CompletedNot Applicable

Lupus Walking Intervention to Address Fatigue/Quality of Life

United States101 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Rheumatologists' diagnosis of SLE. Diagnoses will be confirmed in medical records before recruiting individuals in clinical settings. Diagnoses for all participants in the existing LOS and CLUES cohorts have already been verified.
. English or Spanish verbal fluency.
. Ability to travel to study site for the three in-person visits.
. Presence of ≥moderate levels of fatigue. The PROMIS Fatigue Short Form 8a will be administered for screening47. This scale is available in English and Spanish and has a raw score range of 0 - 32. Moderate fatigue will be defined as a raw score ≥12. In PARAFit, only \~11% of potential participants were screened out because of low levels of fatigue.

Exclusion criteria

. Currently engaging in regular exercise. Current exercise levels will be assessed with the short form of the International Physical Activity Questionnaire (IPAQ), a validated self-report measure of activity 48, during screening. Individuals meeting the IPAQ criterion for high activity will be excluded. For comparison, in one of our previous studies in SLE, fewer than 25% reported high levels of activity according to the IPAQ.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physical activity, measured as average steps/day

Timeframe: From beginning to end of the intervention phase, approximately 20 weeks

Fatigue

Timeframe: From beginning to end of intervention phase, approximately 20 weeks

Trial details

NCT IDNCT07481214

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More System Lupus Erythematosus(SLE) trials