Clinical trial NCT00146393: Health Benefits of an Exercise Program for Adults With Arthritis
Official title: Evaluation of People With Arthritis Can Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis
Osteoarthritis
Rheumatoid Arthritis
Keywords: exercise
physical activity
physical conditioning
pain
physical function
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of North Carolina
First posted: 2005-09-07
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to assess the effect of People with Arthritis Can Exercise (PACE), a community-based group recreational exercise program, on key arthritis-related health outcomes among adults with arthritis.

Detailed description: Self-management is very important in chronic diseases, and promoting physical activity is a key public health strategy for arthritis management. Although several exercise programs such as People with Arthritis Can Exercise (PACE) have been created to implement this strategy, none have sufficient scientific evidence supporting their effectiveness to promote the programs through public health avenues.

The primary goal of this study is to assess the effect of PACE(People with Arthritis Can Exercise), a community-based group recreational exercise program, on key arthritis-related health outcomes. The primary goal of the study will be accomplished through an eight week randomized controlled trial conducted with 480 participants residing in eight urban or rural communities in North Carolina. This project is designed to evaluate the effectiveness of the program in changing arthritis-related health outcomes such as pain, function and physical activity levels. The project will compare the eight week PACE program to a control group.

The specific objectives are as follows: (The aims have not been modified.)

1. To further review the PACE conceptual framework and materials in order to develop a standardized PACE protocol to be delivered in the study as well as to refine study measures.
2. To work closely with the Carolinas AF Chapter to develop collaborative relationships with local health departments and key contacts in communities identified for PACE implementation.
3. To recruit 480 individuals to participate in a randomized controlled trial of PACE in eight communities and to implement the PACE program.
4. To compare changes in key arthritis-related health outcomes between PACE participants and controls over eight weeks (PACE course time frame).
5. To determine longer-term benefits of the PACE intervention by examining key arthritis-related health outcomes 3 and 6 months post completion of the intervention.
6. To conduct qualitative research among PACE completers and non-completers to determine motivators and barriers to success, as well as to determine the acceptability and suitability of the program.
7. To formulate recommendations or modifications for implementation of the PACE program.

Eligibility criteria: Inclusion Criteria:

* Adults over age 18
* Have some form of arthritis (examples: osteoarthritis, rheumatoid arthritis, lupus, fibromyalgia, gout, etc.)
* Be able to move independently without assistance
* Currently exercising less than 3 times per week

Exclusion Criteria:

* Inability to walk without assistance
* Severe health condition where exercise is contraindicated

Primary outcomes:
measure: Visual Analog Scale pain level at baseline, 2, 3 and 6 months
measure: Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months
measure: Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months
measure: Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months
Secondary outcomes:
measure: Visual analog scale fatigue
measure: Visual analog scale stiffness
measure: Rheumatoid Arthritis Self-efficacy Scale (RASE)
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
measure: Outcomes Expectations for Exercise (OEE)
measure: COnfidence Self-efficacy (CSE)
measure: Rheumatology Attitudes Index (RAI)
measure: Tampa Scale for Kinesiophobia (TSK)
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Leigh Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoster B, Callahan LF, Meier A, Mielenz T, DiMartino L. The People with Arthritis Can Exercise (PACE) program: a qualitative evaluation of participant satisfaction. Prev Chronic Dis. 2005 Jul;2(3):A11. Epub 2005 Jun 15.
citation: Callahan LF, Mielenz T, Freburger J, Shreffler J, Hootman J, Brady T, Buysse K, Schwartz T. A randomized controlled trial of the people with arthritis can exercise program: symptoms, function, physical activity, and psychosocial outcomes. Arthritis Rheum. 2008 Jan 15;59(1):92-101. doi: 10.1002/art.23239.