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Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus (MIGHT-SLE)

2026年7月16日 更新者：Jose E. Rubio Mosquera、University of Alabama at Birmingham

Exercise and Muscle Biology in Systemic Lupus Erythematosus

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a single-arm, pilot, proof-of-concept study evaluating the clinical and biological effects of a 16-week personalized, home-based high-intensity interval training program in 20 adults with stable systemic lupus erythematosus and persistent fatigue and/or muscle pain.

SLE-related fatigue is common and may persist despite adequate control of inflammatory disease activity. Skeletal muscle mitochondrial dysfunction may impair cellular energy production and contribute to fatigability and exercise intolerance. In addition, intermuscular adipose tissue, defined as fat located within the muscle compartment, is increased in some people with SLE and may be associated with systemic inflammation, fatigue, and reduced physical function.

The exercise intervention will include three sessions per week:

One bodyweight high-intensity interval training session One strength-training session One walking-based high-intensity interval training session

Exercise duration and intensity will increase gradually during the 16-week intervention. The program will be personalized according to each participant's baseline fitness, mobility, exercise preferences, SLE manifestations, pain, and exercise tolerance. Exercise sessions will alternate between remotely supervised video sessions and self-directed sessions using individualized prerecorded videos. Participants will use a heart-rate monitor during exercise, and the study team will conduct regular check-ins to support adherence and safety. Exercise intensity may be reduced or modified if a participant develops increased pain, joint symptoms, or an SLE flare.

Participants will complete study assessments at baseline and after the 16-week intervention. Skeletal muscle mitochondrial function will be assessed noninvasively using phosphorus-31 magnetic resonance spectroscopy. The primary measure of mitochondrial function will be phosphocreatine recovery following a brief standardized muscle exercise.

Magnetic resonance imaging of the thigh will be used to quantify intermuscular adipose tissue and muscle composition. Additional imaging may assess abdominal and liver fat.

Physical performance will be evaluated using the six-minute walk test and the 30-second sit-to-stand test. Participants will also complete questionnaires assessing fatigue, fatigability, mobility, overall health, cognitive function, and SLE-related quality of life.

Blood and other biological samples will be collected before and after the intervention. Laboratory analyses will evaluate circulating markers of mitochondrial function, inflammation, and inflammasome activation. Exploratory analyses may include gene expression, proteomic, genetic, urine, and microbiome studies for participants who provide the required consent.

The study will compare each participant's measurements before and after the exercise intervention. The primary outcomes will evaluate changes in skeletal muscle mitochondrial function and intermuscular adipose tissue. Secondary and exploratory analyses will evaluate changes in physical performance, fatigue, quality of life, inflammatory markers, and other biological measures.

Because this is a small, uncontrolled pilot study, it is intended to identify preliminary signals of biological and clinical benefit rather than establish definitive efficacy. Results will inform the feasibility, outcome selection, and sample-size planning of future controlled trials of personalized exercise interventions in SLE.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
        • 接触：
        • 首席研究员：
          • JOSE E RUBIO, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.

其他名称：
  • HB-HIIT

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Phosphocreatine Recovery Half-Time at Week 16
大体时间：Baseline and 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
大体时间：Baseline and 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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Alabama at Birmingham

合作者

Lupus Research Alliance

调查人员

  • 首席研究员：Jose E Rubio, MD、University of Alabama at Birmingham

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年7月16日

首先提交符合 QC 标准的

2026年7月16日

首次发布 (实际的)

2026年7月21日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-300016132
  • 2026MCA-1496 (其他赠款/资助编号：Lupus Research Alliance)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in publications from this study may be shared with qualified researchers. Shared data may include relevant clinical, patient-reported, physical performance, imaging-derived, and laboratory outcome data, together with the study protocol, statistical analysis plan, and data dictionary, as applicable.

Data sharing will be conducted in accordance with the final IRB-approved protocol, informed consent, Lupus Research Alliance Data Management and Sharing Plan, institutional policies, and applicable privacy regulations. Requests will be reviewed by the study investigators and the University of Alabama at Birmingham. Access may require an approved research proposal, institutional review, and execution of a data use agreement. Direct identifiers will not be shared.

IPD 共享时间框架

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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