Home workouts may rev up muscle energy in lupus patients

NCT ID NCT07716462

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This trial is taking on new participants right now.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether a 16-week personalized home exercise program can improve muscle health and reduce fatigue in adults with stable lupus. Participants do three weekly sessions combining high-intensity interval training, strength exercises, and walking. Researchers measure changes in muscle energy production, fat within muscles, physical performance, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a personalized home-based high-intensity interval training program
What this could lead to
If successful, this approach could offer a safe, accessible way to reduce fatigue and improve physical function in people with lupus.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply broadly. The exercise program may be too demanding for some individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Fatigue Motor Activity systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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