Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phone-Based Walk With Ease Program | Experimental | Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program |
|
| Delayed Phone-Based Walk With Ease Program | Other | Telephone-Based Walk With Ease Program starting after the 1 year assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone-Based Walk With Ease | Behavioral | 6 week phone-delivered Walk With Ease Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Baseline to 6 weeks |
| Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Baseline to 6 months |
| Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Baseline to 12 months |
| Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Baseline to 6 weeks |
| Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Baseline to 6 months |
| Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Baseline to 12 months |
| Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | Baseline to 6 weeks |
| Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Limitations | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
Not provided
| Label | URL |
|---|---|
| Study Website | View source |
Not provided
De-identified data will be made available within 30 months of the completion of the project.
Data will be made available within 30 months of the completion of the project.
open access
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phone Based Walk With Ease | 6 week phone-based Walk With Ease starting immediately after randomization |
| FG001 | Delayed Phone Based Walk With Ease | 6 week phone based Walk With Ease starting 12 months after randomization |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phone-Based Walk With Ease Program | Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program |
| BG001 | Delayed Phone-Based Walk With Ease Program | Telephone-Based Walk With Ease Program starting after the 1 year assessment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 weeks |
|
|
12 months
adverse events reported during the study including events unrelated to the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phone-Based Walk With Ease Program | Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee injury/swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Pellegrini | University of South Carolina | 803-777-0911 | pellegca@mailbox.sc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2023 | Feb 9, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D006073 | Gout |
| D005356 | Fibromyalgia |
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D008180 | Lupus Erythematosus, Systemic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C034430 | methyl hydroxyethyl cellulose |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | 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 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 | Baseline to 12 months |
| Change in Physical Activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Baseline to 6 weeks |
| Change in Physical Activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Baseline to 6 months |
| Change in Physical Activity | 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 | 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 | 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 | 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 | Diastolic blood pressure measured in mmHg | Baseline to 6 weeks |
| Change in Blood Pressure | Diastolic blood pressure measured in mmHg | Baseline to 6 months |
| Change in Blood Pressure | Diastolic blood pressure measured in mmHg | Baseline to 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Actigraph Measured moderate-vigorous intensity physical activity | Mean | Standard Deviation | minutes/week |
|
| Participants |
|
|
| Primary | Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
|
|
|
| Primary | Change in Pain | Visual analog scale (0mm no/low pain to 100 mm high pain) | Posted | Mean | 90% Confidence Interval | score on a scale | Baseline to 12 months |
|
|
|
| Primary | Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Posted | Mean | 95% Confidence Interval | repetitions | Baseline to 6 weeks |
|
|
|
| Primary | Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Posted | Mean | 95% Confidence Interval | repetitions | Baseline to 6 months |
|
|
|
| Primary | Change in Physical Function - Chair Stands | repetitions completed during 30 second chair stand test | Posted | Mean | 95% Confidence Interval | repetitions | Baseline to 12 months |
|
|
|
| Primary | Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | Posted | Mean | 95% Confidence Interval | feet | Baseline to 6 weeks |
|
|
|
| Primary | Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | Posted | Mean | 95% Confidence Interval | feet | Baseline to 6 months |
|
|
|
| Primary | Change in Physical Function - 6 Minute Walk | Distance walked (ft) during 6 minute walk test | Posted | Mean | 95% Confidence Interval | feet | Baseline to 12 months |
|
|
|
| Secondary | Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 weeks |
|
|
|
| Secondary | Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
|
|
|
| Secondary | Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
|
|
|
| Secondary | Change in Physical Activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Posted | Mean | 95% Confidence Interval | log(activity minutes) | Baseline to 6 weeks |
|
|
|
| Secondary | Change in Physical Activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Posted | Mean | 95% Confidence Interval | log(activity minutes) | Baseline to 6 months |
|
|
|
| Secondary | Change in Physical Activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Posted | Mean | 95% Confidence Interval | log(activity minutes) | Baseline to 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
|
|
|
| Secondary | Change in Blood Pressure | Diastolic blood pressure measured in mmHg | Posted | Mean | 95% Confidence Interval | mmHg | Baseline to 6 weeks |
|
|
|
| Secondary | Change in Blood Pressure | Diastolic blood pressure measured in mmHg | Posted | Mean | 95% Confidence Interval | mmHg | Baseline to 6 months |
|
|
|
| Secondary | Change in Blood Pressure | Diastolic blood pressure measured in mmHg | Posted | Mean | 95% Confidence Interval | mmHg | Baseline to 12 months |
|
|
|
| 0 |
| 132 |
| 3 |
| 132 |
| 37 |
| 132 |
| EG001 | Delayed Phone-Based Walk With Ease Program | Telephone-Based Walk With Ease Program starting after the 1 year assessment Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program | 0 | 135 | 0 | 135 | 28 | 135 |
| Aortic stenosis | Cardiac disorders | Systematic Assessment |
|
| Brain surgery to remove tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| mini stroke | Nervous system disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back injury/issue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Foot or ankle injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder injury or surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hip injury or surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| skin abrasions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eye injury/surgery | Eye disorders | Systematic Assessment |
|
| Heart condition or procedure | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal related diagnosis | Gastrointestinal disorders | Systematic Assessment |
|
| Aphasia | Nervous system disorders | Systematic Assessment |
|
| Breast cancer or related surgery | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Elevated blood glucose | Endocrine disorders | Systematic Assessment |
|
| Parkinsons disease diagnosis | Nervous system disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Hamstring injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D011686 |
| Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |