Lupus Erythematosus, Systemic Clinical Trial
Official title:
Physical Therapy for Improvement of Quality of Life in Patients With Systemic Lupus Erythematosus (SLE)
Verified date | April 2007 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 100 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: Diagnosis of SLE by ACR criteria; Age 16+ - Exclusion Criteria: 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is to assess quality of life with the SF-36 Physical Function Domain. | |||
Secondary | Pain, fatigue and depression assessed with the Pain Visual analogue scale, Fatigue Severity Score (FSS), Patient Global Assessment and BECK depression scale. |
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