Lupus Walking Intervention to Address Fatigue/Quality of Life

Conditions

• System Lupus Erythematosus(SLE)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• guided increases in daily walking — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jul 1, 2022

Status verified

Apr 2026

Primary completion

Dec 15, 2025

Completion

Dec 15, 2025

Study Design

Enrollment

101 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Intervention
  The intervention group will receive a pedometer and instruction in monitoring their daily step counts using either an online portal (e.g., through REDCap) or a paper diary. We plan to use the Fitbit Inspire®, which is worn on the wrist as the pedometer. The intervention group will receive step targets for the study period based on their baseline week activity level. Step targets will be calculated to increase participants' average daily step counts by 10% for every 2 weeks of the intervention period. Participants who were initially randomized to the intervention group will be contacted by phone 4 months after the completion of their study period. The intent of this call is to assess whether they have continued with the activity program and whether they have continued to use the Fitbit in any other way.
• No Intervention: Waitlist control
  Controls will be told that they will be eligible to enter the intervention 20 weeks later. The control group will have follow-up contacts at the same times as the intervention group during the waitlist period to account for potential social effects of the intervention protocol. The control group will also be asked to undergo objective activity monitoring at the same time points as the intervention group.

Primary Outcome Measure

Physical activity, measured as average steps/day [ Time Frame: From beginning to end of the intervention phase, approximately 20 weeks ]

Locations (1)

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