NCT07481214

Lupus Walking Intervention to Address Fatigue/Quality of Life

A Walking Intervention to Improve Fatigue and Quality of Life in Lupus: A Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Fatigue is a major concern to individuals with lupus, persisting even when disease activity is clinically minimal, and impacting almost all quality of life domains. Studies show cross-sectional correlations between fatigue and physical activity levels in lupus. Some previous physical activity interventions have been tested in lupus and shown modest, although inconsistent, effects on fatigue. However, all of these interventions have been resource-intensive, requiring structured activities or special facilities, increasing barriers to access, dissemination, and widespread implementation. Focus Area: Improving quality of life for individuals living with lupus, with emphasis on symptom control and challenges that when addressed make day-to-day living with lupus easier and life more fulfilling. Objective and Hypotheses: The proposed study will test a simple pedometer-based walking intervention, based on an intervention previously implemented in rheumatoid arthritis with successful results in reducing fatigue. The intervention will address weaknesses in previous physical activity interventions in lupus that may have limited their impact. Hypothesis 1: Individuals in the intervention arm will achieve greater increases in physical activity than individuals in the control group. Hypothesis 2a: Individuals in the intervention arm will experience greater reductions in fatigue compared to baseline than the control group. Hypothesis 2b: Individuals in the intervention arm will experience greater improvements in other domains of quality of life (e.g., pain interference, perceived cognitive function, sleep disturbance, depression, anxiety) compared to baseline than the control group Hypothesis 2c: Greater increases in activity will be associated with greater reductions in fatigue and improvements in other domains of quality of life. Specific Aims Aim 1: Test the impact of a pedometer-based physical activity intervention on activity levels in persons with systemic lupus erythematosus (SLE) using a randomized controlled trial design. Aim 2: Test the impact of the physical activity intervention on fatigue levels and other domains of quality of life, including physical functioning, pain interference, depressive symptoms, cognitive symptoms, social functioning, and sleep disturbance, in persons with SLE. Research Strategy: We will test the effect of a walking intervention on increasing physical activity and decreasing fatigue, as well as improving other aspects of quality of life. After objective assessments of physical activity at baseline, participants will be randomized to one of two groups (n = 57 in each group): an intervention group that will receive a pedometer/activity monitor plus individualized step targets or a wait-list control group. The intervention will direct gradual increases in activity; specifically, increases of 10% every two weeks, initially based on the baseline activity assessment. Both groups will be followed over 21 weeks with the same measurements and contacts. Objective measurements of activity will be repeated at weeks 10 and 20. At the end of the 21-week period, the wait-list control group will begin the intervention. The intervention group will have a follow-up 4 months after the end of the intervention to assess maintenance of activity, fatigue, and other quality of life domains. The proposed study will leverage two existing cohort studies and two active lupus clinics for recruitment and an intervention protocol successfully implemented in a study targeting fatigue in rheumatoid arthritis. The study team is uniquely qualified to perform the proposed work, including investigators with expertise in clinical studies of lupus, clinical care of persons with lupus, design and implementation of physical activity interventions, objective measurement of activity, and design and analysis of clinical trial data.

Conditions

• System Lupus Erythematosus(SLE)

Interventions

Type	Name	Description
BEHAVIORAL	guided increases in daily walking	The intervention entails increasing participants' average daily step counts by 10% for every 2 weeks of the intervention period. These target increases will be relatively small for each period, yet will yield a substantial increase by the end of the study period.

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2026-03-18
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States