Community-Based Programs for Improving Physical Function in People With Early Knee Osteoarthritis

NCT00586300 | Completed

• 1 other identifier: R01AR047595
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of arthritis in the United States. Pain relievers and anti-inflammatory medications are the most commonly prescribed treatments for OA. These medications, however, cannot completely alleviate OA symptoms. Additional recommended strategies for managing OA include physical and occupational therapy, exercise, and patient education. This study will compare the effectiveness of a physical training program, a self-management training program, and a program including both physical and self-management training for improving physical function in people with early stage knee OA.

Conditions

Osteoarthritis

Keywords

Knee pain

Outcome Measures

Primary Outcomes (1)

• Knee function, as measured by the ERGOS machine

  Measured at baseline and Months 9 and 24

Secondary Outcomes (7)

• Pain, as measured by the visual analogue scale (VAS) and the Pain Subscale of the Western Ontario and MacMasters Universities (WOMAC)

  Measured at baseline and Months 3, 9, 18, and 24

• Coping efficacy, self-efficacy, and health-related quality of life, as measured by the Client Satisfaction Questionnaire (CSQ)

  Measured at baseline and Months 3, 9, 18, and 24

• Arthritis self-efficacy scale

  Measured at baseline and Months 3, 9, 18, and 24

• Positive and Negative Affect Schedule (PANAS)

  Measured at baseline and Months 3, 9, 18, and 24

• SF-36 Health Survey

  Measured at baseline and Months 3, 9, 18, and 24

Study Arms (3)

1

ACTIVE COMPARATOR

Physical training program

Other: Physical training program

2

ACTIVE COMPARATOR

Self-management training program

Behavioral: Self-management training program

3

ACTIVE COMPARATOR

Physical and self-management training programs

Other: Physical training and self-management training programs

Interventions

Physical training program OTHER

The physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis.

Also known as: Exercise group

1

Self-management training program BEHAVIORAL

The self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry.

2

Physical training and self-management training programs OTHER

This "multidimensional" intervention will combine both the physical training and self-management training programs described for Groups 1 and 2.

Also known as: Combo Group

3

Eligibility Criteria

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

You may qualify if:

• History of pain on most days (i.e., 4 or more days in a week) in one or both knees for at least 4 months during the year prior to study entry
• Duration of symptoms (defined as pain on most days for at least 4 months in 1 year) of less than 5 years
• Radiographic evidence of grade II knee OA
• Some level of disability, represented as a score of 3 or higher for at least three of the following WOMAC Index items: descending or ascending stairs; walking; bending; and performing daily activities

You may not qualify if:

• Any uncontrolled medical condition that could prevent safe participation in the study (e.g., uncontrolled heart disease, blood pressure, or respiratory conditions)
• Any neurological condition that could affect coordination
• Inflammatory arthritis (e.g., rheumatoid or psoriatic arthritis)
• Participates in aerobic activity or resistance training for more than 60 minutes per week
• History of knee surgery
• Radiographic grade I, III-IV (Kellgren and Lawrence classification)
• Body mass index of at most 37.5 Kg/m2 (Individuals over this limit will be advised to follow a weight loss program and achieve stable weight for 6 months prior to participation.)
• History of a knee corticosteroid injection in the 3 months prior to study entry
• Plans to move from the local area
• Plans to become pregnant during the study

Sponsors & Collaborators

• University of Arizona: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85722-3308, United States

Location

Related Publications (4)

• Wright LJ, Zautra AJ, Going S. Adaptation to early knee osteoarthritis: the role of risk, resilience, and disease severity on pain and physical functioning. Ann Behav Med. 2008 Aug;36(1):70-80. doi: 10.1007/s12160-008-9048-5. Epub 2008 Aug 21.

  PMID: 18716855 RESULT

• McKnight PE, Kasle S, Going S, Villanueva I, Cornett M, Farr J, Wright J, Streeter C, Zautra A. A comparison of strength training, self-management, and the combination for early osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jan 15;62(1):45-53. doi: 10.1002/acr.20013.

  PMID: 20191490 DERIVED

• Farr JN, Going SB, McKnight PE, Kasle S, Cussler EC, Cornett M. Progressive resistance training improves overall physical activity levels in patients with early osteoarthritis of the knee: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):356-66. doi: 10.2522/ptj.20090041. Epub 2010 Jan 7.

  PMID: 20056719 DERIVED

• Farr JN, Going SB, Lohman TG, Rankin L, Kasle S, Cornett M, Cussler E. Physical activity levels in patients with early knee osteoarthritis measured by accelerometry. Arthritis Rheum. 2008 Sep 15;59(9):1229-36. doi: 10.1002/art.24007.

  PMID: 18759320 DERIVED

Related Links

• Click here for more information about the Knee Study

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Scott B. Going, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 4, 2008
• Study Start: June 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

US (1)