Modifications to the study protocol following pretrial interviews with unit staff
| Trial protocol item | Initial plan/barrier | Modification |
|---|---|---|
| In-servicing format | Didactic sessions on the benefits of exercise in people with ESRD and one practical session with the exercise equipment | Two practical in-services on study procedures and equipment set-up Video posted on YouTube on the exercises and how to assist patients with equipment set-up Education materials (articles, pamphlets, summaries) on IDE placed on the unit for staff |
| Workspace safety for staff | Exercise equipment as workspace hazard | Unit staff identified where equipment would be stored on the unit With unit staff input, protocols for equipment set-up and removal were written into study protocol |
| Recruitment | Only study staff selects suitable candidates | Prior to enrolling a patient, the charge nurse was consulted regarding any dialysis-related safety concerns |
| Implementation | Include several unit staff members as volunteer ‘exercise champions’ to lead unit staff and liaise with study staff | No volunteers found. Identified four staff ‘point people’ who were already in leadership roles in the unit to informally check in with study staff on trial implementation |
ESRD, end-stage renal disease; IDE, intradialytic exercise.