System Lupus Erythematosus(SLE)PALNCT07481214
Lupus Walking Intervention to Address Fatigue/Quality of Life
A study testing guided increases in daily walking in people with System Lupus Erythematosus(SLE), run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- System Lupus Erythematosus(SLE)
- What is being tested?
- guided increases in daily walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Planned surgery during the study period. Depending on the procedure and timing, these individuals may be eligible at a later date.
- Currently pregnant. While pregnancy does not prohibit exercise, it may lead to confounding of fatigue, either during pregnancy or after delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Walking Intervention to Improve Fatigue and Quality of Life in Lupus: A Randomized, Controlled Trial
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.
Read more
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)
- Being tested
- guided increases in daily walking
- Keywords
- systemic lupus erythematosus, physical activity, fatigue, quality of life
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided increases in daily walkingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: guided increases in daily walking |
| Waitlist control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity, measured as average steps/day
The Actigraph will provide step and activity data for 7 days at baseline, midpoint, and the final week of monitoring. These data will be aggregated to calculate an average number of steps/day and average daily time in moderate or vigorous activity, which will be used will be used as the primary measures of physical activity. The Actigraph also yields sedentary time, which can be used as a secondary measure of activity
Measured: From beginning to end of the intervention phase, approximately 20 weeks
Fatigue
Fatigue will be measured with the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue8a at baseline, mid-point, and the final week of monitoring. The scale is reported as T-scores, with mean of 50 and standard deviation of 10. T-scores range from 33.1 to 57.5, with higher scores reflecting greater fatigue.
The PROMIS Fatigue scale has been demonstrated to be valid and reliable in both English- and Spanish-speaking SLE patients. This scale is currently being used in our CLUES cohort, as shown in preliminary data. The minimal important change in the PROMIS Fatigue scale has been identified as ~3 points.
Measured: From beginning to end of intervention phase, approximately 20 weeks
Secondary outcomes (1)
quality of life
As secondary outcome measures, we will evaluate the impact of the intervention on pain, physical function, perceived cognitive function, depressive symptoms, anxiety, sleep disturbance, and overall quality of life measured with a lupus-specific questionnaire.
Measured: from beginning to end of intervention period, approximately 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jul 2022
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System Lupus Erythematosus(SLE)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Katz, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481214
- Sponsor's protocol ID
- LR200022
- Other IDs
- CDMRP-LR200022
- Acronym
- PAL
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the proposed project will be made available as follows: Approximately one year after the project has been completed and data have been cleaned and compiled, a link will be placed on the website for the Division of Rheumatology at UCSF so that researchers can request a copy of the data from the data manager. The data-sharing agreement will require recipients to acknowledge the source of the data if published and will prohibit recipients from transferring the data to other users. The data manager will send a compressed data set in one of several formats, along with a detailed codebook. All files will be sent electronically. Data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Walking Intervention to Improve Fatigue and Quality of Life in Lupus: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07481214
- Acronym / sponsor ID
- PAL / LR200022
- Conditions
- System Lupus Erythematosus(SLE)
- Keywords
- systemic lupus erythematosus, physical activity, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: guided increases in daily walkingThe 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. |
| Waitlist control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- 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.
- Planned surgery during the study period. Depending on the procedure and timing, these individuals may be eligible at a later date.
- Currently pregnant. While pregnancy does not prohibit exercise, it may lead to confounding of fatigue, either during pregnancy or after delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided increases in daily walkingThe 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. | Behavioural | Intervention |
Primary outcome
Physical activity, measured as average steps/day
Time frame: From beginning to end of the intervention phase, approximately 20 weeks
The Actigraph will provide step and activity data for 7 days at baseline, midpoint, and the final week of monitoring. These data will be aggregated to calculate an average number of steps/day and average daily time in moderate or vigorous activity, which will be used will be used as the primary measures of physical activity. The Actigraph also yields sedentary time, which can be used as a secondary measure of activity
Fatigue
Time frame: From beginning to end of intervention phase, approximately 20 weeks
Fatigue will be measured with the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue8a at baseline, mid-point, and the final week of monitoring. The scale is reported as T-scores, with mean of 50 and standard deviation of 10. T-scores range from 33.1 to 57.5, with higher scores reflecting greater fatigue. The PROMIS Fatigue scale has been demonstrated to be valid and reliable in both English- and Spanish-speaking SLE patients. This scale is currently being used in our CLUES cohort, as shown in preliminary data. The minimal important change in the PROMIS Fatigue scale has been identified as ~3 points.
1 secondary outcome
quality of life
Time frame: from beginning to end of intervention period, approximately 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Data from the proposed project will be made available as follows: Approximately one year after the project has been completed and data have been cleaned and compiled, a link will be placed on the website for the Division of Rheumatology at UCSF so that researchers can request a copy of the data from the data manager. The data-sharing agreement will require recipients to acknowledge the source of the data if published and will prohibit recipients from transferring the data to other users. The data manager will send a compressed data set in one of several formats, along with a detailed codebook. All files will be sent electronically. Data will be de-identified.
Related trials for System Lupus Erythematosus(SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Katz, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided increases in daily walking in people with System Lupus Erythematosus(SLE), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity, measured as average steps/day (time frame: From beginning to end of the intervention phase, approximately 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.