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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

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.

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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.

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Neuromuscular exercise

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Contextually enhanced physical surroundings of exercise

Intervention Type 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.

Neuromuscular exercise

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Contextually enhanced physical surroundings of exercise

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.

Intervention Type OTHER

Neuromuscular exercise

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.

Intervention Type OTHER

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)

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No