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

Sponsor

University of Southern Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02043613

Collaborator

The Swedish Research Council (Other), The Danish Rheumatism Association (funding) (Other)

103

Enrollment

Location

Arms

12.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Joint Pain Knee Pain Hip Pain Osteoarthritis, Knee Osteoarthritis, Hip	Other: Contextually enhanced physical surroundings of exercise Other: Neuromuscular exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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.	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.
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.	Other: 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. 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.
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.

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.

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.

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.

Other: 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.

Other: Neuromuscular exercise

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.

Outcome Measures

Primary Outcome Measures

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

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 [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.

Other Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark	Odense		Denmark	5230