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This parallel-group randomized, controlled, clinical trial aims to investigate the influence of a 6-month home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.
Glucocorticoid treatment is a frequently prescribed to individuals with autoimmune diseases, such as Systemic Lupus Erythematosus, due to its anti-inflammatory effects. This treatment strategy has proven clinical benefits, but it can also adversely influence musculoskeletal health. Glucocorticoid pulse therapy is a particularly intensive treatment strategy, commonly used when the disease state is at its most active. Patients who undergo pulse therapy have a high risk of muscle and bone loss, and exercise training is a promising adjunct therapy to potentially ameliorate these adverse effects, but the feasibility and efficacy of this approach has yet to be investigated. The aim of this study, therefore, is to conduct a parallel-group, controlled, randomized clinical trial, to investigate the feasibility and efficacy of a home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | The experimental arm will enroll in a 6-month, twice-weekly, home-based, remotely monitored exercise training program, the emphasis of which will be to improve musculoskeletal health and function. |
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| Control | No Intervention | The control group will receive standard medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other | The present intervention will consist of a 6-month long, twice-weekly, home-based, monitored exercise training program, with training sessions lasting around 40 minutes, with 48 sessions in total. The program will be delivered in the form of 6 x 4-week "blocks", which will progressively increase in intensity and complexity, as the participants physical capacities develop. Additionally, and in addition with current physical activity guidelines, participants will be instructed to perform at least an additional 70 minutes of purposeful activities per week. Study trainers will discuss the content of these activities with each individual participant to facilitate selection of suitable activities (e.g., brisk walking, jogging, stair climbing or bike riding), but their selection will be left to the discretion of the individual participants, and activity logs will be maintained throughout the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone health | Assessed by dual-energy X-ray absorptiometry, high resolution peripheral quantitative computed tomography and blood bone biomarkers (C-terminal telopeptide [β-CTX-1], procollagen type 1 amino-terminal propeptide [P1NP], sclerostin, osteocalcin). | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle health | Assessed by dual-energy X-ray absorptiometry (fat-free mass), one-repetition maximum test (bench press and leg extension), and muscle functionality tests (timed-up-and-go, timed-stands, handgrip). | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Aerobic capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Gualano, PhD | Contact | 551126618022 | gualano@usp.br | |
| Eimear Dolan, PhD | Contact | +447934771844 | eimeardolan@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Eimear Dolan, PhD | Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of the School of Medicine, University of Sao Paulo | Recruiting | São Paulo | 05403-000 | Brazil |
On study completion, and once data has been analysed and submitted for publication, anonymised individual participant data for all outcomes will be made available.
Anonymised data will be made permanently available upon study completion and once data has been analysed and submitted for publication.
Anonymised data will be accessible to anyone interested via online repositories.
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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This study comprises a 6-month parallel-group, randomized, controlled trial, in which individuals with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy (500-1000mg/d methylprednisolone i.v., 1-3 days), will be randomized into one of two conditions: control, consisting of no intervention and standard medical care; and exercise training, consisting of standard medical care supplemented by a twice-weekly, home-based, remotely monitored exercise training program. Patients will be assessed at three timepoints, namely 1-3 weeks after pulse therapy (according to patient's health state and willingness, PRE); three months after baseline (MID); and six months after baseline (POST).
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Given that this is an exercise trial, blinding of study participants or investigators is not possible. Whenever possible, outcome assessors (e.g., lab technicians) will be blinded to the participants allocation.
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Assessed by maximal graded ergospirometric test. |
| Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Body composition | Assessed by dual-energy X-ray absorptiometry (fat mass, percentage body fat, lean mass), body mass index, waist and hip circumferences. | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Intervention feasibility and acceptability | Assessed by feasibility metrics: Recruitment Capacity, Acceptability and Suitability, Resources, and Intervention Efficacy. | Entire study duration. |
| Cardiovascular risk | Assessed by Framingham Risk Score | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Proinflammatory cytokines | Assessed by interferon gamma (IFN-γ), interleukin 10 and 6 (IL-10, IL-6), tumor necrosis factor alpha (TNF-α), and soluble TNF receptors (sTNFR1 e sTNFR2) assays. | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Nutritional intake | Assessed by three non-consecutive food recalls. | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Disease activity | Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| General quality of life | 36-Item Short Form Survey (SF-36). | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Disease-related quality of life | Assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQOL) | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Physical activity levels | Assessed by International Physical Activity Questionnaire (IPAQ) | Baseline (PRE), after 3 months (MID), and after 6 months (POST). |
| Current and past bone-loading physical activity levels | Assessed by Bone-Specific Physical Activity Questionnaire (BPAQ). | Baseline (PRE). |
| D001519 | Behavior |