comprehensive PR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2: UEET + PR
Arm Type
Experimental
Arm Description
Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.
Intervention Type
Procedure
Intervention Name(s)
comprehensive PR
Other Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
UEET
Other Intervention Name(s)
Upper extremity exercise training
Intervention Description
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Primary Outcome Measure Information:
Title
6-min. ring test (6MRT)
Time Frame
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
Secondary Outcome Measure Information:
Title
ADL field test
Time Frame
T0=baseline, Tend (week three)
Title
LCADL
Time Frame
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
Title
MRC
Time Frame
T0=baseline, Tend (week three)
Title
6MWT
Time Frame
T0=baseline, Tend (week three)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania Costi, Dr
Organizational Affiliation
University of Modena and Reggio Emilia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrico M Clini, Professor
Organizational Affiliation
Villa Pineta Hospital and University of Modena and Reggio Emilia
Official's Role
Study Chair
Facility Information:
Facility Name
Villa Pineta Hospital
City
Pavullo nel Frignano
State/Province
Modena
ZIP/Postal Code
41026
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19282362
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.
Results Reference
background
PubMed Identifier
17494825
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.
Results Reference
background
PubMed Identifier
19567487
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.
Results Reference
derived

Learn more about this trial

Efficacy of Arm Training in COPD Patients

We'll reach out to this number within 24 hrs