Clinical trial NCT06880653: Dose Response of Exercise for Arthritis Management
Official title: Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis
Rheumatoid Arthritis (RA)
Gout
Fibromyalgia (FM)
Osteoarthritis
Lupus Erythematosus, Systemic
Keywords: arthritis
exercise
physical activity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2025-03-18
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Physical function (6 Minute Walk Test)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Physical function (6 Minute Walk Test)
timeFrame: Baseline to 12 months
measure: Physical function (chair stands)
timeFrame: Baseline to 6 months
measure: Physical function (chair stands)
timeFrame: Baseline to 12 months
measure: Health Related Quality of Life - Physical
timeFrame: Baseline to 6 months
measure: Health Related Quality of Life - Physical
timeFrame: Baseline to 12 months
measure: Health Related Quality of Life - Mental
timeFrame: Baseline to 6 months
measure: Health Related Quality of Life - Mental
timeFrame: Baseline to 12 months
measure: Pain intensity
timeFrame: Baseline to 6 months
measure: Pain intensity
timeFrame: Baseline to 12 months
measure: Depression symptoms
timeFrame: Baseline to 6 months
measure: Depression symptoms
timeFrame: Baseline to 12 months
Other outcomes:
measure: Physical activity (min/week)
timeFrame: Baseline to 6 months
measure: Physical activity (min/week)
timeFrame: Baseline to 12 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Christine Pellegrini, PhD
role: PRINCIPAL_INVESTIGATOR
References: