Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. a RCT.

NCT00319423 | Completed

• 1 other identifier: 03a-2005-NAR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Aims:

1. 1.Evaluate the effect of an exercise therapy program and patient education, versus patient education only, on hip function among patients with radiologically verified hip OA
2. 2.To identify biomechanical differences during gait, one-leg standing , and two-legged-raise analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.
3. 3.Patient Education, or
4. 4.Patient Education in addition to a supervised exercise program.

Conditions

Hip Osteoarthritis

Keywords

Hip Osteoarthritis, Exercise therapy, Patient Education

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  0, 4, 10, 16 months

Secondary Outcomes (8)

• SF-36 (quality of life)

  0, 4, 10, 16 months

• PASE (activity score)

  0, 4, 10, 16 months

• Self-efficacy for pain

  0, 4, 10, 16 months

• Muscle strength tests

  0, 4, 10 months

• Gait analysis (biomechanical analysis)

  0, 4 months

Study Arms (2)

Patient education

ACTIVE COMPARATOR

Patient education according to Klassbo et al 2003

Procedure: Patient education and supervised exercise

Patient education and supervised exercise

EXPERIMENTAL

Patient education according to Klassbo et al 2003. Supervised exercise containing strengthening, functional and flexibility exercises.

Procedure: Patient education and supervised exercise

Interventions

Patient education and supervised exercise PROCEDURE

Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks

Patient education; Patient education and supervised exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 40 and 80 years old with uni- or bilateral hip disability
• Harris Hip Score (36) between 60 and 95. Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for hip surgery (arthroplasty).
• Patients will be included if they have more than 3 months of hip pain.
• Patients with radiographic verified hip OA (Danielson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: \< 4 mm \< 70 years, \< 3 mm ≥ 70 years, or 1 mm difference between hips).

You may not qualify if:

• Patients have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
• Patients with co-morbidities not tolerating physical activities

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Norwegian Foundation for Health and Rehabilitation: collaborator

Study Sites (1)

NAR-Orthopedic Centre, Ullevål University Hospital & NIMI

Oslo, Oslo County, 0407, Norway

Location

Related Publications (5)

• Eitzen I, Fernandes L, Kallerud H, Nordsletten L, Knarr B, Risberg MA. Gait Characteristics, Symptoms, and Function in Persons With Hip Osteoarthritis: A Longitudinal Study With 6 to 7 Years of Follow-up. J Orthop Sports Phys Ther. 2015 Jul;45(7):539-49. doi: 10.2519/jospt.2015.5441. Epub 2015 May 21.

  PMID: 25996360 DERIVED

• Eitzen I, Fernandes L, Nordsletten L, Risberg MA. No effects of a 12-week supervised exercise therapy program on gait in patients with mild to moderate osteoarthritis: a secondary analysis of a randomized trial. J Negat Results Biomed. 2015 Mar 5;14:5. doi: 10.1186/s12952-015-0023-y.

  PMID: 25886499 DERIVED

• Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015 Jan;74(1):164-9. doi: 10.1136/annrheumdis-2013-203628. Epub 2013 Nov 19.

  PMID: 24255546 DERIVED

• Eitzen I, Fernandes L, Nordsletten L, Risberg MA. Sagittal plane gait characteristics in hip osteoarthritis patients with mild to moderate symptoms compared to healthy controls: a cross-sectional study. BMC Musculoskelet Disord. 2012 Dec 20;13:258. doi: 10.1186/1471-2474-13-258.

  PMID: 23256709 DERIVED

• Fernandes L, Storheim K, Sandvik L, Nordsletten L, Risberg MA. Efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis: a single blind randomized clinical trial. Osteoarthritis Cartilage. 2010 Oct;18(10):1237-43. doi: 10.1016/j.joca.2010.05.015. Epub 2010 Jul 13.

  PMID: 20633669 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• May Arna Risberg, PT, PhD

  NAR- Orthopedic Centre, Ullevål University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2005
• Primary Completion: February 1, 2009
• Last Updated: February 5, 2010

Record last verified: 2006-04

Locations

NO (1)