Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07716462

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

Official title: Exercise and Muscle Biology in Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2027-12

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Systemic Lupus Erthematosus Fatigue Exercise Training

Interventions

BEHAVIORAL

Personalized Home-Based High-Intensity Interval Training

Participants will complete a 16-week personalized, home-based, moderate- to high-intensity exercise program. The program includes three sessions per week: bodyweight high-intensity interval training, strength training using bodyweight, light weights, or resistance bands, and walking-based high-intensity interval training. Exercise intensity and duration will progress gradually and will be individualized according to baseline fitness, mobility, disease manifestations, pain, and exercise tolerance. Video-supervised sessions with an exercise trainer will alternate with self-directed sessions using personalized prerecorded videos. Participants will use a heart-rate monitor during exercise and will record perceived exertion. The study team will monitor adherence and safety and will conduct regular telephone or text check-ins. Exercise intensity and activities may be modified during increased joint symptoms or an SLE flare.

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States