ArthritisNCT05289544
Phone-Based Based Walk With Ease Program for Adults With Arthritis
A study testing Phone-Based Walk With Ease in people with Arthritis and Gout, run by University of South Carolina at 1 site in United States.
Trial summary
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Gout, Fibromyalgia
- What is being tested?
- Phone-Based Walk With Ease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
- able to read and write in English
- plan to live in the Columbia, SC region for next year
- willing to be randomized to either group
- complete all baseline measure
Who cannot join
- contraindications to exercise (besides arthritis)
- are pregnant, breastfeeding, or planning to become pregnant in the next year
- have a serious cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Evaluating Alternative Delivery Models for Arthritis Self-management Interventions
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
Read the detailed description
Participants will be randomized to either start the 6-week program immediately or after one year. Our Walk with Ease by Telephone (WWE-T) program is adapted from the original 6-week community-based group walking program developed by the Arthritis Foundation for adults with arthritis. The phone-based program will include 2 phone calls each week with a trained Walk With Ease Leader for 6 weeks. Assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.
- Conditions
- Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, Lupus Erythematosus, Systemic
- Being tested
- Phone-Based Walk With Ease
- Keywords
- Arthritis, Physical activity, Intervention
- Medical subject headings
- Arthritis, Gout, Fibromyalgia, Arthritis, Rheumatoid, Osteoarthritis, Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-Based Walk With EaseBehavioural
6 week phone-delivered Walk With Ease Program
| Study group | Role | What they receive |
|---|---|---|
| Phone-Based Walk With Ease Program | Experimental | Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program Receives: Behavioral: Phone-Based Walk With Ease |
| Delayed Phone-Based Walk With Ease Program | Other | Telephone-Based Walk With Ease Program starting after the 1 year assessment Receives: Behavioral: Phone-Based Walk With Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Visual analog scale (0mm no/low pain to 100 mm high pain)
Measured: Baseline to 6 weeks
Change in Pain
Visual analog scale (0mm no/low pain to 100 mm high pain)
Measured: Baseline to 6 months
Change in Pain
Visual analog scale (0mm no/low pain to 100 mm high pain)
Measured: Baseline to 12 months
Change in Physical Function - Chair Stands
repetitions completed during 30 second chair stand test
Measured: Baseline to 6 weeks
Change in Physical Function - Chair Stands
repetitions completed during 30 second chair stand test
Measured: Baseline to 6 months
Change in Physical Function - Chair Stands
repetitions completed during 30 second chair stand test
Measured: Baseline to 12 months
Change in Physical Function - 6 Minute Walk
Distance walked (ft) during 6 minute walk test
Measured: Baseline to 6 weeks
Change in Physical Function - 6 Minute Walk
Distance walked (ft) during 6 minute walk test
Measured: Baseline to 6 months
Change in Physical Function - 6 Minute Walk
Distance walked (ft) during 6 minute walk test
Measured: Baseline to 12 months
Secondary outcomes (12)
Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Measured: Baseline to 6 weeks
Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Measured: Baseline to 6 months
Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Measured: Baseline to 12 months
Change in Physical Activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Measured: Baseline to 6 weeks
Change in Physical Activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Measured: Baseline to 6 months
Change in Physical Activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Measured: Baseline to 12 months
Change in Arthritis Management Self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Measured: Baseline to 6 weeks
Change in Arthritis Management Self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Measured: Baseline to 6 months
Change in Arthritis Management Self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Measured: Baseline to 12 months
Change in Blood Pressure
Diastolic blood pressure measured in mmHg
Measured: Baseline to 6 weeks
Change in Blood Pressure
Diastolic blood pressure measured in mmHg
Measured: Baseline to 6 months
Change in Blood Pressure
Diastolic blood pressure measured in mmHg
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Apr 2022
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289544
- Sponsor's protocol ID
- Pro00115106
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2022
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available within 30 months of the completion of the project.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Alternative Delivery Models for Arthritis Self-management Interventions
- ClinicalTrials.gov ID
- NCT05289544
- Acronym / sponsor ID
- Pro00115106
- Conditions
- Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, Lupus Erythematosus, Systemic
- Keywords
- Arthritis, Physical activity, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
Detailed description
Participants will be randomized to either start the 6-week program immediately or after one year. Our Walk with Ease by Telephone (WWE-T) program is adapted from the original 6-week community-based group walking program developed by the Arthritis Foundation for adults with arthritis. The phone-based program will include 2 phone calls each week with a trained Walk With Ease Leader for 6 weeks. Assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone-Based Walk With Ease Program | Experimental | Behavioral: Phone-Based Walk With EaseTelephone-based Walk With Ease Program adapted from the Arthritis Foundations program |
| Delayed Phone-Based Walk With Ease Program | Other | Behavioral: Phone-Based Walk With EaseTelephone-Based Walk With Ease Program starting after the 1 year assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
- able to read and write in English
- plan to live in the Columbia, SC region for next year
- willing to be randomized to either group
- complete all baseline measure
Key exclusion criteria (3 listed)
- contraindications to exercise (besides arthritis)
- are pregnant, breastfeeding, or planning to become pregnant in the next year
- have a serious cognitive impairment
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 |
|---|---|---|
| Phone-Based Walk With Ease6 week phone-delivered Walk With Ease Program | Behavioural | Delayed Phone-Based Walk With Ease Program, Phone-Based Walk With Ease Program |
Primary outcome
Change in Pain
Time frame: Baseline to 6 weeks
Visual analog scale (0mm no/low pain to 100 mm high pain)
Change in Pain
Time frame: Baseline to 6 months
Visual analog scale (0mm no/low pain to 100 mm high pain)
Change in Pain
Time frame: Baseline to 12 months
Visual analog scale (0mm no/low pain to 100 mm high pain)
Change in Physical Function - Chair Stands
Time frame: Baseline to 6 weeks
repetitions completed during 30 second chair stand test
Change in Physical Function - Chair Stands
Time frame: Baseline to 6 months
repetitions completed during 30 second chair stand test
Change in Physical Function - Chair Stands
Time frame: Baseline to 12 months
repetitions completed during 30 second chair stand test
Change in Physical Function - 6 Minute Walk
Time frame: Baseline to 6 weeks
Distance walked (ft) during 6 minute walk test
Change in Physical Function - 6 Minute Walk
Time frame: Baseline to 6 months
Distance walked (ft) during 6 minute walk test
Change in Physical Function - 6 Minute Walk
Time frame: Baseline to 12 months
Distance walked (ft) during 6 minute walk test
12 secondary outcomes
Change in Physical Limitations
Time frame: Baseline to 6 weeks
Change in Physical Limitations
Time frame: Baseline to 6 months
Change in Physical Limitations
Time frame: Baseline to 12 months
Change in Physical Activity
Time frame: Baseline to 6 weeks
Change in Physical Activity
Time frame: Baseline to 6 months
Change in Physical Activity
Time frame: Baseline to 12 months
Change in Arthritis Management Self-efficacy
Time frame: Baseline to 6 weeks
Change in Arthritis Management Self-efficacy
Time frame: Baseline to 6 months
Change in Arthritis Management Self-efficacy
Time frame: Baseline to 12 months
Change in Blood Pressure
Time frame: Baseline to 6 weeks
Change in Blood Pressure
Time frame: Baseline to 6 months
Change in Blood Pressure
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available within 30 months of the completion of the project.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-Based Walk With Ease in people with Arthritis and Gout, run by University of South Carolina 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 5 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 6 Mar 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain (time frame: Baseline to 6 weeks). The study lists 9 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 6 Mar 2026.