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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