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Step by step: walking program shows promise for lupus fatigue
NCT ID NCT07481214
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a simple walking program using a pedometer could help reduce fatigue and improve quality of life in people with lupus. 101 participants were randomly assigned to either a walking group with personalized step goals or a wait-list control group. The program aimed to gradually increase daily steps over 21 weeks, with the goal of easing fatigue and improving other aspects of life like pain, sleep, and mood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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101 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. English or Spanish verbal fluency. 3. Ability to travel to study site for the three in-person visits. 4. 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: 1. 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. 2. Non-ambulatory or presence of a condition or comorbid disease that would limit the ability to engage in walking (e.g., myocardial infarction in past 6 months, stroke, congestive heart failure, severe chronic obstructive pulmonary disease). Individuals who are able to walk with an assistive device such as a cane will be eligible, per medical advice. 3. Planned surgery during the study period. Depending on the procedure and timing, these individuals may be eligible at a later date. 4. Currently pregnant. While pregnancy does not prohibit exercise, it may lead to confounding of fatigue, either during pregnancy or after delivery.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California San Francisco
San Francisco, California, 94143, United States
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