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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| The Danish Rheumatism Association (funding) | UNKNOWN |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise in standard room | Active Comparator | 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. |
|
| Exercise in a contexually enhanced room | Experimental | 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. |
|
| Waiting list | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contextually enhanced physical surroundings of exercise | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in functional test: Single limb mini squat | Baseline, 8 weeks | |
| Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec. | baseline, 8 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise F. Sandal, MSc | Research Unit of Musculoskeletal Function and Physiotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark | Odense | 5230 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20565735 | Background | Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126. | |
| 28768617 | Derived | Sandal LF, Thorlund JB, Moore AJ, Ulrich RS, Dieppe PA, Roos EM. Room for improvement: a randomised controlled trial with nested qualitative interviews on space, place and treatment delivery. Br J Sports Med. 2019 Mar;53(6):359-367. doi: 10.1136/bjsports-2016-097448. Epub 2017 Aug 2. |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Neuromuscular exercise | Other | 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. |
|
| 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 |
| Change from baseline in functional test: Number of chair stands per. 30 sec. |
| baseline, 8 weeks |
| Change from baseline in functional test: Timed 40 m walking test | baseline, 8 weeks |
| Change from baseline in functional test: One leg hop for distance | Baseline, 8 weeks, |
| Change from baseline in muscle strength, MVC knee extension | baseline, 8 weeks |
| change from baseline in muscle strength, MVC, hip abduction | baseline, 8 weeks |
| Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin | Baseline, 8 weeks |
| 25818278 | Derived | Sandal LF, Thorlund JB, Ulrich RS, Dieppe PA, Roos EM. 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. BMJ Open. 2015 Mar 27;5(3):e007701. doi: 10.1136/bmjopen-2015-007701. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |