Clinical trial NCT02043613: Context Effects in Exercise Therapy for Knee and/or Hip Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Knee Pain
Hip Pain
Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Joint pain
Context effects
Placebo effect
Exercise treatment
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: The Danish Rheumatism Association (funding)
First posted: 2014-01-23
Enrollment: 103
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Patients' Global Perceived Effect
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from baseline in The 36-item Short-Form Health Survey (SF-36)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change from baseline in Arthritis Self-Efficacy Scale
timeFrame: baseline, 4 weeks, 8 weeks.
measure: Patient satisfaction with physical surroundings
timeFrame: 8 weeks
Other outcomes:
measure: Change from baseline in functional test: Single limb mini squat
timeFrame: Baseline, 8 weeks
measure: Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec.
timeFrame: baseline, 8 weeks
measure: Change from baseline in functional test: Number of chair stands per. 30 sec.
timeFrame: baseline, 8 weeks
measure: Change from baseline in functional test: Timed 40 m walking test
timeFrame: baseline, 8 weeks
measure: Change from baseline in functional test: One leg hop for distance
timeFrame: Baseline, 8 weeks,
measure: Change from baseline in muscle strength, MVC knee extension
timeFrame: baseline, 8 weeks
measure: change from baseline in muscle strength, MVC, hip abduction
timeFrame: baseline, 8 weeks
measure: Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin
timeFrame: Baseline, 8 weeks
Locations:
city: Odense
country: Denmark
facility: Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Study officials:
affiliation: Research Unit of Musculoskeletal Function and Physiotherapy
name: Louise F. Sandal, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sandal LF, Thorlund JB, Moore AJ, Ulrich RS, Dieppe PA, Roos EM. Room for improvement: a randomised controlled trial with nested qualitative interviews on space, place and treatment delivery. Br J Sports Med. 2019 Mar;53(6):359-367. doi: 10.1136/bjsports-2016-097448. Epub 2017 Aug 2.
citation: Sandal LF, Thorlund JB, Ulrich RS, Dieppe PA, Roos EM. Exploring the effect of space and place on response to exercise therapy for knee and hip pain--a protocol for a double-blind randomised controlled clinical trial: the CONEX trial. BMJ Open. 2015 Mar 27;5(3):e007701. doi: 10.1136/bmjopen-2015-007701.