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Completed

NCT Number: NCT00825032

Efficacy of Arm Training in COPD Patients

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Pineta Hospital

Pavullo nel Frignano, Modena, 41026, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comprehensive PR

Procedure

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: Pulmonary Rehabilitation

UEET

Procedure

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

Other names: Upper extremity exercise training

Primary outcomes

  1. 6-min. ring test (6MRT)

    Time frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

Secondary outcomes

  1. ADL field test

    Time frame: T0=baseline, Tend (week three)

  2. LCADL

    Time frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

  3. MRC

    Time frame: T0=baseline, Tend (week three)

  4. 6MWT

    Time frame: T0=baseline, Tend (week three)

Sponsors and collaborators

Lead sponsor

Villa Pineta Hospital

Other

Collaborators

  • University of Modena and Reggio Emilia

Registry information

Official study title

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

Acronym: UEET-COPD

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jan 19, 2009
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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