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

Osteoarthritis, Knee Clinical Trial

— CONEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043613
• Other study ID #: S-20130130
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: March 26, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthralgia
• Hip Pain
• Joint Pain
• Knee Pain
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Swedish Research Council (funding), The Danish Rheumatism Association (funding)

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in functional test: Single limb mini squat		Baseline, 8 weeks	No
Other	Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec.		baseline, 8 weeks	No
Other	Change from baseline in functional test: Number of chair stands per. 30 sec.		baseline, 8 weeks	No
Other	Change from baseline in functional test: Timed 40 m walking test		baseline, 8 weeks	No
Other	Change from baseline in functional test: One leg hop for distance		Baseline, 8 weeks,	No
Other	Change from baseline in muscle strength, MVC knee extension		baseline, 8 weeks	No
Other	change from baseline in muscle strength, MVC, hip abduction		baseline, 8 weeks	No
Other	Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin		Baseline, 8 weeks	No
Primary	Patients' Global Perceived Effect	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	No
Secondary	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	No
Secondary	Change from baseline in The 36-item Short-Form Health Survey (SF-36)		Baseline, 4 weeks, 8 weeks	No
Secondary	Change from baseline in Arthritis Self-Efficacy Scale	A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy	baseline, 4 weeks, 8 weeks.	No
Secondary	Patient satisfaction with physical surroundings	Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings.	8 weeks	No