ArthritisPhase 2/3NCT00153309
Program Evaluation of People With Arthritis Can Exercise
A Phase 2/3 study testing People with Arthritis Can Exercise in people with Arthritis and Osteoarthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial 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. 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
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2005
- 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 age 18 and older
- Self-reported arthritis or chronic joint symptoms
- Community-dwelling
Who cannot join
- Serious medical conditions which would contraindicate exercise
- No severe physical or mental condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
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.
Read the 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:
- Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;
- Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;
- Perform a qualitative evaluation using focus groups of PACE instructors and participants;
- Disseminate findings and make recommendations.
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Being tested
- People with Arthritis Can Exercise
- Keywords
- arthritis, exercise, physical activity, physical function, pain
- 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 ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Self-reported function (HAQ) at baseline, 8 and 16 weeks
Secondary outcomes (7)
Health-related quality of life
Disease status
Self-efficacy for arthritis management
Self-efficacy for exercise
Social support
Depressive symptoms
Anxiety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 320 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Missouri-Columbia, St. Louis University
- Investigators
- Jennifer M Hootman, PhD, Study director, Centers for Disease Control and PreventionMarian Minor, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153309
- Sponsor's protocol ID
- CDC-NCCDPHP-0507
- Other IDs
- CDC-NCCDPHP-MM-0507
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 17 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Health Benefits of the People With Arthritis Can Exercise Program
- ClinicalTrials.gov ID
- NCT00153309
- Acronym / sponsor ID
- CDC-NCCDPHP-0507
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Keywords
- arthritis, exercise, physical activity, physical function, pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Missouri-Columbia, St. Louis University
- Study start
- Jun 2003
- Study completion
- Jun 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures;
- Plan and conduct a randomized controlled trial of 8 and 16 week PACE programs;
- Perform a qualitative evaluation using focus groups of PACE instructors and participants;
- Disseminate findings and make recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 and older
- Self-reported arthritis or chronic joint symptoms
- Community-dwelling
Key exclusion criteria (2 listed)
- Serious medical conditions which would contraindicate exercise
- No severe physical or mental condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| People with Arthritis Can Exercise | Behavioural | – |
Primary outcome
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.
Pain Visual Analog Scale - at baseline, 8 and 16 weeks
Physical Function using the Functional Fitness Battery at baseline, 8 and 16 weeks
Self-reported function (HAQ) at baseline, 8 and 16 weeks
7 secondary outcomes
Health-related quality of life
Disease status
Self-efficacy for arthritis management
Self-efficacy for exercise
Social support
Depressive symptoms
Anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Hootman, PhD study director
Centers for Disease Control and Prevention
Marian Minor, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing People with Arthritis Can Exercise in people with Arthritis and Osteoarthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
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 3 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 17 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Physical Activity Level - PASE instrument at baseline, 8 and 16 weeks.. 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?
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 17 Nov 2005.