Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Personalized Home-Based High-Intensity Interval Training
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Personalized Home-Based HIITExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Week 162
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.
Time frame
Baseline and Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Lupus Research Alliance
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: