title: Exploring the effect of space and place on response to exercise therapy for knee and hip pain--a protocol for a double-blind randomised controlled clinical trial: the CONEX trial.
abstract: BACKGROUND
  Context effects are described as effects of a given treatment, not directly caused by the treatment itself, but rather caused by the context in which treatment is delivered. Exercise is a recommended core treatment in clinical guidelines for musculoskeletal disorders. Although moderately effective overall, variation is seen in size of response to exercise across randomised controlled trial (RCT) studies. Part of this variation may be related to the fact that exercise interventions are performed in different physical environments, which may affect participants differently. The study aims to investigate the effect of exercising in a contextually enhanced physical environment for 8 weeks in people with knee or hip pain.
  
  
  METHODS
  The study is a double-blind RCT. Eligible participants are 35 years or older with persisting knee and/or hip pain for 3 months. Participants are randomised to one of three groups: (1) exercise in a contextually enhanced environment, (2) exercise in a standard environment and (3) waiting list. The contextually enhanced environment is located in a newly built facility, has large windows providing abundant daylight and overlooks a recreational park. The standard environment is in a basement, has artificial lighting and is marked by years of use; that is, resembling many clinical environments. The primary outcome is the participant's global perceived effect rated on a seven-point Likert scale after 8 weeks exercise. Patient-reported and objective secondary outcomes are included.
  
  
  BACKGROUND
  The Regional Scientific Ethical Committee for Southern Denmark has approved the study. Study findings will be disseminated in peer-reviewed publications and presented at national and international conferences.
  
