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

March 26, 2015 updated by: Louise Fleng Sandal, University of Southern Denmark

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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
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
change from baseline in muscle strength, MVC, hip abduction
Time Frame: baseline, 8 weeks
baseline, 8 weeks
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Louise F. Sandal, MSc, Research Unit of Musculoskeletal Function and Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

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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