NCT07716462Not yet recruiting
Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus
Exercise and Muscle Biology in Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- Dec 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Lupus (SLE)
- NCT number
- NCT07716462
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Dec 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prednisone dose greater than 5 mg per day, or receipt of a glucocorticoid burst within 8 weeks before enrollment.
- 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.
Other illness
- 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.
- Overlap autoimmune disease, including inflammatory myopathy, mixed connective tissue disease, or systemic sclerosis.
- History of solid-organ or bone marrow transplantation.
Lab values
- Severe anemia, defined as hemoglobin less than 10 g/dL.
Other
- Pregnancy.
- Uncontrolled hypothyroidism.
- Severe osteoarthritis that limits safe participation in the exercise intervention.
- Any contraindication to magnetic resonance imaging.
- Inability to fit safely on the magnetic resonance imaging scanner bed.
- Inability to provide informed consent.
- Inability to adhere to the home-based exercise protocol.
- Current participation in a structured exercise program.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Kirklin Clinic of UAB Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.