Systemic Lupus ErythematosusWalk SLENCT02631005
Walk With Ease Program For Patients With Systemic Lupus Erythematosus
A study testing "Walk With Ease" in people with Systemic Lupus Erythematosus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- "Walk With Ease"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 30 Aug 2018
- 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
- Physician diagnosis of systemic lupus erythematosus
- Age >/= 18
Who cannot join
- Age <18
- Engagement in >150 minutes of moderate-intensity activity at baseline
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score >8
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Rheumatology Clinic
Chapel Hill, North Carolina, 27517
About this study
The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.
Read the detailed description
The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook, a publication of the Arthritis Foundation. Participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. The questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a FACIT-Fatigue form. Participants will also complete a satisfaction survey at the end of the program.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- "Walk With Ease"
- Keywords
- systemic lupus erythematosus, exercise
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Walk With Ease"Other
Six-week walking program
| Study group | Role | What they receive |
|---|---|---|
| Walk With Ease Participants | Experimental | Participants will receive a copy of the "Walk With Ease" workbook. This workbook provides guidance on walking safety and on how to start and maintain a regular walking program. It is designed to help participants increase their physical activity over a six-week period. Participants will complete self-reported outcomes questionnaires before and after completion of the program. Receives: Other: "Walk With Ease" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks
Pain scale ranges from 0 millimeters (mm) (no pain) to 100 mm (worst pain imaginable). An increase in score indicates worsening pain, while a decrease represents a response to the intervention.
Measured: 6 weeks
Change in VAS Stiffness Score from Baseline to Six Weeks
Stiffness scale ranges from 0 millimeters (mm) (no stiffness) to 100 mm (worst stiffness imaginable). An increase in score indicates worsening stiffness, while a decrease represents a response to the intervention.
Measured: 6 weeks
Change in VAS Fatigue Score from Baseline to Six Weeks
Fatigue scale ranges from 0 millimeters (mm) (no fatigue) to 100 mm (worst fatigue imaginable)An increase in score indicates worsening fatigue, while a decrease represents a response to the intervention.
Measured: 6 weeks
Change in FACIT-Fatigue Score from Baseline to Six Weeks
This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.
Measured: 6 weeks
Secondary outcomes (1)
Participant Satisfaction with Walk With Ease
This survey was designed by the Arthritis Foundation to assess participant satisfaction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionApr 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Saira Sheikh, MD, Principal investigator, University of North Carolina, Chapel HillLeigh Callahan, PhD, Principal investigator, University of North Carolina, Chapel HillKatherine Kaufman, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631005
- Sponsor's protocol ID
- 15-2738
- Acronym
- Walk SLE
- Status last verified
- Oct 2018
- First submitted
- 11 Dec 2015
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.
PubMed 18163481Ward MM. Prevalence of physician-diagnosed systemic lupus erythematosus in the United States: results from the third national health and nutrition examination survey. J Womens Health (Larchmt). 2004 Jul-Aug;13(6):713-8. doi: 10.1089/jwh.2004.13.713.
PubMed 15333286Bartels CM, Buhr KA, Goldberg JW, Bell CL, Visekruna M, Nekkanti S, Greenlee RT. Mortality and cardiovascular burden of systemic lupus erythematosus in a US population-based cohort. J Rheumatol. 2014 Apr;41(4):680-7. doi: 10.3899/jrheum.130874. Epub 2014 Feb 15.
PubMed 24532834Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.
PubMed 16868977Lerang K, Gilboe IM, Steinar Thelle D, Gran JT. Mortality and years of potential life loss in systemic lupus erythematosus: a population-based cohort study. Lupus. 2014 Dec;23(14):1546-52. doi: 10.1177/0961203314551083. Epub 2014 Sep 10.
PubMed 25209070Trager J, Ward MM. Mortality and causes of death in systemic lupus erythematosus. Curr Opin Rheumatol. 2001 Sep;13(5):345-51. doi: 10.1097/00002281-200109000-00002.
PubMed 11604587Robb-Nicholson LC, Daltroy L, Eaton H, Gall V, Wright E, Hartley LH, Schur PH, Liang MH. Effects of aerobic conditioning in lupus fatigue: a pilot study. Br J Rheumatol. 1989 Dec;28(6):500-5. doi: 10.1093/rheumatology/28.6.500.
