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Home-Based Exercise for Lupus Fatigue

This study is looking at how a personalized, home-based exercise program called High-Intensity Interval Training (HIIT) might help adults with Systemic Lupus Erythematosus (SLE), also known as lupus. Many people with lupus experience ongoing tiredness (fatigue) and muscle pain, even when their lupus is stable. This 16-week program involves three exercise sessions per week, including bodyweight HIIT, strength training, and walking-based exercises. Researchers want to see if this program can improve muscle energy production and reduce fat within muscles, which may contribute to fatigue. You might be able to join if you are 18-65 years old, have a stable lupus diagnosis, and experience significant fatigue. The study aims to enroll 20 participants.

Study design
This is a pilot study involving 20 participants, where everyone receives the personalized home-based exercise program. It is not specified if participants or researchers will know who is receiving the intervention.
What's involved
You would participate in a 16-week personalized, home-based exercise program with three sessions per week. Measurements will be taken at the beginning and at week 16.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes up to week 16, which is the end of the intervention period.

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NCT07716462

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

Not Yet Recruiting
NAAges 18–65InterventionalBasic science
University of Alabama at Birmingham
~20 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Personalized Home-Based High-Intensity Interval Training

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Phosphocreatine Recovery Half-Time at Week 16
Measured over Baseline and Week 16
+1 more outcome measured

Conditions

Systemic Lupus Erthematosus
Fatigue
Exercise Training

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Jose E Rubio, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Jose E Rubio, MD
[email protected]
205-574-9351
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change From Baseline in Phosphocreatine Recovery Half-Time at Week 16Baseline and Week 16

    Skeletal muscle mitochondrial oxidative capacity will be assessed using phosphorus-31 magnetic resonance spectroscopy (31P-MRS) of the thigh. Following a standardized knee-extension exercise, the phosphocreatine recovery half-time will be calculated in seconds. The recovery half-time is the time required to restore one-half of the phosphocreatine depleted during exercise. A shorter recovery half-time indicates faster recovery and greater skeletal muscle mitochondrial oxidative capacity.

  • Change From Baseline in Thigh Intermuscular Adipose Tissue at Week 16Baseline and Week 16

    Intermuscular adipose tissue will be quantified from magnetic resonance imaging of the thigh. Intermuscular adipose tissue will be expressed as the percentage of adipose tissue located within the muscle compartment relative to the total muscle compartment. A lower percentage indicates less intermuscular adipose tissue accumulation.