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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186794
Recruitment Status : Terminated (Research activities were suspended due to the COVID-19 pandemic)
First Posted : June 14, 2017
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
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
Actual Primary Completion Date : February 25, 2021
Actual Study Completion Date : February 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic exercise training (AET)
Participants with systemic lupus erythematosus participated in a 12-week aerobic exercise training program. Exercise was performed on a treadmill, three times a week for 30 minutes at target training intensity of 70 - 80% of heart rate reserve [0.7 to 0.8 * (peak heart rate - resting heart rate) + resting heart rate]
Other: Treadmill exercise training
30 minutes of continuous treadmill walking at a target intensity or use of an interval approach 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 session will last about 60 minutes but slightly longer if an interval approach is used.




Primary Outcome Measures :
  1. Change in the Time Taken to Attain the Anaerobic Threshold (AT) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The anaerobic threshold (AT) is an objective measure of fatigability, and is determined from gas exchange variables during a cardiopulmonary exercise test (CPET). The effect of exercise training was examined by the change in the time taken to attain the AT by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in fatigability and a negative value indicates no improvement or worsening in fatigability. CPET measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  2. Change in the Time Constant for Oxygen Uptake Kinetics [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The oxygen uptake kinetics is an objective measure of fatigability, determined from oxygen uptake measures during a square-wave exercise test. The time constant is the time taken to reach 63% of the steady state response. The effect of exercise training was examined by the change in the time constant by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The square-wave exercise test was done before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  3. Change in Performance Fatigability Index (PerfFI) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The performance fatigability index (PerfFI) is a measure of fatigability. The PerfFI was determined during a 10-minute walk test (10MWT). The average velocity of 10MWT was divided by the average velocity achieved over the first 2.5 minutes (decline in performance), then further divided by the total distance walked on the 10MWT (an index of intensity) multiplied by 1000. The effect of exercise training was examined by the change in the PerfFI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The 10MWT measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  4. Change in Perceived Fatigability Index (PercFI) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The perceived fatigability index (PercFI) is a measure of fatigability. The PercFI was determined during a 10-minute walk test (10MWT) by rating their perceive tiredness on a 7-point Likert scale after the test. The score is divided by the total distance walked on the 10MWT, multiplied by 1000. The effect of exercise training was examined by the change in the PerfFI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigability and a positive value indicates no improvement or worsening in fatigability. The 10MWT measurement was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).


