ArthritisPhase 3WWENCT00526435
Evaluation of Walk With Ease in Arthritis
A Phase 3 study testing Walk with Ease - Group and Walk with Ease - Self in people with Arthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Walk with Ease - Group and Walk with Ease - Self
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2010
- Phase
- Phase 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported, doctor-diagnosed arthritis
- Ages 18+
Who cannot join
- Non-English speaking
- Severe impairment of physical or mental function
- Co-existing condition for which exercise is contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluation of the Walk With Ease Program Among People With Arthritis
The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.
- Conditions
- Arthritis
- Being tested
- Walk with Ease - Group, Walk with Ease - Self
- Keywords
- Arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with Ease - GroupBehavioural
Participate in 6-week, 1 hour per week group assisted classes (with instructor).
Walk with Ease - SelfBehavioural
SUbject will receive the WWE workbook and follow it without group/instructor assistance.
| Study group | Role | What they receive |
|---|---|---|
| Group WWE | Experimental | Subjects will participate in a group-assisted 6 week WWE program. Receives: Behavioral: Walk with Ease - Group |
| Self-directed | Experimental | Subjects will follow the self-directed WWE program. Receives: Behavioral: Walk with Ease - Self |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Measured: 6 weeks
6-minute walk
Measured: 6 weeks
Walking behaviors
Measured: 6 weeks
Exercise self-efficacy
Measured: 6 weeks
Secondary outcomes (4)
Health-related Quality of Life (SF36)
Health Assessment Questionnaire
Arthritis Symptoms
Senior Fitness Test (function)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionJan 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina, Chapel Hill
- Investigators
- Jennifer M Hootman, PhD, Study director, Centers for Disease Control and PreventionLeigh F Callahan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526435
- Sponsor's protocol ID
- CDC-NCCDPHP-AAMC-0975
- Other IDs
- AAMC-0975
- Acronym
- WWE
- Status last verified
- Mar 2011
- First submitted
- 6 Sep 2007
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Walk With Ease Program Among People With Arthritis
- ClinicalTrials.gov ID
- NCT00526435
- Acronym / sponsor ID
- WWE / CDC-NCCDPHP-AAMC-0975
- Conditions
- Arthritis
- Keywords
- Arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Sep 2007 (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 overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group WWE | Experimental | Behavioral: Walk with Ease - GroupSubjects will participate in a group-assisted 6 week WWE program. |
| Self-directed | Experimental | Behavioral: Walk with Ease - SelfSubjects will follow the self-directed WWE program. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported, doctor-diagnosed arthritis
- Ages 18+
Key exclusion criteria (3 listed)
- Non-English speaking
- Severe impairment of physical or mental function
- Co-existing condition for which exercise is contraindicated
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 |
|---|---|---|
| Walk with Ease - GroupParticipate in 6-week, 1 hour per week group assisted classes (with instructor). | Behavioural | Group WWE |
| Walk with Ease - SelfSUbject will receive the WWE workbook and follow it without group/instructor assistance. | Behavioural | Self-directed |
Primary outcome
Physical Activity Level
Time frame: 6 weeks
6-minute walk
Time frame: 6 weeks
Walking behaviors
Time frame: 6 weeks
Exercise self-efficacy
Time frame: 6 weeks
4 secondary outcomes
Health-related Quality of Life (SF36)
Health Assessment Questionnaire
Arthritis Symptoms
Senior Fitness Test (function)
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 24 Mar 2011.
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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
Leigh F Callahan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Walk with Ease - Group and Walk with Ease - Self in people with Arthritis, 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 2 inclusion and 3 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 24 Mar 2011. 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 phase mean?
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 (time frame: 6 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 24 Mar 2011.