Aerobic Exercise in Women With Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT03186794|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : May 17, 2019
As many as 1.5 million Americans are living with systemic lupus erythematosus (Lupus). Lupus makes people very tired. It also makes it hard for people to be physically active. Studies have shown that aerobic exercise training helps people with heart or lung illnesses be less tired and more active. Researchers want to use an exercise training program on people with Lupus to see if it has the same results.
To find out if aerobic exercise helps people with Lupus be less tired and more active.
Women ages 21-80 who have Lupus and are not physically active.
Participants will be screened with a medical history and physical exam. They will have heart and lung tests, as well as blood and urine tests. They will also answer questions about their quality of life and take a test that measures lupus activity.
The study will last 14-16 weeks.
For the first two study visits, participants will do treadmill exercise tests and answer more quality of life questions. For these treadmill tests, participants will wear sensors, a mask, or a mouthpiece while they exercise.
Participants will then begin exercise training, 3 times a week for 12 weeks. At each of these visits, they will walk very fast for 30 minutes on a track or a treadmill. Each visit will last about 1 hour.
At the halfway point of the study, participants will repeat some of the screening tests. This visit will last about 3 hours.
At the end of the study, participants will repeat the screening tests. They will also repeat the treadmill exercise tests.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Lupus Autoimmune Disease Rheumatic Disease||Other: Treadmill exercise training||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study Characterizing Aerobic Exercise in Women With Systemic Lupus Erythematosus (Exercise SLE Pilot)|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: SLE Exercise
We propose to enroll 20 sedentary, adult, women with negligible to mild SLE disease activity (SELENA-SLEDAI less than or equal to 4) in this pilot study. Subjects must also have a Fatigue Severity Scale (FSS) composite score less than or equal to 4.0. We will restrict our recruitment to women with SLE as this is a small pilot study and would like to eliminate possible gender-biased confounders of physical activity (approximately 90% of patients with SLE are women).
Other: Treadmill exercise training
The target training heart rate range is 70-80% of heart rate reserve, computed as: 0.7 and 0.85 (peak heart rate minus resting heart rate) + resting heart rate. Subjects will exercise for 30 minutes per session, completing on average 3 sessions per week, over approximately 12 weeks. During the training session, heart rate, treadmill speed, treadmill inclination, perceived fatigability index and RPE will be recorded. In the event that subjects cannot sustain 30 minutes of continuous treadmill walking at the target intensity, an interval approach will be used in which walking at the target will be sustained at smaller training interval durations of no shorter than 5 minutes followed by an active rest interval that is no longer than 1.5 times the training interval until the subject achieves a total exercise time of 30 minutes, excluding the rest intervals. Each of these sessions will last about 60 minutes but slightly longer if an interval approached is used.
- The primary outcome measure for our trial will be the time taken to attain the anaerobic threshold, which is a performance marker of fatigability that is unaffected by patient motivation or perception. [ Time Frame: Pre to post exercise training (12 weeks) ]Anaerobic threshold is an objective measure of fatigability. The V-slope method is used to visually determine the first point of departure from linearity of carbon dioxide output (VC02) plotted against oxygen uptake (V02).
- Exercise training induced changes in muscle oxygenation and cardiac function and changes in questionnaire responses. [ Time Frame: Pre to post exercise training (12 weeks) ]
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): NCT03186794
|Contact: Lisa M Chin, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|