Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Microcirculatory function |
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed. |
Baseline. |
|
Primary |
Microcirculatory function |
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed. |
8 weeks. |
|
Secondary |
Anthropometry - 1 |
Stature, waist and hip circumferences will be measured (all in cms). |
Baseline. |
|
Secondary |
Anthropometry - 1 |
Stature, waist and hip circumferences will be measured (all in cms). |
8 weeks. |
|
Secondary |
Anthropometry - 2 |
Body mass will be measured. |
Baseline. |
|
Secondary |
Anthropometry - 2 |
Body mass will be measured. |
8 weeks. |
|
Secondary |
SF-IPAQ |
The SF-IPAQ questionnaire will be completed, to assess physical activity levels. |
Baseline. |
|
Secondary |
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2). |
A discontinuous, sub-maximal test, involving four rounds of exercise will measure the participants' transcutaneous oxygen pressure (TcPO2).TcPO2 values will be measured and recorded by a sensor. Measurements will be taken, using a TINA TCM400 TcPO2 device (Radiometer, Copenhagen, Denmark). The electrode will be placed on the participants' back, below the right scapula. The testing protocol includes a total of 20 min on a cycle ergometer (Monark894E, Vansbro, Sweden) with a 2-min break after each 5 min of exercise. Participants will maintain a speed of 80 revolutions per minute, and after each 5-min period, an extra 0.2 kg of resistance will be added to the ergometer, with a 1 kg of starting resistance value. Participants will be encouraged to reach their maximum exertion limit before completing the assessment but could stop before the end of the test if they feel so. |
Baseline |
|
Secondary |
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2). |
A discontinuous, sub-maximal test, involving four rounds of exercise will measure the participants' transcutaneous oxygen pressure (TcPO2).TcPO2 values will be measured and recorded by a sensor. Measurements will be taken, using a TINA TCM400 TcPO2 device (Radiometer, Copenhagen, Denmark). The electrode will be placed on the participants' back, below the right scapula. The testing protocol includes a total of 20 min on a cycle ergometer (Monark894E, Vansbro, Sweden) with a 2-min break after each 5 min of exercise. Participants will maintain a speed of 80 revolutions per minute, and after each 5-min period, an extra 0.2 kg of resistance will be added to the ergometer, with a 1 kg of starting resistance value. Participants will be encouraged to reach their maximum exertion limit before completing the assessment but could stop before the end of the test if they feel so. |
8 weeks. |
|
Secondary |
Blood pressure |
Diastolic and systolic blood pressure will be recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA). |
Baseline. |
|
Secondary |
Blood pressure |
Diastolic and systolic blood pressure will be recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA). |
8 weeks. |
|