Arthritis, Fibromyalgia, Gout, Lupus Erythematosus, Systemic, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Arthritis, Physical activity, Intervention
Brief 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.
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.
Interventions
BEHAVIORALPhone-Based Walk With Ease
6 week phone-delivered Walk With Ease Program
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline to 6 weeks | Visual analog scale (0mm no/low pain to 100 mm high pain) |
| Change in Physical Function - Chair Stands | Baseline to 6 weeks | repetitions completed during 30 second chair stand test |
| Change in Physical Function - 6 Minute Walk | Baseline to 6 weeks | Distance walked (ft) during 6 minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Limitations | Baseline to 6 weeks | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability |
| Change in Physical Activity | Baseline to 6 weeks | total moderate and vigorous intensity physical activity (\>=2020 cpm) measured by Actigraph GT3x Link activity monitors |
| Change in Arthritis Management Self-efficacy | 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 |
| Change in Blood Pressure | Baseline to 6 weeks | Diastolic blood pressure measured in mmHg |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Actigraph Measured moderate-vigorous intensity physical activity | 51.32 minutes/week STANDARD_DEVIATION 10.36 |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 160 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 98 Participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 135 |
| other Total, other adverse events | 37 / 132 | 28 / 135 |
| serious Total, serious adverse events | 3 / 132 | 0 / 135 |
Outcome results
None listed