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Phone-Based Based Walk With Ease Program for Adults With Arthritis
NA trial testing Phone-Based Walk With Ease in Arthritis in 267 participants. Completed in 10 September 2024.
| Lead sponsor | University of South Carolina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 267 |
| Start date | 1 April 2022 |
| Primary completion | 10 September 2024 |
| Estimated completion | 10 September 2024 |
| Sites | 1 location across United States |
University of South Carolina
18 and older, any sex, with Arthritis or Gout. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Visual analog scale (0mm no/low pain to 100 mm high pain)
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease | -4.0 | -11.3 – 3.3 |
| Delayed Phone-Based Walk With Ease | -4.49 | -11.59 – 2.6 |
Visual analog scale (0mm no/low pain to 100 mm high pain)
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -1.04 | -8.99 – 6.92 |
| Delayed Phone-Based Walk With Ease Program | 0.35 | -7.05 – 7.76 |
Visual analog scale (0mm no/low pain to 100 mm high pain)
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -5.02 | -13.87 – 3.83 |
| Delayed Phone-Based Walk With Ease Program | -4.89 | -12.71 – 2.93 |
repetitions completed during 30 second chair stand test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | 0.98 | 0.43 – 1.52 |
| Delayed Phone-Based Walk With Ease Program | 0.48 | -0.08 – 1.04 |
repetitions completed during 30 second chair stand test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | 1.0 | 0.33 – 1.67 |
| Delayed Phone-Based Walk With Ease Program | 0.69 | 0.12 – 1.25 |
repetitions completed during 30 second chair stand test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | 0.79 | 0.13 – 1.45 |
| Delayed Phone-Based Walk With Ease Program | 0.45 | -0.16 – 1.06 |
Distance walked (ft) during 6 minute walk test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | 17.66 | -21.53 – 56.86 |
| Delayed Phone-Based Walk With Ease Program | -10.15 | -48.30 – 27.99 |
Distance walked (ft) during 6 minute walk test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -27.33 | -79.66 – 25.01 |
| Delayed Phone-Based Walk With Ease Program | 0.24 | -40.64 – 41.12 |
Distance walked (ft) during 6 minute walk test
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -21.32 | -76.30 – 33.67 |
| Delayed Phone-Based Walk With Ease Program | 2.19 | -40.78 – 45.16 |
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -0.09 | -0.15 – -0.04 |
| Delayed Phone-Based Walk With Ease Program | -0.05 | -0.12 – 0.01 |
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -0.05 | -0.12 – 0.01 |
| Delayed Phone-Based Walk With Ease Program | -0.02 | -0.1 – 0.05 |
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
| Group | Value | 95% CI |
|---|---|---|
| Phone-Based Walk With Ease Program | -0.06 | -0.12 – 0.01 |
| Delayed Phone-Based Walk With Ease Program | -0.02 | -0.08 – 0.04 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phone-Based Walk With Ease… | Delayed Phone-Based Walk W… |
|---|---|---|---|
| stroke | Vascular disorders | — | — |
| Aortic stenosis | Cardiac disorders | — | — |
| Brain surgery to remove tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Reaction | System | Phone-Based Walk With Ease… | Delayed Phone-Based Walk W… |
|---|---|---|---|
| Back injury/issue | Musculoskeletal and connective tissue disorders | — | — |
| Foot or ankle injury | Musculoskeletal and connective tissue disorders | — | — |
| Knee injury/swelling | Musculoskeletal and connective tissue disorders | — | — |
| Fall | Musculoskeletal and connective tissue disorders | — | — |
| car accident | Injury, poisoning and procedural complications | — | — |
| Knee replacement | Musculoskeletal and connective tissue disorders | — | — |
| Hip injury or surgery | Musculoskeletal and connective tissue disorders | — | — |
| Shoulder injury or surgery | Musculoskeletal and connective tissue disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| skin abrasions | Skin and subcutaneous tissue disorders | — | — |
| Heart condition or procedure | Cardiac disorders | — | — |
| Gastrointestinal related diagnosis | Gastrointestinal disorders | — | — |
| mini stroke | Nervous system disorders | — | — |
| Eye injury/surgery | Eye disorders | — | — |
| Aphasia | Nervous system disorders | — | — |
| Breast cancer or related surgery | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hysterectomy | Reproductive system and breast disorders | — | — |
| Elevated blood glucose | Endocrine disorders | — | — |
| Parkinsons disease diagnosis | Nervous system disorders | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — |
| Lightheadedness | General disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Hamstring injury | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: stroke, Aortic stenosis, Brain surgery to remove tumor.
Data from ClinicalTrials.gov NCT05289544 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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