Back to resultsExercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring exercise, autoimmune, training, glucocorticoids
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Clinical Hospital of the School of Medicine, University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise training
Control
Arm Description
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.
The control group will receive standard medical care.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Aerobic capacity
Assessed by maximal graded ergospirometric test.
Body composition
Assessed by dual-energy X-ray absorptiometry (fat mass, percentage body fat, lean mass), body mass index, waist and hip circumferences.
Intervention feasibility and acceptability
Assessed by feasibility metrics: Recruitment Capacity, Acceptability and Suitability, Resources, and Intervention Efficacy.
Cardiovascular risk
Assessed by Framingham Risk Score
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.
Nutritional intake
Assessed by three non-consecutive food recalls.
Disease activity
Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
General quality of life
36-Item Short Form Survey (SF-36).
Disease-related quality of life
Assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQOL)
Physical activity levels
Assessed by International Physical Activity Questionnaire (IPAQ)
Current and past bone-loading physical activity levels
Assessed by Bone-Specific Physical Activity Questionnaire (BPAQ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05090189
Brief Title
Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
Official Title
The Influence of Exercise Training on Musculoskeletal Health in Patients With Systemic Lupus Erythematosus Who Undergo Glucocorticoid Pulse Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruno Gualano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
exercise, autoimmune, training, glucocorticoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive standard medical care.
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone health
Description
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).
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Secondary Outcome Measure Information:
Title
Muscle health
Description
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).
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Aerobic capacity
Description
Assessed by maximal graded ergospirometric test.
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Body composition
Description
Assessed by dual-energy X-ray absorptiometry (fat mass, percentage body fat, lean mass), body mass index, waist and hip circumferences.
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Intervention feasibility and acceptability
Description
Assessed by feasibility metrics: Recruitment Capacity, Acceptability and Suitability, Resources, and Intervention Efficacy.
Time Frame
Entire study duration.
Title
Cardiovascular risk
Description
Assessed by Framingham Risk Score
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Proinflammatory cytokines
Description
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.
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Nutritional intake
Description
Assessed by three non-consecutive food recalls.
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Disease activity
Description
Assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
General quality of life
Description
36-Item Short Form Survey (SF-36).
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Disease-related quality of life
Description
Assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQOL)
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Physical activity levels
Description
Assessed by International Physical Activity Questionnaire (IPAQ)
Time Frame
Baseline (PRE), after 3 months (MID), and after 6 months (POST).
Title
Current and past bone-loading physical activity levels
Description
Assessed by Bone-Specific Physical Activity Questionnaire (BPAQ).
Time Frame
Baseline (PRE).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Gualano, PhD
Phone
551126618022
Email
gualano@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Eimear Dolan, PhD
Phone
+447934771844
Email
eimeardolan@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eimear Dolan, PhD
Organizational Affiliation
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital of the School of Medicine, University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
Phone
551126618022
Email
gualano@usp.br
First Name & Middle Initial & Last Name & Degree
Eimear Dolan, PhD
Phone
+447934771844
Email
eimeardolan@usp.br
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
On study completion, and once data has been analysed and submitted for publication, anonymised individual participant data for all outcomes will be made available.
IPD Sharing Time Frame
Anonymised data will be made permanently available upon study completion and once data has been analysed and submitted for publication.
IPD Sharing Access Criteria
Anonymised data will be accessible to anyone interested via online repositories.
Learn more about this trial
Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
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