Efficacy of Arm Training in COPD Patients

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: comprehensive PR
* Procedure: UEET


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: comprehensive PR<br>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<br>* 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.<br>* Other names: Pulmonary Rehabilitation;|
| Experimental: 2: UEET + PR<br>Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients. | Procedure: UEET<br>* Experimental program consisting of 15 additional daily sessions of unsupported UEET.<br>* Other names: Upper extremity exercise training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-min. ring test (6MRT) |  | T0=baseline, Tend (week three) , T6months (six months after the completion of the training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADL field test |  | T0=baseline, Tend (week three) | 
| LCADL |  | T0=baseline, Tend (week three) , T6months (six months after the completion of the training) | 
| MRC |  | T0=baseline, Tend (week three) | 
| 6MWT |  | T0=baseline, Tend (week three) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary disease, chronic obstructive, Upper extremity, Exercise therapy