A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: Protocol and rationale of the Take a STAND for Health study

Ana Jessica Pinto, Tiago Peçanha, Kamila Meireles, Fabiana Braga Benatti, Karina Bonfiglioli, Ana Lúcia de Sá Pinto, Fernanda Rodrigues Lima, Rosa Maria Rodrigues Pereira, Maria Claudia Costa Irigoyen, James Turner, John P Kirwan, Neville Owen, David W Dunstan, Hamilton Roschel, Bruno Gualano

Research output: Contribution to journalArticle

Abstract

Background: Rheumatoid arthritis patients spend most of their daily hours in sedentary behaviors (sitting), a predisposing factor to poor health-related outcomes and all-cause mortality. Interventions focused on reducing sedentary time could be of novel therapeutic relevance. However, studies addressing this topic remain scarce. We aim to investigate the feasibility and efficacy of a newly developed intervention focused on reducing sedentary time, and potential clinical, physiological, metabolic and molecular effects in rheumatoid arthritis.

Methods: The Take a STAND for Health study is a 4-month, parallel-group, randomized controlled trial, in which postmenopausal rheumatoid arthritis patients will set individually-tailored, progressive goals to replace their sedentary time with standing and light-intensity activities. Patients will be recruited from the Clinical Hospital (School of Medicine, University of Sao Paulo) and will be assessed at baseline and after a 4-month follow-up. Outcomes will include: objectively measured sedentary behavior (primary outcome) and physical activity levels, clinical parameters, anthropometric parameters and body composition; aerobic fitness, muscle function, blood pressure, cardiovascular autonomic function, vascular function and structure, health-related quality of life, and food intake. Blood and muscle samples will be collected for assessing potential mechanisms, through targeted and non-targeted approaches.

Discussion: Findings will be of scientific and clinical relevance, with the potential to inform new prescriptions focused on reducing sedentary behavior, a modifiable risk factor that thus far has been overlooked in rheumatoid arthritis patients.

Trial registration: ClinicalTrials.gov identifier: NCT03186924; registered on 14 June 2017 (https://clinicaltrials.gov/ct2/show/NCT03186924).
Original languageEnglish
Article number171
JournalTrials
Volume21
Issue number1
Early online date12 Feb 2020
DOIs
Publication statusPublished - 12 Feb 2020

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