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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07716462
Status
Not Yet Recruiting

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Conditions

  • Exercise Training
  • Fatigue
  • Systemic Lupus Erthematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Personalized Home-Based HIIT
    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.

Primary Outcome Measure

Change From Baseline in Phosphocreatine Recovery Half-Time at Week 16 [ Time Frame: Baseline and Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
JOSE E RUBIO MOSQUERA, MD
[email protected]
2055749351
JOSE E RUBIO, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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