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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Southern Denmark
Sponsor:
Collaborators:
Swedish Research Council (funding)
University of Southern Denmark (funding)
The Danish Rheumatism Association (funding)
Information provided by (Responsible Party):
Louise Fleng Sandal, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02043613
First received: January 20, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Joint Pain
Knee Pain
Hip Pain
Osteoarthritis, Knee
Osteoarthritis, Hip
Other: Contextually enhanced physical surroundings of exercise
Other: Neuromuscular exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Patients' Global Perceived Effect [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in The 36-item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Arthritis Self-Efficacy Scale [ Time Frame: baseline, 4 weeks, 8 weeks. ] [ Designated as safety issue: No ]
    A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy

  • Patient satisfaction with physical surroundings [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec. [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in functional test: Number of chair stands per. 30 sec. [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in functional test: Timed 40 m walking test [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in functional test: One leg hop for distance [ Time Frame: Baseline, 8 weeks, ] [ Designated as safety issue: No ]
  • Change from baseline in muscle strength, MVC knee extension [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline in muscle strength, MVC, hip abduction [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043613

Contacts
Contact: Louise F. Sandal, MSc +4565504384 lsandal@health.sdu.dk
Contact: Ewa M. Roos, Professor, ph.d +4565504331 eroos@health.sdu.dk

Locations
Denmark
Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark Recruiting
Odense, Denmark, 5230
Contact: Louise F. Sandal, MSc    +4565504384    lsandal@health.sdu.dk   
Principal Investigator: Louise F. Sandal, MSc         
Sponsors and Collaborators
University of Southern Denmark
Swedish Research Council (funding)
University of Southern Denmark (funding)
The Danish Rheumatism Association (funding)
Investigators
Principal Investigator: Louise F. Sandal, MSc Research Unit of Musculoskeletal Function and Physiotherapy
  More Information

Publications:
Responsible Party: Louise Fleng Sandal, MSc, Ph.d student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02043613     History of Changes
Other Study ID Numbers: S-20130130
Study First Received: January 20, 2014
Last Updated: February 5, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Joint pain
Context effects
Placebo effect
Exercise treatment

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthralgia
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014