Skip to main content

Table 1 Study design, activities, phases and responsible persons

From: Good safety practice in a randomized controlled trial (CadColdEx) involving increased cardiac workload in patients with coronary artery disease

Activity Phase of the project Responsible person
Determining eligibility for participation, agreeing of the study protocol and required safety measures Planning Research team
Employing agreed selection criteria Selection of patients from medical records Cardiologist
Confirmation of eligibility Contact with patients: pre-screening for eligibility, inquiring of willingness to receive further information Cardiologist
Confirmation of eligibility Contact with patients (n = 22): informing of the study, screening of health through a questionnaire, invitation to participate to tests assessing physical capacity Researcher
Confirmation of eligibility, use of exercise information to the experiments, employing termination criteria, constant monitoring Assessment of physical capacity (n = 20), graded bicycle ergometer test, measurement of ECG, acquiring informed consent to participate to the experimental study Researchers, expert in exercise physiology, medical doctor (on site)
Planning of experiment, employing agreed termination criteria, constant health monitoring Randomised controlled study (n = 18 × 4): exercise or rest at − 15 °C or + 22 °C (baseline, exercise, follow-up), assessment of cardiovascular function (HR, ECG, BP), perceived exertion, thermal sensations, assessment of possible other symptoms Researchers, emergency nurse, medical doctor (monitoring on call)
Post-experiment follow-up Follow-up after the experiment (n = 18), 24 h monitoring of BP and ECG Researcher, participant