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Applying Exercise Capacity and Physical Activity as Single vs Composite Endpoints for Trials of Cardiac Rehabilitation Interventions: Rationale, Use-case, and a Blueprint Method for Sample Size Calculation.

Anna Eleonora CarrozzoVeronique CornelissenArne C BathkeJomme ClaesJosef NiebauerGeorg ZimmermannGunnar TreffStefan Tino Kulnik
Published in: Archives of physical medicine and rehabilitation (2024)
Trialists may consider the utility of the CE for future studies in exercise-based CR to reduce sample size requirements. However, perhaps surprisingly at first, the CE could also lead to an increased sample size needed, depending on the observed baseline proportions in the trial population and the aim of the intervention.
Keyphrases
  • physical activity
  • high intensity
  • clinical trial
  • randomized controlled trial
  • body mass index
  • study protocol
  • resistance training
  • phase iii
  • phase ii
  • current status
  • sleep quality
  • open label