Context Effects in Exercise Therapy for Knee and/or Hip Pain

Study Overview
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Brief Summary
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The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.

Detailed Description
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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. Exercise in pre-existing, standard room Exercise in contextually enhanced room. 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.

Official Title
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Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial

Conditions
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Joint Pain, Knee Pain, Hip Pain, Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Other: Contextually enhanced physical surroundings of exercise
* Other: Neuromuscular exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 35 years or older Self-report of knee and/or hip pain within the last 3 months. Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly. Exclusion Criteria: Co-morbidities or contraindication prohibiting to participation in exercise therapy. Unable to fill-out questionnaires, or to speak, read or understand Danish. Already participating in exercise therapy*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise in standard room<br>Intervention: Exercise Patients exercise in standard physical surroundings. The room is marked by years of use. The room is placed in the basement, has artificial lighting, poor acoustics and bare concrete walls. | Other: Neuromuscular exercise<br>* 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.<br>|
| Experimental: Exercise in a contexually enhanced room<br>Intervention: Exercise + contextually enhanced physical surroundings Patients exercise in a contextually enhanced room. The room has both artificial lighting and daylight, view of a recreational park, better acoustics, decorations among other factors, which may cause or enhance the context effect. | Other: Contextually enhanced physical surroundings of exercise<br>* 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.<br>Other: Neuromuscular exercise<br>* 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.<br>|
| No Intervention: Waiting list<br>Patients on waiting list are included, baseline tested and placed on a waiting-list for a 8 week period and tested at 8 weeks follow-up. The group is representative of the natural cause of disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively |  | Baseline, 4 weeks, 8 weeks | 
| Change from baseline in The 36-item Short-Form Health Survey (SF-36) |  | 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 | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint pain, Context effects, Placebo effect, Exercise treatment