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ArthritisPhase 2/3NCT00146393

Health Benefits of an Exercise Program for Adults With Arthritis

A Phase 2/3 study testing People with Arthritis Can Exercise program in people with Arthritis and Osteoarthritis, run by Centers for Disease Control and Prevention.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Osteoarthritis, Rheumatoid Arthritis
What is being tested?
People with Arthritis Can Exercise program
How many people
347 participants
Where
No sites listed yet
Study dates
Jul 2003to Jun 2004
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Evaluation of People With Arthritis Can Exercise

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.

Read the 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.
Being tested
People with Arthritis Can Exercise program
Keywords
exercise, physical activity, physical conditioning, pain, physical function
Medical subject headings
Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • People with Arthritis Can Exercise programBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale pain level at baseline, 2, 3 and 6 months

  2. Self-reported physical function (Health Assessment Questionnaire) at baseline, and 2, 3 and 6 months

  3. Measured function (6 minute walk, 360 deg turn, walking speed and timed chair stands, 10 lb lift) at baseline and 2 months

  4. Physical activity level (Physical Activity Scale for the Elderly : PASE) at baseline, 2, 3 and 6 months

Secondary outcomes (8)

  1. Visual analog scale fatigue

  2. Visual analog scale stiffness

  3. Rheumatoid Arthritis Self-efficacy Scale (RASE)

  4. Center for Epidemiologic Studies Depression Scale (CES-D)

  5. Outcomes Expectations for Exercise (OEE)

  6. COnfidence Self-efficacy (CSE)

  7. Rheumatology Attitudes Index (RAI)

  8. Tampa Scale for Kinesiophobia (TSK)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startJul 2003
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
347 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146393
Sponsor's protocol ID
CDC-NCCDPHP-0275
Other IDs
CDC-PEP-MM0275
Status last verified
Sep 2005
First submitted
2 Sep 2005
Last updated
9 Dec 2005
Results posted
No

Publications

  • 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.

    PubMed 15963313

  • 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.

    PubMed 18163409

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing People with Arthritis Can Exercise program in people with Arthritis and Osteoarthritis, run by Centers for Disease Control and Prevention.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale pain level at baseline, 2, 3 and 6 months. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146393, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2005.

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