Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aerobic Exercise in Women With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03186794
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

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.

Objectives:

To find out if aerobic exercise helps people with Lupus be less tired and more active.

Eligibility:

Women ages 21-80 who have Lupus and are not physically active.

Design:

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Exercise training induced changes in muscle oxygenation and cardiac function and changes in questionnaire responses. [ Time Frame: Pre to post exercise training (12 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Fulfilling 4 of the 11 American College of Rheumatology Criteria for the Classification of Systemic Lupus Erythematosus
  • Age 21 to 80
  • Female Gender
  • BMI less than 40
  • No primary or secondary medical conditions that would limit aerobic capacity or make exercise participation unsafe. These conditions are found under the exclusion criteria listed below and include cardiovascular disease and cardiomyopathy, pulmonary and pulmonary vascular disease, stroke, significant hepatic or renal dysfunction, most cancers, diabetes mellitus, HIV infection, and peripheral vascular disease.
  • SELENA-SLEDAI score less than or equal to 4, maintained for at least three months. (C3 and C4 levels are measured as markers for stability and included in the SELENA-SLEDAI score if abnormal).
  • No increase in doses of immunosuppressive medications (hydroxychloroquine, mycophenolate mofetil, azathioprine, methotrexate) for at least three months at the time of screening.
  • No increase in the dose of prednisone or equivalent steroid in the past 3 months at the time of screening.
  • Physically inactive, not participating in aerobic exercise training at heart rate above 60% maximum heart rate, 20 min/session or more, 2 or more days per week, within the last 6 months at the time of screening.
  • FSS composite score greater than or equal to 3 indicating the presence of clinically significant fatigue
  • Subjects must be able to walk on a treadmill

EXCLUSION CRITERIA:

  • Prednisone greater than or equal to 15 mg daily (or equivalent)
  • Have started azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide or biologics within 3 months
  • Rituximab infusion within 6 months
  • Present symptoms of ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non- idiopathic cardiomyopathy
  • Significant pulmonary dysfunction (obstructive, restrictive, or infectious pulmonary disease)
  • Significant hepatic(LFT > 2 times of upper limit of normal) or renal dysfunction (GFR<45 ml/min)
  • Deep vein thrombosis
  • Chronic anticoagulation (with the exception of low dose aspirin) or a history of a bleeding disorder
  • History or presence of any form of cancer other than skin cancer or cervical in-situ cancer
  • History of cerebrovascular accident
  • Orthopedic conditions that would limit performance of treadmill exercise tests or treadmill exercise training
  • Current smoker or active substance abuse
  • HIV infection
  • Any medication that limit exercise capacity or the ability to adapt to aerobic exercise training

    --(e.g. beta-blockers, anti-retroviral therapy for the treatment of HIV infection)

  • Diabetes Mellitus
  • Fibromyalgia: Determined at pre-screening visit, as per 2010 ACR criteria for diagnosis of fibromyalgia
  • Uncontrolled or untreated thyroid dysfunction: Determined by abnormal Thyroid Stimulating Hormone (TSH) level checked at the time of screening or within 3 months before screening visit.
  • Currently pregnant, nursing or plan to become pregnant during the duration of the study
  • Anemia (hemoglobin < 9 g/dl)
  • Significant peripheral vascular disease
  • Severe Raynaud s phenomenon
  • Individuals unable to give informed consent

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Lisa M Chin, Ph.D. (301) 443-9072 chinlm@mail.nih.gov

Locations
Layout table for location information
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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Layout table for investigator information
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03186794     History of Changes
Other Study ID Numbers: 170111
17-CC-0111
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 8, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC):
Rehabilitation
Fatigue

Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Autoimmune Diseases
Rheumatic Diseases
Collagen Diseases
Connective Tissue Diseases
Immune System Diseases
Musculoskeletal Diseases