Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152555
Status:
TERMINATED
Last Update Posted:
2013-06-12
First Post:
2005-09-08
Brief Title:
Physical Therapy for Systemic Lupus Erythematosus SLE
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Physical Therapy for Improvement of Quality of Life in Patients With Systemic Lupus Erythematosus SLE
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if there is an improvement in patients 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 patients 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 patients 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 heshe stops attending PT sessions on their own
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 patients 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 heshe stops attending PT sessions on their own
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None