PubMed 2590802Daltroy LH, Robb-Nicholson C, Iversen MD, Wright EA, Liang MH. Effectiveness of minimally supervised home aerobic training in patients with systemic rheumatic disease. Br J Rheumatol. 1995 Nov;34(11):1064-9. doi: 10.1093/rheumatology/34.11.1064.
PubMed 8542209Ramsey-Goldman R, Schilling EM, Dunlop D, Langman C, Greenland P, Thomas RJ, Chang RW. A pilot study on the effects of exercise in patients with systemic lupus erythematosus. Arthritis Care Res. 2000 Oct;13(5):262-9. doi: 10.1002/1529-0131(200010)13:53.0.co;2-8.
PubMed 14635294Tench CM, McCarthy J, McCurdie I, White PD, D'Cruz DP. Fatigue in systemic lupus erythematosus: a randomized controlled trial of exercise. Rheumatology (Oxford). 2003 Sep;42(9):1050-4. doi: 10.1093/rheumatology/keg289. Epub 2003 Apr 16.
PubMed 12730519Clarke-Jenssen AC, Fredriksen PM, Lilleby V, Mengshoel AM. Effects of supervised aerobic exercise in patients with systemic lupus erythematosus: a pilot study. Arthritis Rheum. 2005 Apr 15;53(2):308-12. doi: 10.1002/art.21082. No abstract available.
PubMed 15818657Carvalho MR, Sato EI, Tebexreni AS, Heidecher RT, Schenkman S, Neto TL. Effects of supervised cardiovascular training program on exercise tolerance, aerobic capacity, and quality of life in patients with systemic lupus erythematosus. Arthritis Rheum. 2005 Dec 15;53(6):838-44. doi: 10.1002/art.21605.
PubMed 16342102Yuen HK, Holthaus K, Kamen DL, Sword DO, Breland HL. Using Wii Fit to reduce fatigue among African American women with systemic lupus erythematosus: a pilot study. Lupus. 2011 Oct;20(12):1293-9. doi: 10.1177/0961203311412098. Epub 2011 Jun 23.
PubMed 21700656Eriksson K, Svenungsson E, Karreskog H, Gunnarsson I, Gustafsson J, Moller S, Pettersson S, Bostrom C. Physical activity in patients with systemic lupus erythematosus and matched controls. Scand J Rheumatol. 2012 Aug;41(4):290-7. doi: 10.3109/03009742.2011.624117. Epub 2012 May 31.
PubMed 22651371Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.
PubMed 21183562
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk With Ease Program For Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02631005
- Acronym / sponsor ID
- Walk SLE / 15-2738
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic lupus erythematosus, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- Mar 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Dec 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.
Detailed description
The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook, a publication of the Arthritis Foundation. Participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. The questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a FACIT-Fatigue form. Participants will also complete a satisfaction survey at the end of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walk With Ease Participants | Experimental | Other: "Walk With Ease"Participants will receive a copy of the "Walk With Ease" workbook. This workbook provides guidance on walking safety and on how to start and maintain a regular walking program. It is designed to help participants increase their physical activity over a six-week period. Participants will complete self-reported outcomes questionnaires before and after completion of the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician diagnosis of systemic lupus erythematosus
- Age >/= 18
Key exclusion criteria (4 listed)
- Age <18
- Engagement in >150 minutes of moderate-intensity activity at baseline
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score >8
- Pregnancy
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 |
|---|---|---|
| "Walk With Ease"Six-week walking program | Other | Walk With Ease Participants |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks
Time frame: 6 weeks
Pain scale ranges from 0 millimeters (mm) (no pain) to 100 mm (worst pain imaginable). An increase in score indicates worsening pain, while a decrease represents a response to the intervention.
Change in VAS Stiffness Score from Baseline to Six Weeks
Time frame: 6 weeks
Stiffness scale ranges from 0 millimeters (mm) (no stiffness) to 100 mm (worst stiffness imaginable). An increase in score indicates worsening stiffness, while a decrease represents a response to the intervention.
Change in VAS Fatigue Score from Baseline to Six Weeks
Time frame: 6 weeks
Fatigue scale ranges from 0 millimeters (mm) (no fatigue) to 100 mm (worst fatigue imaginable)An increase in score indicates worsening fatigue, while a decrease represents a response to the intervention.
