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Completed

NCT Number: NCT02043613

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

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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Key information

Conditions

Joint Pain Arthralgia Arthritis Hip Pain Joint Diseases Knee Pain Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Odense, 5230, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contextually enhanced physical surroundings of exercise

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Change from baseline in The 36-item Short-Form Health Survey (SF-36)

    Time frame: Baseline, 4 weeks, 8 weeks

  3. 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

  4. 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.

Other outcomes

  1. Change from baseline in functional test: Single limb mini squat

    Time frame: Baseline, 8 weeks

  2. Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec.

    Time frame: baseline, 8 weeks

  3. Change from baseline in functional test: Number of chair stands per. 30 sec.

    Time frame: baseline, 8 weeks

  4. Change from baseline in functional test: Timed 40 m walking test

    Time frame: baseline, 8 weeks

  5. Change from baseline in functional test: One leg hop for distance

    Time frame: Baseline, 8 weeks,

  6. Change from baseline in muscle strength, MVC knee extension

    Time frame: baseline, 8 weeks

  7. change from baseline in muscle strength, MVC, hip abduction

    Time frame: baseline, 8 weeks

  8. Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin

    Time frame: Baseline, 8 weeks

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • The Danish Rheumatism Association (funding)
  • The Swedish Research Council

Registry information

Official study title

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

Acronym: CONEX

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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