Clinical trial NCT00153309: Program Evaluation of People With Arthritis Can Exercise
Official title: Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis
Osteoarthritis
Rheumatoid Arthritis
Keywords: arthritis
exercise
physical activity
physical function
pain
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Missouri-Columbia
name: St. Louis University
First posted: 2005-09-12
Enrollment: 320
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 purpose of this study is to evaluate the health and arthritis-specific benefits of participation in the Arthritis Foundation People with Arthritis Can Exercise program and to collect information to improve community-based dissemination of this program.

Detailed description: Only about 24% of people with arthritis report sufficient physical activity to provide general health benefits. Research has demonstrated that many people with arthritis can safely exercise to improve fitness and health. The People with Arthritis Can Exercise (PACE) program, developed by the Arthritis Foundation, is a land-based recreational physical activity and exercise program. PACE has been offered as a community-based program for over 10 years and small studies have reported benefits for people with arthritis. However, there has been no randomized controlled community trials that evaluate the effectiveness of PACE in the community. The goals of the Evaluation of PACE project are to: (1) appropriately evaluate the AF PACE exercise program, and (2) provide information to support effective content, recruitment and programming. Specific objectives for meeting these goals include:

1. Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;
2. Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;
3. Perform a qualitative evaluation using focus groups of PACE instructors and participants;
4. Disseminate findings and make recommendations.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 and older
* Self-reported arthritis or chronic joint symptoms
* Community-dwelling

Exclusion Criteria:

* Serious medical conditions which would contraindicate exercise
* No severe physical or mental condition

Primary outcomes:
measure: Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
measure: Pain Visual Analog Scale - at baseline, 8 and 16 weeks
measure: Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
measure: Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary outcomes:
measure: Health-related quality of life
measure: Disease status
measure: Self-efficacy for arthritis management
measure: Self-efficacy for exercise
measure: Social support
measure: Depressive symptoms
measure: Anxiety
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_DIRECTOR
affiliation: University of Missouri-Columbia
name: Marian Minor, PhD
role: PRINCIPAL_INVESTIGATOR
References: