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 Edward Turner, John P Kirwan, Neville Owen, David W Dunstan, Hamilton Roschel, Bruno Gualano, 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 Edward Turner, John P Kirwan, Neville Owen, David W Dunstan, Hamilton Roschel, Bruno Gualano

Abstract

Background: Patients with rheumatoid arthritis spend most of their daily hours in sedentary behavior (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 patients with rheumatoid arthritis 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 patients with rheumatoid arthritis.

Trial registration: ClinicalTrials.gov, NCT03186924. Registered on 14 June 2017.

Keywords: Light-intensity physical activity; Rheumatic arthritis; Sitting.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overall schedule of enrollment, intervention, and assessments following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist
Fig. 2
Fig. 2
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
Fig. 3
Fig. 3
Overall design of the Take a STAND for Health intervention
Fig. 4
Fig. 4
Time spent in sedentary behavior, standing, and stepping (hours/day) before and after the pilot study. *Significant difference when compared to baseline (P < 0.050)
Fig. 5
Fig. 5
Summary of the blood and muscle analyses. ACACA, acetyl-coenzyme A carboxylase α; Akt, protein kinase B; AS160, Akt substrate of 160 kDa; AMPK, phosphorylated 5′ adenosine monophosphate-activated protein kinase; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; GLUT4, glucose transporter type 4; HbA1C, glycosylated hemoglobin; Lipid profile (triglycerides, total cholesterol, HDL, LDL, and VLDL); LPL, lipoprotein lipase; OXPHOS, oxidative phosphorylation complexes; PDK4, pyruvate dehydrogenase kinase 4

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