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Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus

Exercise and Muscle Biology in Systemic Lupus Erythematosus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Skeletal muscle mitochondrial function will be assessed noninvasively using phosphorus-31 magnetic resonance spectroscopy."
  • "Magnetic resonance imaging of the thigh will be used to quantify intermuscular adipose tissue and muscle composition."
  • "Participants will also complete questionnaires assessing fatigue, fatigability, mobility, overall health, cognitive function, and SLE-related quality of life."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 16-week home exercise program can improve muscle health, daily movement, and tiredness in adults with stable lupus and ongoing tiredness. Lupus is a disease in which the body's defense system attacks healthy tissue. The program includes three exercise sessions each week, tailored to each person's needs, with some sessions guided by video.

Systemic lupus erythematosus, or SLE, is a chronic autoimmune disease that can cause persistent fatigue, muscle pain, reduced physical function, and impaired quality of life, even when the disease is otherwise clinically stable. The biological mechanisms contributing to these symptoms are not fully understood. Abnormal energy production within skeletal muscle and increased fat accumulation within the muscle may contribute to fatigue and reduced physical performance in people with SLE. This pilot study will evaluate the effects of a 16-week personalized, home-based exercise program in 20 adults with stable SLE and clinically significant fatigue. The program will include three exercise sessions per week: bodyweight high-intensity interval training, strength training, and walking-based interval training. Sessions will be adapted to each participant's fitness, mobility, symptoms, and exercise tolerance. Some sessions will be supervised remotely by video, while others will be completed independently using personalized recorded instructions. Participants will undergo assessments before and after the 16-week program. These assessments will examine skeletal muscle mitochondrial function, fat accumulation within the thigh muscles, physical performance, fatigue, quality of life, and blood-based markers of mitochondrial function and inflammation. The study will help determine whether a personalized home-based exercise program can improve muscle health and physical function in people with SLE and will provide information needed to design larger future studies.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 65, with lupus diagnosed using the study's required medical guidelines.
  • Stable lupus that does not threaten organs, with a disease activity score of 6 or less and no active kidney, brain, or spinal cord involvement.
  • No new disease-modifying or biologic lupus drug, and no dose change in drugs that lower immune activity, within 8 weeks before joining.
  • Ongoing tiredness and/or muscle pain, with a score of 55 or higher on the study's tiredness survey.
  • A steady prednisone dose of 5 mg a day or less, or an equal dose of a similar steroid, for at least 12 weeks before joining.
  • Able to safely do moderate exercise.
  • Able and willing to give informed consent, meaning you understand the study and agree to join.
  • Able and willing to follow the home exercise plan and complete study tasks.

Who can't join

  • Prednisone above 5 mg a day, a short course of higher-dose steroids within 8 weeks, or a lupus disease activity score above 8.
  • Pregnancy; severe anemia, meaning low red blood cells with hemoglobin below 10 g/dL; uncontrolled low thyroid activity; or uncontrolled diabetes.
  • Kidney failure needing dialysis or other kidney replacement treatment, or a kidney filtering rate below 30; blood pressure above 160/100; worsening heart failure; or unstable lung disease.
  • A brain or nerve condition that limits exercise, or severe joint wear and tear that makes exercise unsafe.
  • Another overlapping autoimmune disease, such as inflammatory muscle disease, mixed connective tissue disease, or systemic sclerosis; or a past organ or bone marrow transplant.
  • Any reason an MRI scan would be unsafe, or inability to fit safely on the scanner bed.
  • A heart attack or stroke-related event within 3 months; serious bleeding, including brain bleeding, within 12 months; or an acute infection within 1 month before joining.
  • Unable to give informed consent or follow the home exercise plan, or currently taking part in a structured exercise program.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 to 65 years. * Diagnosis of systemic lupus erythematosus according to the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology classification criteria. * Stable, non-organ-threatening systemic lupus erythematosus, defined as a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 6 or less at screening, with no active renal or central nervous system involvement. * Stable background lupus therapy, defined as no initiation of a new disease-modifying antirheumatic drug or biologic therapy and no change in the dose of immunosuppressive therapy within 8 weeks before enrollment. * Persistent fatigue and/or muscle pain, with a PROMIS Fatigue T-score of 55 or greater. * Stable prednisone dose, or equivalent glucocorticoid dose, of 5 mg per day or less for at least 12 weeks before enrollment. * Able to safely participate in a moderate-intensity exercise program. * Able and willing to provide informed consent. * Able and willing to comply with the home-based exercise protocol and study procedures. Exclusion Criteria: * Prednisone dose greater than 5 mg per day, or receipt of a glucocorticoid burst within 8 weeks before enrollment. * Pregnancy. * Severe anemia, defined as hemoglobin less than 10 g/dL. * Uncontrolled hypothyroidism. * Severe systemic lupus erythematosus disease activity, defined as a SLEDAI-2K score greater than 8. * End-stage kidney disease requiring renal replacement therapy or estimated glomerular filtration rate less than 30 mL/min/1.73 m². * Uncontrolled hypertension, defined as blood pressure greater than 160/100 mmHg. * Decompensated heart failure. * Unstable pulmonary disease. * Neurologic condition that limits exercise performance. * Uncontrolled diabetes mellitus. * Severe osteoarthritis that limits safe participation in the exercise intervention. * Overlap autoimmune disease, including inflammatory myopathy, mixed connective tissue disease, or systemic sclerosis. * History of solid-organ or bone marrow transplantation. * Any contraindication to magnetic resonance imaging. * Inability to fit safely on the magnetic resonance imaging scanner bed. * Myocardial infarction or cerebrovascular event within the previous 3 months. * Serious hemorrhage, including cerebral hemorrhage, within the previous 12 months. * Acute infectious illness within 1 month before enrollment. * Inability to provide informed consent. * Inability to adhere to the home-based exercise protocol. * Current participation in a structured exercise program.

Study sites (1)

AL