Walk With Ease Program For Patients With Systemic Lupus Erythematosus

NCT02631005 | Completed DMC

• 1 other identifier: 15-2738
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Participant Satisfaction with Walk With Ease

  6 weeks

Study Arms (1)

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.

Other: "Walk With Ease"

Interventions

"Walk With Ease" OTHER

Six-week walking program

Walk With Ease Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of systemic lupus erythematosus
• Age \>/= 18

You may not qualify if:

• Age \<18
• Engagement in \>150 minutes of moderate-intensity activity at baseline
• Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score \>8
• Pregnancy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Rheumatology Clinic

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (16)

• 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.

  PMID: 18163481 BACKGROUND

• 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. doi: 10.1089/jwh.2004.13.713.

  PMID: 15333286 BACKGROUND

• 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.

  PMID: 24532834 BACKGROUND

• 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, 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.

  PMID: 16868977 BACKGROUND

• 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.

  PMID: 25209070 BACKGROUND

• Trager 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.

  PMID: 11604587 BACKGROUND

• 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. doi: 10.1093/rheumatology/28.6.500.

  PMID: 2590802 BACKGROUND

• 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. doi: 10.1093/rheumatology/34.11.1064.

  PMID: 8542209 BACKGROUND

• 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. doi: 10.1002/1529-0131(200010)13:53.0.co;2-8.

  PMID: 14635294 BACKGROUND

• 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. doi: 10.1093/rheumatology/keg289. Epub 2003 Apr 16.

  PMID: 12730519 BACKGROUND

• 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. doi: 10.1002/art.21082. No abstract available.

  PMID: 15818657 BACKGROUND

• 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. doi: 10.1002/art.21605.

  PMID: 16342102 BACKGROUND

• 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.

  PMID: 21700656 BACKGROUND

• Eriksson 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.

  PMID: 22651371 BACKGROUND

• 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.

  PMID: 21183562 BACKGROUND

• 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.

  PMID: 21560255 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Saira Sheikh, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Leigh Callahan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Katherine Kaufman, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: March 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: August 30, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)