Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Peripheral oxygen saturation |
Peripheral oxygen saturation will be assessed by pulse oximetry |
baseline |
|
Primary |
Peripheral oxygen saturation |
Peripheral oxygen saturation will be assessed by pulse oximetry |
During the procedure: Protocol 1: minute four; Protocol 2: minute eight |
|
Primary |
Peripheral oxygen saturation |
Peripheral oxygen saturation will be assessed by pulse oximetry |
Immediately after the session |
|
Primary |
Respiratory rate |
Respiratory rate will be assessed by respiratory rate count for one minute |
baseline |
|
Primary |
Respiratory rate |
Respiratory rate will be assessed by respiratory rate count for one minute |
During the procedure: Protocol 1: minute four; Protocol 2: minute eight |
|
Primary |
Respiratory rate |
Respiratory rate will be assessed by respiratory rate count for one minute |
Immediately after the session |
|
Primary |
Heart rate |
Heart rate will be assessed by pulse oximetry |
baseline |
|
Primary |
Heart rate |
Heart rate will be assessed by pulse oximetry |
During the procedure: Protocol 1: minute four; Protocol 2: minute eight |
|
Primary |
Heart rate |
Heart rate will be assessed by pulse oximetry |
Immediately after the session |
|
Primary |
Systolic blood pressure |
Systolic blood pressure will be assessed through sphygmomanometer |
baseline |
|
Primary |
Systolic blood pressure |
Systolic blood pressure will be assessed through sphygmomanometer |
Immediately after the session |
|
Primary |
Diastolic blood pressure |
Diastolic blood pressure will be assessed through sphygmomanometer |
baseline |
|
Primary |
Diastolic blood pressure |
Diastolic blood pressure will be assessed through sphygmomanometer |
Immediately after the session |
|
Primary |
Dyspnea and fatigue |
Dyspnea and fatigue will be assessed through Borg's perceived exertion scale |
baseline |
|
Primary |
Dyspnea and fatigue |
Dyspnea and fatigue will be assessed using a subjective perceived exertion scale ranging from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximum dyspnea. |
During the procedure: Protocol 1: minute four; Protocol 2: minute eight |
|
Primary |
Dyspnea and fatigue |
Dyspnea and fatigue will be assessed using a subjective perceived exertion scale ranging from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximum dyspnea. |
Immediately after the session |
|
Primary |
Autonomic control |
Autonomic control will be assessed through variability heart rate |
baseline |
|
Primary |
Autonomic control |
Autonomic control will be assessed through variability heart rate |
up to 10 minutes after the session |
|
Primary |
Adverse events |
Occurence of adverse events will be assessed through patient report |
Immediately after the session |
|
Primary |
Adverse events |
Occurence of adverse events will be assessed through patient report |
24 hours after the session |
|
Primary |
Adverse events |
Occurence of adverse events will be assessed through patient report |
48 hours after the session |
|
Primary |
Adverse events |
Occurence of adverse events will be assessed through patient report |
72 hours after the session |
|
Secondary |
Muscle damage |
Assessed through the serum level of creatine kinase (CK) |
Baseline |
|
Secondary |
Muscle damage |
Assessed through the serum level of creatine kinase (CK) |
Immediately after the session |
|
Secondary |
Muscle damage |
Assessed through the serum level of creatine kinase (CK) |
24 hours after the session |
|
Secondary |
Muscle damage |
Assessed through the serum level of creatine kinase (CK) |
48 hours after the session |
|
Secondary |
Muscle damage |
Assessed through the serum level of creatine kinase (CK) |
72 hours after the session |
|
Secondary |
Muscle fatigue |
Assessed through the serum lactate level |
baseline |
|
Secondary |
Muscle fatigue |
Assessed through the serum lactate level |
Immediately after the session |
|
Secondary |
Muscle fatigue |
Assessed through the serum lactate level |
3 minutes after the session |
|
Secondary |
Muscle fatigue |
Assessed through the serum lactate level |
6 minutes after the session |
|
Secondary |
Delayed onset muscle pain |
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain |
baseline |
|
Secondary |
Delayed onset muscle pain |
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain |
Immediately after the session |
|
Secondary |
Delayed onset muscle pain |
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain |
24 hours after the session |
|
Secondary |
Delayed onset muscle pain |
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain |
48 hours after the session |
|
Secondary |
Delayed onset muscle pain |
Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain |
72 hours after the session |
|
Secondary |
Peripheral muscle strength |
Assessed by dynamometry |
baseline |
|
Secondary |
Peripheral muscle strength |
Assessed by dynamometry |
up to 40 minutes after the session |
|