- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05289544
Phone-Based Based Walk With Ease Program for Adults With Arthritis
February 13, 2026 updated by: Christine A Pellegrini, PhD, University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
267
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- contraindications to exercise (besides arthritis)
- are pregnant, breastfeeding, or planning to become pregnant in the next year
- have a serious cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phone-Based Walk With Ease Program
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
6 week phone-delivered Walk With Ease Program
|
|
Other: Delayed Phone-Based Walk With Ease Program
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
6 week phone-delivered Walk With Ease Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain
Time Frame: Baseline to 6 weeks
|
Visual analog scale (0mm no/low pain to 100 mm high pain)
|
Baseline to 6 weeks
|
|
Change in Pain
Time Frame: Baseline to 6 months
|
Visual analog scale (0mm no/low pain to 100 mm high pain)
|
Baseline to 6 months
|
|
Change in Pain
Time Frame: Baseline to 12 months
|
Visual analog scale (0mm no/low pain to 100 mm high pain)
|
Baseline to 12 months
|
|
Change in Physical Function - Chair Stands
Time Frame: Baseline to 6 weeks
|
repetitions completed during 30 second chair stand test
|
Baseline to 6 weeks
|
|
Change in Physical Function - Chair Stands
Time Frame: Baseline to 6 months
|
repetitions completed during 30 second chair stand test
|
Baseline to 6 months
|
|
Change in Physical Function - Chair Stands
Time Frame: Baseline to 12 months
|
repetitions completed during 30 second chair stand test
|
Baseline to 12 months
|
|
Change in Physical Function - 6 Minute Walk
Time Frame: Baseline to 6 weeks
|
Distance walked (ft) during 6 minute walk test
|
Baseline to 6 weeks
|
|
Change in Physical Function - 6 Minute Walk
Time Frame: Baseline to 6 months
|
Distance walked (ft) during 6 minute walk test
|
Baseline to 6 months
|
|
Change in Physical Function - 6 Minute Walk
Time Frame: Baseline to 12 months
|
Distance walked (ft) during 6 minute walk test
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Limitations
Time Frame: Baseline to 6 weeks
|
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
|
Baseline to 6 weeks
|
|
Change in Physical Limitations
Time Frame: Baseline to 6 months
|
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
|
Baseline to 6 months
|
|
Change in Physical Limitations
Time Frame: Baseline to 12 months
|
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
|
Baseline to 12 months
|
|
Change in Physical Activity
Time Frame: Baseline to 6 weeks
|
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
|
Baseline to 6 weeks
|
|
Change in Physical Activity
Time Frame: Baseline to 6 months
|
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
|
Baseline to 6 months
|
|
Change in Physical Activity
Time Frame: Baseline to 12 months
|
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
|
Baseline to 12 months
|
|
Change in Arthritis Management Self-efficacy
Time Frame: Baseline to 6 weeks
|
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
|
Baseline to 6 weeks
|
|
Change in Arthritis Management Self-efficacy
Time Frame: Baseline to 6 months
|
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
|
Baseline to 6 months
|
|
Change in Arthritis Management Self-efficacy
Time Frame: Baseline to 12 months
|
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
|
Baseline to 12 months
|
|
Change in Blood Pressure
Time Frame: Baseline to 6 weeks
|
Diastolic blood pressure measured in mmHg
|
Baseline to 6 weeks
|
|
Change in Blood Pressure
Time Frame: Baseline to 6 months
|
Diastolic blood pressure measured in mmHg
|
Baseline to 6 months
|
|
Change in Blood Pressure
Time Frame: Baseline to 12 months
|
Diastolic blood pressure measured in mmHg
|
Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
September 10, 2024
Study Completion (Actual)
September 10, 2024
Study Registration Dates
First Submitted
March 11, 2022
First Submitted That Met QC Criteria
March 11, 2022
First Posted (Actual)
March 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Crystal Arthropathies
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Joint Diseases
- Rheumatic Diseases
- Purine-Pyrimidine Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Behavior
- Nutritional and Metabolic Diseases
- Skin and Connective Tissue Diseases
- Gout
- Arthritis
- Lupus Erythematosus, Systemic
- Osteoarthritis
- Fibromyalgia
- Arthritis, Rheumatoid
- Motor Activity
- methyl hydroxyethyl cellulose
Other Study ID Numbers
- Pro00115106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be made available within 30 months of the completion of the project.
IPD Sharing Time Frame
Data will be made available within 30 months of the completion of the project.
IPD Sharing Access Criteria
open access
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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