Walk With Ease Program For Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— Walk SLE  

Official title:

Walk With Ease Program For Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631005
• Other study ID #: 15-2738
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 30, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physician diagnosis of systemic lupus erythematosus

• Age >/= 18

Exclusion Criteria:

• Age <18

• Engagement in >150 minutes of moderate-intensity activity at baseline

• Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score >8

• Pregnancy

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• "Walk With Ease"
Six-week walking program

Locations

Country	Name	City	State
United States	UNC Rheumatology Clinic	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

References & Publications (16)

Bartels 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. — View Citation

Bernatsky 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, Alarcón G, Senécal 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. — View Citation

Callahan LF, Shreffler JH, Altpeter M, Schoster B, Hootman J, Houenou LO, Martin KR, Schwartz TA. Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1098-107. doi: 10.1002/acr.20490. — View Citation

Carvalho 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. — View Citation

Clarke-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. — View Citation

Daltroy 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. — View Citation

Eriksson K, Svenungsson E, Karreskog H, Gunnarsson I, Gustafsson J, Möller S, Pettersson S, Boström 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. — View Citation

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. — View Citation

Lerang 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. — View Citation

Mancuso 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. — View Citation

Ramsey-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. — View Citation

Robb-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. — View Citation

Tench 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. Epub 2003 Apr 16. — View Citation

Trager J, Ward MM. Mortality and causes of death in systemic lupus erythematosus. Curr Opin Rheumatol. 2001 Sep;13(5):345-51. — View Citation

Ward 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. — View Citation

Yuen 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	Participant Satisfaction with Walk With Ease	This survey was designed by the Arthritis Foundation to assess participant satisfaction.	6 weeks