Physical Therapy for Systemic Lupus Erythematosus (SLE)
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|ClinicalTrials.gov Identifier: NCT00152555|
Recruitment Status : Terminated (study completed)
First Posted : September 9, 2005
Last Update Posted : June 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic SLE||Behavioral: Physical Therapy or Relaxation Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physical Therapy for Improvement of Quality of Life in Patients With Systemic Lupus Erythematosus (SLE)|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- The primary outcome measure is to assess quality of life with the SF-36 Physical Function Domain.
- Pain, fatigue and depression assessed with the Pain Visual analogue scale, Fatigue Severity Score (FSS), Patient Global Assessment and BECK depression scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152555
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Tammy Utset, MD||University of Chicago|