Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rowland W. Chang, Northwestern University
ClinicalTrials.gov Identifier:
NCT00248105
First received: November 1, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Arthritis is a major cause of disability. Of the nearly 70 million persons in the US with arthritis and/or chronic joint symptoms, nearly 8 million are disabled because of their arthritis. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of its most common and disabling forms. Despite evidence that physical activity can improve functional and health related quality of life (HRQOL) outcomes and lower health care costs, the proportion of the US population engaging in the recommended amount of physical activity is low and even lower among those with arthritis. Moreover, there is considerable variation in clinicians' promotion of physical activity for arthritis clients. Care providers infrequently ask clients about their physical activity behavior and report feeling unprepared to promote physical activity.

This application studies the effects of a behavioral intervention aimed at promoting physical activity, including lifestyle physical activity, on arthritis-specific and generic HRQOL outcomes. The proposed physical activity management program (PAM) is based on a chronic care model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program is an individualized counseling and referral intervention, conducted by physical activity managers, directed by a theory-based comprehensive assessment of individual patient barriers and strengths related to physical activity performance. The specific aims of this randomized, controlled trial of 480 clients with RA and knee OA followed for 24 months are to test the effectiveness of physical activity management combined with physician physical activity promotion (PAM group) compared to physician physical activity promotion only (control group) in improving arthritis-specific and generic HRQOL, observed measures of function, and objectively measured and self-reported physical activity levels. In addition, exploratory analyses will be done to assess whether the improvements in HRQOL and physical activity performance associated with the PAM program are mediated by increases in physical activity levels and theory-based motivational variables, respectively. This study is intended to generate feasible methods by which health care providers and health care systems can increase physical activity levels in clients with arthritis and to result in widely applicable strategies for health behavior change.


Condition Intervention
Osteoarthritis, Knee
Rheumatoid Arthritis
Behavioral: Lifestyle Physical Activity Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Activity in Persons With Arthritis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 889
Study Start Date: September 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PAM Behavioral: Lifestyle Physical Activity Management
Lifestyle Physical Activity Promotion as given by Physical Activity Advocates. Advocates will meet with participants at baseline and every 3 months throughout the study to promote increase in lifestyle physical activity reached through goal setting and Motivational Interviewing (MI)
No Intervention: PC
Participants not in the PAM group will be in the PC (physician counseling) group and will receive advice on lifestyle physical activity from their rheumatologist or primary care physician.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 yrs. or older
  • ACR criteria for KOA or RA
  • Able to speak and read English
  • Able to ambulate at least household distances

Exclusion Criteria:

  • Planned total joint replacement surgery in the next 2 years
  • Contraindication to physical activity due to co-morbid condition
  • Unable to perform basic self-care (functional class IV) or walk household distances
  • Planned Relocation away from Chicago area in next two years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248105

Locations
United States, Illinois
NMFF
Chicago, Illinois, United States, 60611
Rehabilitation Institute Of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Rowland W. Chang, MD MPH Northwestern University, Feinberg School of Medicine
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rowland W. Chang, Professor of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University
ClinicalTrials.gov Identifier: NCT00248105     History of Changes
Other Study ID Numbers: 1 RO1 AR052912-01, R01AR052912-01
Study First Received: November 1, 2005
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Arthritis
Physical Activity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Osteoarthritis, Knee
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014