Change in FACIT-Fatigue Score from Baseline to Six Weeks
Time frame: 6 weeks
This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.
1 secondary outcome
Participant Satisfaction with Walk With Ease
Time frame: 6 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 16 Oct 2018.
- Background: PubMed 18163481Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.
- Background: PubMed 15333286Ward MM. Prevalence of physician-diagnosed systemic lupus erythematosus in the United States: results from the third national health and nutrition examination survey. J Womens Health (Larchmt). 2004 Jul-Aug;13(6):713-8. doi: 10.1089/jwh.2004.13.713.
- Background: PubMed 24532834Bartels CM, Buhr KA, Goldberg JW, Bell CL, Visekruna M, Nekkanti S, Greenlee RT. Mortality and cardiovascular burden of systemic lupus erythematosus in a US population-based cohort. J Rheumatol. 2014 Apr;41(4):680-7. doi: 10.3899/jrheum.130874. Epub 2014 Feb 15.
- Background: PubMed 16868977Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.
- Background: PubMed 25209070Lerang K, Gilboe IM, Steinar Thelle D, Gran JT. Mortality and years of potential life loss in systemic lupus erythematosus: a population-based cohort study. Lupus. 2014 Dec;23(14):1546-52. doi: 10.1177/0961203314551083. Epub 2014 Sep 10.
- Background: PubMed 11604587Trager J, Ward MM. Mortality and causes of death in systemic lupus erythematosus. Curr Opin Rheumatol. 2001 Sep;13(5):345-51. doi: 10.1097/00002281-200109000-00002.
- Background: PubMed 2590802Robb-Nicholson LC, Daltroy L, Eaton H, Gall V, Wright E, Hartley LH, Schur PH, Liang MH. Effects of aerobic conditioning in lupus fatigue: a pilot study. Br J Rheumatol. 1989 Dec;28(6):500-5. doi: 10.1093/rheumatology/28.6.500.
- Background: PubMed 8542209Daltroy LH, Robb-Nicholson C, Iversen MD, Wright EA, Liang MH. Effectiveness of minimally supervised home aerobic training in patients with systemic rheumatic disease. Br J Rheumatol. 1995 Nov;34(11):1064-9. doi: 10.1093/rheumatology/34.11.1064.
- Background: PubMed 14635294Ramsey-Goldman R, Schilling EM, Dunlop D, Langman C, Greenland P, Thomas RJ, Chang RW. A pilot study on the effects of exercise in patients with systemic lupus erythematosus. Arthritis Care Res. 2000 Oct;13(5):262-9. doi: 10.1002/1529-0131(200010)13:53.0.co;2-8.
- Background: PubMed 12730519Tench CM, McCarthy J, McCurdie I, White PD, D'Cruz DP. Fatigue in systemic lupus erythematosus: a randomized controlled trial of exercise. Rheumatology (Oxford). 2003 Sep;42(9):1050-4. doi: 10.1093/rheumatology/keg289. Epub 2003 Apr 16.
- Background: PubMed 15818657Clarke-Jenssen AC, Fredriksen PM, Lilleby V, Mengshoel AM. Effects of supervised aerobic exercise in patients with systemic lupus erythematosus: a pilot study. Arthritis Rheum. 2005 Apr 15;53(2):308-12. doi: 10.1002/art.21082. No abstract available.
- Background: PubMed 16342102Carvalho MR, Sato EI, Tebexreni AS, Heidecher RT, Schenkman S, Neto TL. Effects of supervised cardiovascular training program on exercise tolerance, aerobic capacity, and quality of life in patients with systemic lupus erythematosus. Arthritis Rheum. 2005 Dec 15;53(6):838-44. doi: 10.1002/art.21605.
- Individual participant dataSharing planned: No
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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.
Saira Sheikh, MD principal investigator
University of North Carolina, Chapel Hill
Leigh Callahan, PhD principal investigator
University of North Carolina, Chapel Hill
Katherine Kaufman, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Walk With Ease" in people with Systemic Lupus Erythematosus, run by University of North Carolina, Chapel Hill 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 2 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 16 Oct 2018. 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?
Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631005, which also lists 16 linked publications.
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 16 Oct 2018.