Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial
- Publikationstyp:
- Zeitschriftenaufsatz
- Metadaten:
-
- Autoren
- Simone Cosima Boedecker
- Keito Finn Akanby Philippi
- Elmo Neuberger
- Sebastian Schmidt
- Daniel Pfirrmann
- Nils Haller
- Andreas Schwarting
- Perikles Simon
- Julia Weinmann-Menke
- Autoren-URL
- https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=fis-test-1&SrcAuth=WosAPI&KeyUT=WOS:000601314500016&DestLinkType=FullRecord&DestApp=WOS_CPL
- DOI
- 10.2196/18291
- Externe Identifier
- Clarivate Analytics Document Solution ID: PI8DJ
- PubMed Identifier: 33141101
- ISSN
- 1929-0748
- Ausgabe der Veröffentlichung
- 11
- Zeitschrift
- JMIR RESEARCH PROTOCOLS
- Schlüsselwörter
- systemic lupus erythematosus
- physical activity
- internet-based exercise program
- disease activity
- fatigue
- Artikelnummer
- ARTN el8291
- Datum der Veröffentlichung
- 2020
- Status
- Published
- Titel
- Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial
- Sub types
- Article
- Ausgabe der Zeitschrift
- 9
Datenquelle: Web of Science (Lite)
- Andere Metadatenquellen:
-
- Abstract
- <jats:sec> <jats:title>Background</jats:title> <jats:p>Systemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>This study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Overall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial Registration</jats:title> <jats:p>ClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718.</jats:p> </jats:sec> <jats:sec> <jats:title>International Registered Report Identifier (IRRID)</jats:title> <jats:p>DERR1-10.2196/18291</jats:p> </jats:sec>
- Autoren
- Simone Cosima Boedecker
- Keito Finn Akanby Philippi
- Elmo Neuberger
- Sebastian Schmidt
- Daniel Pfirrmann
- Nils Haller
- Andreas Schwarting
- Perikles Simon
- Julia Weinmann-Menke
- DOI
- 10.2196/18291
- eISSN
- 1929-0748
- Ausgabe der Veröffentlichung
- 11
- Zeitschrift
- JMIR Research Protocols
- Sprache
- en
- Online publication date
- 2020
- Paginierung
- e18291 - e18291
- Status
- Published online
- Herausgeber
- JMIR Publications Inc.
- Herausgeber URL
- http://dx.doi.org/10.2196/18291
- Datum der Datenerfassung
- 2020
- Titel
- Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial
- Ausgabe der Zeitschrift
- 9
Datenquelle: Crossref
- Abstract
- <h4>Background</h4>Systemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation.<h4>Objective</h4>This study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.<h4>Methods</h4>Overall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles.<h4>Results</h4>The study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021.<h4>Conclusions</h4>We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.<h4>Trial registration</h4>ClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718.<h4>International registered report identifier (irrid)</h4>DERR1-10.2196/18291.
- Addresses
- Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.
- Autoren
- Simone Cosima Boedecker
- Keito Finn Akanby Philippi
- Elmo Neuberger
- Sebastian Schmidt
- Daniel Pfirrmann
- Nils Haller
- Andreas Schwarting
- Perikles Simon
- Julia Weinmann-Menke
- DOI
- 10.2196/18291
- eISSN
- 1929-0748
- Externe Identifier
- PubMed Identifier: 33141101
- PubMed Central ID: PMC7671835
- Open access
- true
- ISSN
- 1929-0748
- Ausgabe der Veröffentlichung
- 11
- Zeitschrift
- JMIR research protocols
- Sprache
- eng
- Medium
- Electronic
- Online publication date
- 2020
- Open access status
- Open Access
- Paginierung
- e18291
- Datum der Veröffentlichung
- 2020
- Status
- Published
- Publisher licence
- CC BY
- Datum der Datenerfassung
- 2020
- Titel
- Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial.
- Sub types
- research-article
- Journal Article
- Ausgabe der Zeitschrift
- 9
Datenquelle: Europe PubMed Central
- Abstract
- BACKGROUND: Systemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation. OBJECTIVE: This study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training. METHODS: Overall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles. RESULTS: The study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021. CONCLUSIONS: We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus. TRIAL REGISTRATION: ClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18291.
- Date of acceptance
- 2020
- Autoren
- Simone Cosima Boedecker
- Keito Finn Akanby Philippi
- Elmo Neuberger
- Sebastian Schmidt
- Daniel Pfirrmann
- Nils Haller
- Andreas Schwarting
- Perikles Simon
- Julia Weinmann-Menke
- Autoren-URL
- https://www.ncbi.nlm.nih.gov/pubmed/33141101
- DOI
- 10.2196/18291
- Externe Identifier
- PubMed Central ID: PMC7671835
- ISSN
- 1929-0748
- Ausgabe der Veröffentlichung
- 11
- Zeitschrift
- JMIR Res Protoc
- Schlüsselwörter
- fatigue
- internet-based exercise program, disease activity
- physical activity
- systemic lupus erythematosus
- Sprache
- eng
- Country
- Canada
- Paginierung
- e18291
- PII
- v9i11e18291
- Datum der Veröffentlichung
- 2020
- Status
- Published online
- Titel
- Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial.
- Sub types
- Journal Article
- Ausgabe der Zeitschrift
- 9
Datenquelle: PubMed
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- Eigentum von