Systemic Lupus ErythematosusNCT05090189
Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
A study testing Exercise Training in people with Systemic Lupus Erythematosus, run by Bruno Gualano at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Aug 2021to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women aged 18 to 45 diagnosed with Systemic Lupus Erythematosus according to SLICC criteria;
- Medical indication and prescription for glucocorticoid pulse therapy;
- Access to Internet and any device that allows for participation in exercise training online lessons (such as smart phone, laptop or personal computer);
- Willingness to participate in an exercise training program.
Who cannot join
- Any physical, mental, neurological or musculoskeletal health impairment that contra-indicates exercise training.
- Use of medical therapy that alters bone metabolism, such as bisphosphonates, teriparatide and denosumab;
- Receiving prescription for multiple glucocorticoid pulse therapies mid-intervention;
- Being currently enrolled or having enrolled in a structured exercise training program in the last 6 months (defined as at least 2 planned, structures sessions of exercise training per week);
- Having a vertebral fracture at the moment of enrollment (identified by Vertical Fracture Assessment), or high risk for fracture (defined as low hip or spine bone mass [z-score < -3] or history of fragility fractures).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital of the School of Medicine, University of Sao Paulo
São Paulo, 05403-000
Bruno Gualano, PhD, 551126618022, gualano@usp.br
Eimear Dolan, PhD, +447934771844, eimeardolan@usp.br
About this study
Official title: The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Exercise Training
- Keywords
- exercise, autoimmune, training, glucocorticoids
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Training |
| Control | No intervention | The control group will receive standard medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary outcomes (12)
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).
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Aerobic capacity
Assessed by maximal graded ergospirometric test.
Measured: 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.
Measured: 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.
Measured: Entire study duration.
Cardiovascular risk
Assessed by Framingham Risk Score
Measured: 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.
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Nutritional intake
Assessed by three non-consecutive food recalls.
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Disease activity
Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
General quality of life
36-Item Short Form Survey (SF-36).
Measured: 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)
Measured: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Physical activity levels
Assessed by International Physical Activity Questionnaire (IPAQ)
Measured: 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).
Measured: Baseline (PRE).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start27 Aug 2021
- Primary completionAug 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruno Gualano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Eimear Dolan, PhD, Principal investigator, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090189
- Sponsor's protocol ID
- The ENRG Study
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On study completion, and once data has been analysed and submitted for publication, anonymised individual participant data for all outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy
- ClinicalTrials.gov ID
- NCT05090189
- Acronym / sponsor ID
- The ENRG Study
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- exercise, autoimmune, training, glucocorticoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bruno GualanoUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise TrainingThe 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. |
| Control | No intervention | –The control group will receive standard medical care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal women aged 18 to 45 diagnosed with Systemic Lupus Erythematosus according to SLICC criteria;
- Medical indication and prescription for glucocorticoid pulse therapy;
- Access to Internet and any device that allows for participation in exercise training online lessons (such as smart phone, laptop or personal computer);
- Willingness to participate in an exercise training program.
Key exclusion criteria (5 listed)
- Any physical, mental, neurological or musculoskeletal health impairment that contra-indicates exercise training.
- Use of medical therapy that alters bone metabolism, such as bisphosphonates, teriparatide and denosumab;
- Receiving prescription for multiple glucocorticoid pulse therapies mid-intervention;
- Being currently enrolled or having enrolled in a structured exercise training program in the last 6 months (defined as at least 2 planned, structures sessions of exercise training per week);
- Having a vertebral fracture at the moment of enrollment (identified by Vertical Fracture Assessment), or high risk for fracture (defined as low hip or spine bone mass [z-score < -3] or history of fragility fractures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingThe 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. | Other | Exercise training |
Primary outcome
Bone health
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
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).
12 secondary outcomes
Muscle health
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Aerobic capacity
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Body composition
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Intervention feasibility and acceptability
Time frame: Entire study duration.
Cardiovascular risk
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Proinflammatory cytokines
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Nutritional intake
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Disease activity
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
General quality of life
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Disease-related quality of life
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Physical activity levels
Time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Current and past bone-loading physical activity levels
Time frame: Baseline (PRE).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Yes. On study completion, and once data has been analysed and submitted for publication, anonymised individual participant data for all outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eimear Dolan, PhD principal investigator
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Systemic Lupus Erythematosus, run by Bruno Gualano at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (551126618022, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone health (time frame: Baseline (PRE), after 3 months (MID), and after 6 months (POST).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.