Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up.

NCT01063777 | Unknown

• 1 other identifier: 03c-2009-NAR
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long term effect of exercise therapy and patient education compared to patient education only in individuals with hip OA, and to evaluate predictive factors for changes in hip osteoarthritis both clinically and on x-ray. Main hypothesis H01: There are no significant long term ( 2 years) differences in hip function, quality of life, physical function and radiological changes between those individuals who went through a patient education program and a 12 week exercise therapy program compared to patient education program only. Material and Methods: 109 patients with radiographically verified hip OA are included in the randomized controlled trial; randomized to 12 week exercise therapy program and patient education (n=55) and patient education program only (n=54). Data will be collected 2 years after completed intervention period in the original RCT, and 6 months and 2 years postoperatively for those patients who have undergone total hip arthroplasty. The main outcome is: The Disease Specific WOMAC-Index. Secondary outcome measures are: Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion. Status: This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip artroplasty will continue throughout 2011. The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.

Conditions

Hip Osteoarthritis

Keywords

Hip Osteoarthritis, Exercise therapy, Patient Education

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, 12 weeks, 6, 12 and 24 months.

Secondary Outcomes (8)

• SF-36 (quality of life)

  Baseline, 12 weeks, 6, 12 and 24 months.

• PASE (activity score)

  Baseline, 12 weeks, 6, 12 and 24 months.

• Self-efficacy for pain

  Baseline, 12 weeks, 6, 12 and 24 months.

• Muscle strength tests

  Baseline, 12 weeks, 6 and 24 months.

• 6 minute walk test

  Baseline, 12 weeks, 6 and 24 months.

Study Arms (2)

1

ACTIVE COMPARATOR

Other: A 12 week exercise therapy program and patient education.

2

ACTIVE COMPARATOR

Other: Patient education

Interventions

A 12 week exercise therapy program and patient education. OTHER

The exercise protocol includes exercises from former studies on comparable patient populations. The intensity of the strength- and flexibility exercises meets the American College of Sports Medicine's (ACSM) recommendations for developing and maintaining muscular fitness in adults.Patients will be required to exercise for 60 minutes, three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) will be registered by the physical therapists. All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.

1

Patient education OTHER

All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.

2

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

Study Sites (1)

NAR-Orthopedic Centre, Ullevål University Hospital & Hjelp24 NIMI

Oslo, Norway

Location

Related Links

• Homepage NAR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

NO (1)