Efficacy of Arm Training in COPD Patients (UEET-COPD)
Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Modena
-
Pavullo nel Frignano, Modena, Italy, 41026
- Villa Pineta Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
|
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.
|
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
6-min. ring test (6MRT)
Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
|
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ADL field test
Time Frame: T0=baseline, Tend (week three)
|
T0=baseline, Tend (week three)
|
|
LCADL
Time Frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
|
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
|
|
MRC
Time Frame: T0=baseline, Tend (week three)
|
T0=baseline, Tend (week three)
|
|
6MWT
Time Frame: T0=baseline, Tend (week three)
|
T0=baseline, Tend (week three)
|
Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UEET0307
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