title: Efficacy of a physical exercise training programme COPD in primary care: study protocol of a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The Netherlands National Trial Register NTR1471.
authors.affiliation: Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. annemieke.fastenau@maastrichtuniversity.nl.
authors.forename: Annemieke
authors.initials: A
authors.lastname: Fastenau
authors.forename: Jean W M
authors.initials: JW
authors.lastname: Muris
authors.forename: Rob A
authors.initials: RA
authors.lastname: de Bie
authors.forename: Erik J M
authors.initials: EJ
authors.lastname: Hendriks
authors.forename: Guus M
authors.initials: GM
authors.lastname: Asijee
authors.forename: Emmylou
authors.initials: E
authors.lastname: Beekman
authors.forename: Rik
authors.initials: R
authors.lastname: Gosselink
authors.forename: Onno C P
authors.initials: OC
authors.lastname: van Schayck
mesh_terms: D001945:Breathing Exercises; D004417:Dyspnea / Q000209:etiology; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength; D026741:Physical Therapy Modalities; D011320:Primary Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000503:physiopathology / Q000534:rehabilitation / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D055070:Resistance Training; D012720:Severity of Illness Index
references.citation: Eur Respir J. 2009 Feb;33(2):262-72
references.pmid: 19010994
references.citation: Br J Sports Med. 2005 May;39(5):294-7; discussion 294-7
references.pmid: 15849294
references.citation: Am J Respir Crit Care Med. 2005 May 1;171(9):972-7
references.pmid: 15665324
references.citation: Thorax. 2003 Jun;58(6):515-8
references.pmid: 12775865
references.citation: Prim Care Respir J. 2010 Jun;19(2):124-30
references.pmid: 20126968
references.citation: Prim Care Respir J. 2009 Sep;18(3):171-6
references.pmid: 19142557
references.citation: Eur Respir J. 2010 Jul;36(1):81-8
references.pmid: 19897554
references.citation: Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7
references.pmid: 9817683
references.citation: J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):52-9
references.pmid: 20724933
references.citation: J Cardiopulm Rehabil. 2005 Jul-Aug;25(4):207-9
references.pmid: 16056066
references.citation: Med Sci Sports Exerc. 2007 Aug;39(8):1423-34
references.pmid: 17762377
references.citation: J Cardiopulm Rehabil. 2001 Jan-Feb;21(1):10-7
references.pmid: 11271652
references.citation: Qual Life Res. 2007 Feb;16(1):131-42
references.pmid: 17033901
references.citation: Chron Respir Dis. 2012 Feb;9(1):17-26
references.pmid: 22194629
references.citation: BMC Fam Pract. 2013 Feb 11;14:21
references.pmid: 23399113
references.citation: Respir Med. 2010 Jul;104(7):1005-11
references.pmid: 20167463
references.citation: Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65
references.pmid: 22878278
references.citation: Eur Respir J. 1997 Jan;10(1):104-13
references.pmid: 9032501
references.citation: Thorax. 1999 Jul;54(7):581-6
references.pmid: 10377201
references.citation: Am J Med. 2000 Aug 15;109(3):207-12
references.pmid: 10974183
references.citation: Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38
references.pmid: 15778487
references.citation: Arch Phys Med Rehabil. 1985 Feb;66(2):69-74
references.pmid: 3970660
references.citation: Control Clin Trials. 1990 Apr;11(2):116-28
references.pmid: 2161310
references.citation: Respir Med. 2013 Feb;107(2):242-8
references.pmid: 23085213
references.citation: Control Clin Trials. 1989 Dec;10(4):407-15
references.pmid: 2691207
references.citation: Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7
references.pmid: 12091180
references.citation: Med Sci Sports Exerc. 2011 Jul;43(7):1334-59
references.pmid: 21694556
references.citation: Thorax. 2006 Sep;61(9):772-8
references.pmid: 16738033
references.citation: Phys Ther. 1996 Mar;76(3):248-59
references.pmid: 8602410
references.citation: Thorax. 2001 Dec;56(12):954-9
references.pmid: 11713359
references.citation: Health Qual Life Outcomes. 2003 Apr 28;1:13
references.pmid: 12773199
references.citation: Respir Med. 2008 Jan;102(1):162-71
references.pmid: 17881207
references.citation: Int J Chron Obstruct Pulmon Dis. 2008;3(3):443-51
references.pmid: 18990973
references.citation: Eur Respir J. 2010 Jan;35(1):79-87
references.pmid: 19574331
references.citation: BMJ. 2005 Oct 22;331(7522):961-3
references.pmid: 16239696
references.citation: Med Sci Sports Exerc. 1994 Sep;26(9):1078-81
references.pmid: 7808239
references.citation: Eura Medicophys. 2007 Dec;43(4):475-85
references.pmid: 18084170
references.citation: Cochrane Database Syst Rev. 2013 Oct 10;(10):CD009437
references.pmid: 24108523
references.citation: Respir Med. 2012 Dec;106(12):1671-9
references.pmid: 23063203
references.citation: Thorax. 2010 Jan;65(1):7-13
references.pmid: 19703824
references.citation: Chest. 2000 Feb;117(2 Suppl):5S-9S
references.pmid: 10673466
references.citation: Respir Res. 2006 Apr 07;7:62
references.pmid: 16603063
references.citation: Chest. 1991 Apr;99(4):805-8
references.pmid: 2009778
references.citation: Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):2021-31
references.pmid: 8520771
references.citation: Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51
references.pmid: 18048807
references.citation: Thorax. 1987 Oct;42(10):773-8
references.pmid: 3321537
references.citation: Eur Respir J. 2006 Apr;27(4):788-94
references.pmid: 16481381
references.citation: Respir Med. 2011 Mar;105(3):418-26
references.pmid: 20951018
references.citation: Patient Educ Couns. 2004 Mar;52(3):237-41
references.pmid: 14998592
references.citation: Circulation. 2012 Oct 30;126(18):2261-74
references.pmid: 22952317
references.citation: Patient Educ Couns. 1997 Jul;31(3):191-203
references.pmid: 9277242
references.citation: Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413
references.pmid: 16760357
references.citation: Chest. 2008 Aug;134(2):273-280
references.pmid: 18403667