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

Trials. 2020 Feb 12;21(1):171. doi: 10.1186/s13063-020-4104-y.

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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Arthritis, Rheumatoid / psychology*
  • Blood Pressure
  • Body Composition
  • Eating
  • Exercise
  • Female
  • Follow-Up Studies
  • Health Surveys
  • Humans
  • Postmenopause*
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Sedentary Behavior*
  • Sitting Position
  • Text Messaging

Associated data

  • ClinicalTrials.gov/NCT03186924