The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise. The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups. 1. Exercise in pre-existing, standard room 2. Exercise in contextually enhanced room. 3. Waiting list. The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality. The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups. Patients' "global perceived effect" is used as the primary outcome assessed at 8 weeks follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
103
Different physical surroundings of exercise may affects the patients differently and consequently influence the effect of exercise. The exercise rooms are different from each other on parameters such as source of lighting, acoustics, materials and decorations. The differences with the physical surroundings of exercise is the primary intervention for this study.
The neuromuscular exercise program is the same across the two exercise groups. Consequently, this intervention is not the primary intervention of this study. The exercise program is based on the previously reported NEMEX program designed for patients with hip or knee osteoarthritis, originally published by Ageberg et al, 2010 in BMCMusculoskeletal Disorders.
Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, Denmark
Patients' Global Perceived Effect
Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from "substantially worse" to "no change" to "substantially improved". The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement.
Time frame: 8 weeks
Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in The 36-item Short-Form Health Survey (SF-36)
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in Arthritis Self-Efficacy Scale
A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy
Time frame: baseline, 4 weeks, 8 weeks.
Patient satisfaction with physical surroundings
Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings.
Time frame: 8 weeks
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