Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus (MIGHT-SLE)
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jose E Rubio, MD
- 전화번호: 205-574-9351
- 이메일: JERUBIOMOSQUERA@UABMC.EDU
연구 연락처 백업
- 이름: Vivian Kawai, MD MPH
- 이메일: vkkawai@uab.edu
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
-
연락하다:
- JOSE E RUBIO MOSQUERA, MD
- 전화번호: 2055749351
- 이메일: JERUBIOMOSQUERA@UABMC.EDU
-
수석 연구원:
- JOSE E RUBIO, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Phosphocreatine Recovery Half-Time at Week 16
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jose E Rubio, MD, University of Alabama at Birmingham
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-300016132
- 2026MCA-1496 (기타 보조금/기금 번호: Lupus Research Alliance)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .