Physical Therapy for Systemic Lupus Erythematosus (SLE)

NCT00152555 | Terminated

• 1 other identifier: 13238B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if there is an improvement in patient's quality of life, pain, and fatigue after undergoing a supervised exercise program. If improvement is found, this will help guide standard of care with lupus patients with a focus on exercise for improvement of endurance, pain and overall health.

Conditions

Lupus Erythematosus, Systemic; SLE

Keywords

SLE,; exercize,; physical therapy,; Systemic lupus erythematosus; relaxation therapy

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is to assess quality of life with the SF-36 Physical Function Domain.

Secondary Outcomes (1)

• Pain, fatigue and depression assessed with the Pain Visual analogue scale, Fatigue Severity Score (FSS), Patient Global Assessment and BECK depression scale.

Interventions

Physical Therapy or Relaxation Therapy BEHAVIORAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SLE by ACR criteria; Age 16+ -

You may not qualify if:

• patients with an active lupus flare, or patients with physical limitations impairing their ability to participate in physical therapy. Other groups that will be excluded are those with limiting pulmonary disease and coronary artery disease. Patients with mechanical or structural abnormalities that would prohibit exercise (i.e. avascular necrosis of a weight-bearing joint) will also be excluded. Finally, patients already participating in a regular exercise program (\>1 day per week), or those with other conditions (based on the physicians discretion) which prohibit participating in physical therapy will not qualify for this study.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Physical Therapy Modalities; Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tammy Utset, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: March 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: June 12, 2013

Record last verified: 2007-04

Locations

US (1)