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Open Access Study protocol

Efficacy of a physical exercise training programme COPD in primary care: study protocol of a randomized controlled trial

Annemieke Fastenau1*, Jean WM Muris1, Rob A de Bie23, Erik JM Hendriks4, Guus M Asijee15, Emmylou Beekman23, Rik Gosselink6 and Onno CP van Schayck1

Author Affiliations

1 Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands

2 Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands

3 Centre for Evidence Based Physiotherapy, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands

4 Physical therapy practice, Fysiotherapie Maasstaete, Druten, The Netherlands

5 Boehringer Ingelheim, Alkmaar, The Netherlands

6 KU Leuven, Faculty of Kinesiology and Rehabilitation Sciences, Tervuursevest 101, box 1500, 3001 Leuven, Belgium

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BMC Public Health 2014, 14:788  doi:10.1186/1471-2458-14-788

Published: 3 August 2014

Abstract

Background

Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD.

Methods/design

In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients’ perceived effectiveness. Follow-up measurement will take place at 6 months after baseline.

Discussion

This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme.

Trial registration

The Netherlands National Trial Register NTR1471.

Keywords:
Chronic obstructive pulmonary disease; Exercise training; Physical activity; Primary care; Randomized controlled trial