Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)
NCT ID: NCT05090189
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-08-27
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise training
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.
Exercise Training
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.
Control
The control group will receive standard medical care.
No interventions assigned to this group
Interventions
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Exercise Training
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.
Eligibility Criteria
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Inclusion 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
* 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).
18 Years
45 Years
FEMALE
No
Sponsors
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Bruno Gualano
OTHER
Responsible Party
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Bruno Gualano
Professor
Principal Investigators
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Eimear Dolan, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
Locations
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Clinical Hospital of the School of Medicine, University of Sao Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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The ENRG Study
Identifier Type: -
Identifier Source: org_study_id