Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Perfusion of the skin microcirculation |
Perfusion of skin microcirculation is demonstrated non-invasively using the Laser Speckle Contrast Imager (moorFLPI 2, moor instruments, www.moor.co.uk). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the perfusion of the skins' microcirculation. |
30 minutes |
|
Primary |
Oxygenation of the muscles and the brain |
Muscle and brain oxygen saturation is measured non-invasively using a deep tissue oxygenation monitor (moorVMS-NIRS, moor instruments, www.moor.co.uk). For this purpose, adhesive electrodes are applied over the muscle and the forehead. This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the muscles and the brain. |
30 minutes |
|
Primary |
Oxygenation of the blood |
The oxygen saturation of the blood is measured with a portable pulse oximeter with finger clip probe (Nonin 7500, Nonin medical B.V., Plymouth, USA). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the oxygenation of the blood. |
30 minutes |
|
Primary |
Blood pressure |
Blood pressure (systolic and diastolic) is detected by an electronically automated upper arm blood pressure monitor (Boso-Medicus uno). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the blood pressure. |
30 minutes |
|
Primary |
Heart rate |
The heart rate is measured using a pulse belt and an additional 2-point ECG (Actiheart, Camntech Ltd., Cambridge, UK). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the heart rate. |
30 minutes |
|
Primary |
Skin temperature |
Skin temperature is measured using the iButton system (www.ibuttonlink.com). The self-adhesive sensors wirelessly transmit skin temperature information to a computer. Furthermore, the skin temperature is recorded by means of a thermal imaging camera (FLIR). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for the skin temperature. |
30 minutes |
|
Primary |
Concentration of blood lactate and creatine kinase |
Lactate and creatine kinase measurements are performed by capillary blood measurement (Accutrend, Roche Diagnostic, Red Cross, Switzerland & Reflotron, Roche Diagnostic, Rotkreuz, Switzerland). This measurement is taken during the baseline measurements, after the step-up task and up to 30 minutes after the cold water bath of the hand (5 minute interval). This outcome measure reports the change from baseline for lactate and creatine kinase. |
30 minutes |
|
Primary |
Balance |
The fluctuations of the hull are recorded and evaluated with the Sway Star Systems (www.b2i.info). The Sway Star is a measuring instrument that contains gyroscopes. It is attached to a strap which is applied around the waist of the patient. The data is evaluated with the associated Sway Star software and transferred to the data sheet. This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for balance. |
30 minutes |
|
Primary |
Pain threshold: pain pressure gauge |
The pain threshold is measured by means of a pain pressure gauge (NOD, www.to-nod.com). This measurement is performed after the baseline measurement and after the cold water bath immersion of the hand. This outcome measure reports the change from baseline for pain threshold. |
30 minutes |
|
Primary |
Sleep disorder |
Sleep disorder is measured with "Standford sleepiness scale", choosing one answer from seven (1=no sleepiness, 7=extreme sleepiness). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|
Primary |
Altitude sickness |
Altitude sickness is measured with "Lake Louis acute mountain sickness scale", choosing the most appropriate answer from 5 questions. Questions range from 0 (=no symptoms) to 4 (=severe symptoms).The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|
Primary |
Dyspnoea |
Dyspnoea is measured with the "modified BORG scale", choosing a number from 0 (=no dyspnoea) to 10 (=maximum dyspnoea). The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|
Primary |
Mental state |
Mental state is assessed using "profile of the mood state", answering 37questions. Each question has a score from 0 (=not at all) to 4 (=extremely). The total sum of the scores is used. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|
Primary |
Cognition |
Cognitive tests consists of 8 tasks (automated neuropsychological assessment metrics). Lower values are better than higher values and are analyzed individually. The measurements are performed at baseline and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|
Secondary |
Thermal comfort and sensation |
These parameters are measured by a thermal comfort scale (ranging from 0 [comfortable] to +4 [very uncomfortable]) and a thermal sensation scale (ranging from -4 [ver cold] to +4 [very hot]). These measurements are performed after the baseline measurement and after the cold water bath immersion of the hand and report the change from baseline. |
30 minutes |
|