Dose Response of Exercise for Arthritis Management

Not Applicable

Recruiting

• Conditions: Arthritis; Rheumatoid Arthritis (RA); Gout; Fibromyalgia (FM); Osteoarthritis; Lupus Erythematosus, Systemic

• Registration Number: NCT06880653
• Lead Sponsor: University of South Carolina

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 Timeline

• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-18
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2028-10-01
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 285

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical function (6 Minute Walk Test)	Baseline to 6 months	Change in distance walked during the 6 minute walk test

Secondary Outcome Measures

Name	Time	Method
Physical function (6 Minute Walk Test)	Baseline to 12 months	Change in distance walked during the 6 minute walk test
Physical function (chair stands)	Baseline to 12 months	Change in chair stand repetitions
Health Related Quality of Life - Physical	Baseline to 12 months	Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Health Related Quality of Life - Mental	Baseline to 12 months	Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Pain intensity	Baseline to 12 months	Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.
Depression symptoms	Baseline to 12 months	Change in depression symptoms using the CES-D. Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States