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Physical Therapy for Systemic Lupus Erythematosus (SLE)

Primary Purpose

Lupus Erythematosus, Systemic, SLE

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy or Relaxation Therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring SLE,, exercize,, physical therapy,, Systemic lupus erythematosus, relaxation therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
June 11, 2013
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00152555
Brief Title
Physical Therapy for Systemic Lupus Erythematosus (SLE)
Official Title
Physical Therapy for Improvement of Quality of Life in Patients With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
study completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

5. Study Description

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.
Detailed Description
After patients have been selected and consented for this study, they will fill out a series of questionnaires. These surveys are used to stratify the patient's disease activity, assess perception of disease limitations including quality of life, fatigue and pain. We intend to use the Systemic Lupus Disease Activity Index (SLEDAI) to quantify disease activity and the SLICC to characterize the study population. Pain, fatigue and depression will be assessed with the Pain Visual analogue scale, Fatigue Severity Score (FSS), Patient Global Assessment and BECK depression scale. Other initial data to be collected include patient's prednisone dose and resting heart rate. No specific laboratory data will be collected for this study. Patients will continue with standard of care monitoring based on their disease activity and medications. The 100 patients will be randomized approximately 50 in the exercise group and 50 in the relaxation therapy group. The relaxation group will serve as the control arm of the study. The patients in the relaxation therapy group will then undergo a training session on biofeedback as well as receive further materials on relaxation techniques and a relaxation tape. The relaxation tape will request subjects to systematically contract and relax eleven isolated muscle groups. These muscle groups include; hands and wrists, biceps and triceps, shoulders alone, neck, tongue and mouth, eyes, nose and forehead, back alone, abdominal area alone, thighs alone, calves and feet and finally toes alone. This group of subjects will be asked to perform relaxation exercises at home a minimum of three times a week. The subjects in the exercise group will have visits about 2 times per week for a total of 8 weeks, for a total of 16 visits. The first visit will include a general evaluation (strength, range of motion, standing balance, gait assessment, baseline vitals), determination of heart rate range for exercise and explanation of exercise portion of the study and home exercise program. Visits 2 through 16 you will participate in simple, supervised exercise at the physical therapy center at the University of Chicago. Heart rates will be measured several times throughout your exercise visits. Additionally, subjects will be asked to rate your level of pain, your blood pressure will be taken before and after and you will be advised regarding at home exercises. Each subject will be seen for 16 visits total, unless a he/she stops attending PT sessions on their own.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, SLE
Keywords
SLE,, exercize,, physical therapy,, Systemic lupus erythematosus, relaxation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy or Relaxation Therapy
Primary Outcome Measure Information:
Title
The primary outcome measure is to assess quality of life with the SF-36 Physical Function Domain.
Secondary Outcome Measure Information:
Title
Pain, fatigue and depression assessed with the Pain Visual analogue scale, Fatigue Severity Score (FSS), Patient Global Assessment and BECK depression scale.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Utset, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Physical Therapy for Systemic Lupus Erythematosus (SLE)

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