- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043613
Context Effects in Exercise Therapy for Knee and/or Hip Pain (CONEX)
Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Odense, Denmark, 5230
- Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise in standard room
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. |
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.
|
Experimental: Exercise in a contexually enhanced room
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. |
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.
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. |
No Intervention: Waiting list
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' Global Perceived Effect
Time Frame: 8 weeks
|
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
Time Frame: Baseline, 4 weeks, 8 weeks
|
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
|
Baseline, 4 weeks, 8 weeks
|
|
Change from baseline in Arthritis Self-Efficacy Scale
Time Frame: baseline, 4 weeks, 8 weeks.
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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
Time Frame: 8 weeks
|
Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings.
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8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in functional test: Single limb mini squat
Time Frame: Baseline, 8 weeks
|
Baseline, 8 weeks
|
Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec.
Time Frame: baseline, 8 weeks
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baseline, 8 weeks
|
Change from baseline in functional test: Number of chair stands per. 30 sec.
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
Change from baseline in functional test: Timed 40 m walking test
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
|
Change from baseline in functional test: One leg hop for distance
Time Frame: Baseline, 8 weeks,
|
Baseline, 8 weeks,
|
Change from baseline in muscle strength, MVC knee extension
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
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change from baseline in muscle strength, MVC, hip abduction
Time Frame: baseline, 8 weeks
|
baseline, 8 weeks
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Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin
Time Frame: Baseline, 8 weeks
|
Baseline, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louise F. Sandal, MSc, Research Unit of Musculoskeletal Function and Physiotherapy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20130130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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