Exploring the effect of space and place on response to exercise therapy for knee and XXXX -a protocol for a double-blind randomised controlled clinical trial: the CONEX trial.

@entity1 @entity23 @entity85 @entity158
INTRODUCTION: 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 @entity85 . Although moderately effective overall, variation is seen in size of response to exercise across @entity23 ( @entity23 ) studies. Part of this variation may be related to the fact that exercise interventions are performed in different physical environments, which may affect @entity1 differently. The study aims to investigate the effect of exercising in a contextually enhanced physical environment for 8   weeks in @entity1 with knee or @entity158 . METHODS AND ANALYSIS: The study is a double-blind @entity23 . Eligible @entity1 are 35   years or older with persisting knee and/or @entity158 for 3   months. @entity1 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 @entity1 's global perceived effect rated on a seven-point Likert scale after 8   weeks exercise. @entity1 -reported and objective secondary outcomes are included. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02043613.
