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

NCT07716462 | Not Yet Recruiting

• 2 other identifiers: IRB-3000161322026MCA-1496
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erthematosus; Fatigue; Exercise Training

Keywords

SLE; Fatigue; Exercise

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Phosphocreatine Recovery Half-Time at 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.

  Baseline and Week 16

• Change From Baseline in Thigh Intermuscular Adipose Tissue at 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.

  Baseline and Week 16

Study Arms (1)

Personalized Home-Based HIIT

EXPERIMENTAL

Participants will complete a 16-week personalized, home-based exercise program consisting of three sessions per week: one bodyweight high-intensity interval training session, one strength-training session, and one walking-based high-intensity interval training session. The program will be tailored to each participant's physical fitness, mobility, symptoms, and exercise tolerance. Sessions will alternate between remotely video-supervised and self-directed personalized sessions. Heart rate, perceived exertion, adherence, and safety will be monitored throughout the intervention.

Behavioral: Personalized Home-Based High-Intensity Interval Training

Interventions

Personalized Home-Based High-Intensity Interval Training BEHAVIORAL

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.

Also known as: HB-HIIT

Personalized Home-Based HIIT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Lupus Research Alliance: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Frade S, O'Neill S, Greene D, Nutter E, Cameron M. Exercise as adjunctive therapy for systemic lupus erythematosus. Cochrane Database Syst Rev. 2023 Apr 19;4(4):CD014816. doi: 10.1002/14651858.CD014816.pub2.

  PMID: 37073886 BACKGROUND

• Blaess J, Geneton S, Goepfert T, Appenzeller S, Bordier G, Davergne T, Fuentes Y, Haglo H, Hambly K, Kinnett-Hopkins D, Su KY, Legge A, Li L, Mak A, Padjen I, Sciascia S, Sheikh SZ, Soriano-Maldonado A, Ugarte-Gil MF, Md Yusof MY, Parodis I, Arnaud L. Recommendations for physical activity and exercise in persons living with Systemic Lupus Erythematosus (SLE): consensus by an international task force. RMD Open. 2024 Apr 4;10(2):e004171. doi: 10.1136/rmdopen-2024-004171.

  PMID: 38580348 BACKGROUND

MeSH Terms

Conditions

Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jose E Rubio, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose E Rubio, MD

CONTACT

205-574-9351; JERUBIOMOSQUERA@UABMC.EDU

Vivian Kawai, MD MPH

CONTACT

vkkawai@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-arm, before-and-after pilot study. All enrolled participants will receive the same 16-week personalized, home-based, video-supervised high-intensity interval training program. Study outcomes will be assessed at baseline and after completion of the intervention. There is no comparator or control arm.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after publication of the primary study results and no later than the end of the funded project period, consistent with the approved data-sharing plan. Data may remain available for at least 5 years after initial release, subject to institutional and repository requirements.
• Access Criteria: Qualified researchers may submit a written request describing the scientific purpose, requested data, proposed analyses, data-security measures, and plans for publication. Requests will be evaluated for scientific merit, participant privacy, consistency with informed consent, and compliance with institutional and funding-agency requirements. An approved data use agreement may be required before access is granted.

Locations

US (1)