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 |