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

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip; Joint Pain; Knee Pain; Hip Pain; Osteoarthritis, Knee
• Interventions: Other: Contextually enhanced physical surroundings of exercise; Other: Neuromuscular exercise

• Registration Number: NCT02043613
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

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.

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 Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Study Start: 2014-02
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise in a contexually enhanced room	Contextually enhanced physical surroundings of exercise	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.
Exercise in a contexually enhanced room	Neuromuscular exercise	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.
Exercise in standard room	Neuromuscular exercise	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.

Primary Outcome Measures

Name	Time	Method
Patients' Global Perceived Effect	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Arthritis Self-Efficacy Scale	baseline, 4 weeks, 8 weeks.	A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy
Patient satisfaction with physical surroundings	8 weeks	Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings.
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

Trial Locations

Locations (1)

Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark; 🇩🇰 Odense, Denmark