  
  BACKGROUND
  NCT02043613.
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
authors.forename: Louise Fleng
authors.identifier: http://orcid.org/0000-0001-8436-1046
authors.initials: LF
authors.lastname: Sandal
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
authors.forename: Jonas Bloch
authors.initials: JB
authors.lastname: Thorlund
authors.affiliation: Chalmers University of Technology, Gothenburg, Sweden.
authors.forename: Roger S
authors.initials: RS
authors.lastname: Ulrich
authors.affiliation: University of Exeter, Medical School, Exeter, UK.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Dieppe
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
authors.forename: Ewa M
authors.initials: EM
authors.lastname: Roos
mesh_terms: D000328:Adult; D015308:Anaerobic Threshold; D018771:Arthralgia / Q000628:therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods* / Q000523:psychology*; D020446:Fitness Centers; D006272:Health Facility Environment; D006621:Hip Joint; D006801:Humans; D007719:Knee Joint; D053580:Muscle Strength; D010465:Perception
keywords: SPORTS MEDICINE
references.citation: J Intern Med. 2004 Aug;256(2):91-100
references.pmid: 15257721
references.citation: J Electromyogr Kinesiol. 2002 Jun;12(3):205-12
references.pmid: 12086815
references.citation: Clin Geriatr Med. 2010 Aug;26(3):419-31
references.pmid: 20699163
references.citation: Psychol Rev. 1977 Mar;84(2):191-215
references.pmid: 847061
references.citation: J Orthop Sports Phys Ther. 2001 Nov;31(11):632-44
references.pmid: 11720296
references.citation: Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52
references.pmid: 23680877
references.citation: J Am Med Assoc. 1955 Dec 24;159(17):1602-6
references.pmid: 13271123
references.citation: Eur J Clin Pharmacol. 1996;50(5):345-8
references.pmid: 8839653
references.citation: J Clin Epidemiol. 2006 Apr;59(4):331-5
references.pmid: 16549251
references.citation: Ann Rheum Dis. 2014 Jun;73(6):1130-7
references.pmid: 23661494
references.citation: Scand J Rheumatol. 2003;32(1):46-51
references.pmid: 12635946
references.citation: Cochrane Database Syst Rev. 2003;(1):CD003974
references.pmid: 12535498
references.citation: Lancet. 2001 Mar 10;357(9258):757-62
references.pmid: 11253970
references.citation: J Man Manip Ther. 2009;17(3):163-70
references.pmid: 20046623
references.citation: Patient Educ Couns. 2010 Sep;80(3):293-9
references.pmid: 20638817
references.citation: Physiother Res Int. 2008 Sep;13(3):141-52
references.pmid: 18697226
references.citation: BMC Musculoskelet Disord. 2003 May 30;4:10
references.pmid: 12777182
references.citation: HERD. 2012 Winter;5(2):46-60
references.pmid: 23154902
references.citation: Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S473-85
references.pmid: 22588769
references.citation: J Orthop Sports Phys Ther. 2011 May;41(5):319-27
references.pmid: 21335930
references.citation: Scand J Med Sci Sports. 2009 Apr;19(2):156-65
references.pmid: 18397193
references.citation: BMC Musculoskelet Disord. 2010;11:126
references.pmid: 20565735
references.citation: Pain. 2008 Feb;134(3):241-4
references.pmid: 18178010
references.citation: Arthritis Care Res (Hoboken). 2010 Sep;62(9):1244-51
references.pmid: 20853469
references.citation: J Clin Nurs. 2002 Jul;11(4):462-9
references.pmid: 12100642
references.citation: Chest. 2003 Mar;123(3):941-8
references.pmid: 12628899
references.citation: Arthritis Rheum. 2005 Nov;52(11):3507-14
references.pmid: 16258919
references.citation: BMC Musculoskelet Disord. 2012;13:104
references.pmid: 22703639
references.citation: Dtsch Arztebl Int. 2009 Nov;106(46):751-5
references.pmid: 20019863
references.citation: Pain. 2005 Mar;114(1-2):303-9
references.pmid: 15733657
references.citation: Ann Fam Med. 2004 Nov-Dec;2(6):595-608
references.pmid: 15576546
references.citation: Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62
references.pmid: 22944525
references.citation: Ann Intern Med. 2002 Mar 19;136(6):471-6
references.pmid: 11900500
references.citation: Science. 1984 Apr 27;224(4647):420-1
references.pmid: 6143402
references.citation: Occup Med (Lond). 2011 Sep;61(6):434-6
references.pmid: 21505089
references.citation: Ann Intern Med. 2002 Jun 4;136(11):817-25
references.pmid: 12044130
references.citation: Scand J Med Sci Sports. 1998 Jun;8(3):154-9
references.pmid: 9659676
references.citation: Med Care. 1992 Jun;30(6):473-83
references.pmid: 1593914
references.citation: HERD. 2011 Spring;4(3):14-43
references.pmid: 21866502
references.citation: BMC Health Serv Res. 2007;7:198
references.pmid: 18053239
references.citation: Scand J Rehabil Med. 1992;24(2):91-7
references.pmid: 1604267
references.citation: Scand J Med Sci Sports. 2007 Apr;17(2):120-7
references.pmid: 17394472
references.citation: BMJ. 2008 May 3;336(7651):999-1003
references.pmid: 18390493
references.citation: Med Care. 1993 Mar;31(3):247-63
references.pmid: 8450681
references.citation: Health Qual Life Outcomes. 2003;1:17
references.pmid: 12801417
references.citation: Arthritis Rheum. 1989 Jan;32(1):37-44
references.pmid: 2912463
references.citation: Perspect Biol Med. 2006 Spring;49(2):178-98
references.pmid: 16702703
references.citation: J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96
references.pmid: 9699158
references.citation: Patient Educ Couns. 2010 Sep;80(3):307-14
references.pmid: 20691557
references.citation: Med Care. 1994 Jan;32(1):40-66
references.pmid: 8277801
references.citation: N Engl J Med. 2001 May 24;344(21):1594-602
references.pmid: 11372012
references.citation: Patient Educ Couns. 2011 Sep;84(3):413-9
references.pmid: 21621366
references.citation: BMJ. 2005 May 21;330(7501):1202-5
references.pmid: 15905259
references.citation: BMC Musculoskelet Disord. 2010;11:265
references.pmid: 21080945
references.citation: Surv Ophthalmol. 1999 Jul-Aug;44(1):31-44
references.pmid: 10466586
references.citation: Dan Med J. 2012 Dec;59(12):A4554
references.pmid: 23290290
references.citation: Med Clin North Am. 2003 Sep;87(5):1115-45
references.pmid: 14621334
references.citation: Behav Res Ther. 1981;19(2):157-67
references.pmid: 7271692
references.citation: Scand J Med Sci Sports. 1998 Dec;8(6):439-48
references.pmid: 9863983
references.citation: J Rheumatol. 2002 Aug;29(8):1737-45
references.pmid: 12180738
references.citation: Arthritis Care Res (Hoboken). 2010 Sep;62(9):1229-36
references.pmid: 20506122
references.citation: BMC Fam Pract. 2013;14:65
references.pmid: 23697479
references.citation: Br Med J (Clin Res Ed). 1987 May 9;294(6581):1200-2
references.pmid: 3109581
references.citation: J R Soc Med. 2008 May;101(5):222-5
references.pmid: 18463276
references.citation: HERD. 2008 Spring;1(3):61-125
references.pmid: 21161908
references.citation: J Appl Physiol. 1954 Sep;7(2):218-21
references.pmid: 13211501
references.citation: J Rheumatol. 2009 Jun;36(6):1109-17
references.pmid: 19447940
references.citation: Health Qual Life Outcomes. 2003;1:64
references.pmid: 14613558
references.citation: Osteoarthritis Cartilage. 2009 Oct;17(10):1255-62
references.pmid: 19410027
references.citation: Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):550-5
references.pmid: 22773065
references.citation: Eval Health Prof. 2003 Jun;26(2):166-79
references.pmid: 12789710
references.citation: Psychosom Med. 2005 Jan-Feb;67(1):156-63
references.pmid: 15673638
references.citation: Am J Gastroenterol. 2000 Jul;95(7):1637-43
references.pmid: 10925962
references.citation: J Clin Epidemiol. 2002 Sep;55(9):900-8
references.pmid: 12393078
references.citation: Pain Pract. 2007 Mar;7(1):4-20
references.pmid: 17305673
references.citation: Ann Rheum Dis. 2005 Jan;64(1):34-7
references.pmid: 15130902
references.citation: BMC Med. 2010;8:18
references.pmid: 20334633
references.citation: J Clin Epidemiol. 2014 Jul;67(7):769-72
references.pmid: 24560088