Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of South Carolina
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Physical function (6 Minute Walk Test)
Study Overview
Brief Summary
The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.
Detailed Description
All participants will be randomly assigned a physical activity goal (45 min/week, 90 min/week, or 150 min/week). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
- •Ability to read and write in English
Exclusion Criteria
- •Have any contraindications to exercise (besides arthritis)
- •Engage in ≥30 min/week of Actigraph assessed MVPA
- •Are pregnant, breastfeeding, or planning to become pregnant in the next year
- •Are planning to relocate out of the Columbia, SC area in the next 12 months,
- •Do not have a device compatible with Fitbit
- •Have uncontrolled hypertension (e.g., systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
- •Plan to have a surgery that affects mobility in the next 12 months
- •Have a serious cognitive impairment.
- •Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes/week).
Arms & Interventions
45 minutes/week
Participants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity
Intervention: DREAM Adaptive Intervention (Behavioral)
90 minutes/week
Participants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity
Intervention: DREAM Adaptive Intervention (Behavioral)
150 minutes/week
Participants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity
Intervention: DREAM Adaptive Intervention (Behavioral)
Outcomes
Primary Outcomes
Physical function (6 Minute Walk Test)
Time Frame: Baseline to 6 months
Change in distance walked during the 6 minute walk test
Secondary Outcomes
- Health Related Quality of Life - Physical(Baseline to 12 months)
- Physical function (6 Minute Walk Test)(Baseline to 12 months)
- Physical function (chair stands)(Baseline to 12 months)
- Health Related Quality of Life - Mental(Baseline to 12 months)
- Pain intensity(Baseline to 12 months)
- Depression symptoms(Baseline to 12 months)
- Physical function (chair stands)(Baseline to 6 months)
- Health Related Quality of Life - Physical(Baseline to 6 months)
- Health Related Quality of Life - Mental(Baseline to 6 months)
- Pain intensity(Baseline to 6 months)
- Depression symptoms(Baseline to 6 months)
Investigators
Christine A Pellegrini, PhD
Associate Professor
University of South Carolina