Secondary Outcome Measures :
  1. Change in Muscle Oxygenation [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    Muscle oxygenation is indicated by tissue saturation index (TSI), which is the amount of oxygenated hemoglobin divided by total hemoglobin in percent. This is evaluated using near-infrared spectroscopy (NIRS) during the cardiopulmonary exercise test (CPET). Peak TSI is determined at the end of the CPET representing the lowest muscle oxygenation during volitional exercise. The effect of exercise training was examined by the change in peak TSI by measuring the post-exercise training value minus the pre-exercise training value. A negative value may indicate better muscle oxygenation capacity and a positive value may indicate no change or reduction in muscle oxygenation capacity. The CPET was performed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  2. Change in Cardiac Function [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    Cardiac function is indicated by cardiac output, which is the amount of blood the heart pumps in 1 minute. It is defined mathematically as the product of the heart rate and cardiac stroke volume. This is measured using bioimpedance cardiography (a non-invasive method of capturing cardiodynamic variables) during the cardiopulmonary exercise test (CPET). Peak cardiac output is determined at the end of the CPET representing the highest cardiac output during volitional exercise. The effect of exercise training was examined by the change in peak cardiac output by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in cardiac function and a negative value indicates no change or worsening in cardiac function. The CPET was performed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  3. Change in Fatigue Severity Scale (FSS) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The Fatigue Severity Scale (FSS) is a 9-item questionnaire that assesses fatigue severity on a 7-point Likert scale. The FSS score is an average of the total score for the 9-items, with a minimum of 1 and a maximum of 7. A higher FSS score indicate more fatigue severity. The effect of exercise training was examined by the change in FSS average scores by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigue severity and a positive value indicates no improvement or worsening in fatigue severity. The FSS questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  4. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Anxiety Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The anxiety domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more anxiety being measured. The effect of exercise training was examined by the change in anxiety domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in anxiety and a positive value indicates no improvement or worsening in anxiety. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  5. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Depression Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The depression domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more depression being measured. The effect of exercise training was examined by the change in depression domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in depression and a positive value indicates no improvement or worsening in depression. The PROMIS-57 profile was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  6. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Fatigue Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate greater fatigue. The effect of exercise training was examined by the change in fatigue domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in fatigue and a positive value indicates no improvement or worsening in fatigue. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  7. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Physical Function Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The Physical Function domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more physical function being measured. The effect of exercise training was examined by the change in physical function domain by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in physical function and a negative value indicates no improvement or worsening in physical function. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  8. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Sleep Disturbance Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The Sleep Disturbance domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more sleep disturbance being measured. The effect of exercise training was examined by the change in sleep disturbance domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in sleep disturbance and a positive value indicates no improvement or worsening in sleep disturbance. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  9. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Ability to Participate in Social Roles and Activities Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The ability to participate in social roles and activities domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more ability to participate in social roles and activities. The effect of exercise training was examined by the change in ability to participate in social roles and activities domain by measuring the post-exercise training value minus the pre-exercise training value. A positive value indicates improvement in ability to participate in social roles and activities and a negative value indicates no improvement or worsening in ability to participate in social roles and activities. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  10. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Pain Interference Domain [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. The pain interference domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more pain interference being measured. The effect of exercise training was examined by the change in pain interference domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in pain interference and a positive value indicates no improvement or worsening in pain interference. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  11. Change in Patient Reported Outcomes Measurement Information System (PROMIS-57 Profile): Pain Intensity Score [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    The PROMIS-57 profile is a self-reported questionnaire assessing quality of life in various domains. Pain intensity is scored from 0 to 10, with higher scores indicating greater pain intensity. The effect of exercise training was examined by the change in pain intensity domain by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in pain intensity and a positive value indicates no improvement or worsening in pain intensity. The PROMIS-57 profile questionnaire was done once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  12. Change in Safety of Estrogen in Lupus Erythematosus, National Assessment Modification of Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    SELENA-SLEDAI is a 24-item weighted index measure of disease activity at time of assessment or in the preceding 10 days. It consists of clinical and laboratory variables, with a minimum score of 0 and maximum score of 105. Higher scores represent greater disease activity. The effect of exercise training was examined by the change in SELENA-SLEDAI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates improvement in disease activity and a positive value indicates no improvement or worsening in disease activity. The SELENA-SLEDAI was assessed once before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).

  13. Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR-DI) [ Time Frame: Before 12-week intervention (Pre) and after 12-week intervention (Post) ]
    SLICC/ACR-DI is a 41-item instrument used to assess damage since lupus disease onset. Clinical assessment is made in 12 different organ systems, and a sum total from all organ scales are computed. A minimum score of 0 and a maximum score of 47 is possible with higher scores indicating more damage. The effect of exercise training was examined by the change in SLICC/ACR-DI by measuring the post-exercise training value minus the pre-exercise training value. A negative value indicates no change in damage since disease onset and a positive value indicates increase in damage since disease onset. The SLICC/ACR-DI was assessed before the start of the 12-week exercise program (pre) and repeated at the end of the 12-week exercise program (post).



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.


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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.
  • Fatigue Severity Scale (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 American College of Rheumatology (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


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)
  Study Documents (Full-Text)

Documents provided by National Institutes of Health Clinical Center (CC):
Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03186794    
Other Study ID Numbers: 170111
17-CC-0111
First Posted: June 14, 2017    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Limited, de-identified samples may be available to other NIH intramural researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication of results.
Access Criteria: Permission of PI and approval from the IRB prior to any research use of stored de-identified samples beyond the scope of this study.

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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:
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Rheumatic Diseases
Lupus Erythematosus, Systemic
Collagen Diseases
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Musculoskeletal Diseases