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

NCT02043613 | Completed

• 1 other identifier: S-20130130
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Joint Pain; Knee Pain; Hip Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Joint pain; Context effects; Placebo effect; Exercise treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

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

  Baseline, 4 weeks, 8 weeks

• Change from baseline in Arthritis Self-Efficacy Scale

  baseline, 4 weeks, 8 weeks.

• Patient satisfaction with physical surroundings

  8 weeks

Other Outcomes (8)

• Change from baseline in functional test: Single limb mini squat

  Baseline, 8 weeks

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

  baseline, 8 weeks

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

  baseline, 8 weeks

Study Arms (3)

Exercise in standard room

ACTIVE COMPARATOR

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

Exercise in a contexually enhanced room

EXPERIMENTAL

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; Other: Neuromuscular exercise

Waiting list

NO INTERVENTION

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.

Interventions

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.

Exercise in a contexually enhanced room

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.

Exercise in a contexually enhanced room; Exercise in standard room

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead
• The Swedish Research Council: collaborator
• The Danish Rheumatism Association (funding): collaborator

Study Sites (1)

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

Odense, 5230, Denmark

Location

Related Publications (3)

• 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.

  PMID: 20565735 BACKGROUND

• 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.

  PMID: 28768617 DERIVED

• 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.

  PMID: 25818278 DERIVED

MeSH Terms

Conditions

Arthralgia; Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Louise F. Sandal, MSc

  Research Unit of Musculoskeletal Function and Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Ph.d student

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

DK (1)