Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill

Physical performance 3 months after ICU admission assessed by the 6-minute-walk distance test (6MWD) in metres. Absolute values will be compared to show a minimum absolute difference of 30 meters

Percentage of patients with 6 MWD at 6 months > 60% the distance walked in an age-matched and sex-matched control population

Percentage of patients with 6 MWD at 1 year > 65% the distance walked in an age-matched and sex-matched control population

11 items of Activities of Daily Living (ADL) and Instrumental

Activities of Daily Living (IADL):

Low muscle oxidative capacity is associated with muscle dysfunction and exercise intolerance in COPD patients and may contribute to reduce physical activity and quality of life in these patients. Muscle maximal oxidative capacity can be evaluated by oxygen muscular consumption which will be measured by Near Infrared Spectroscopy (NIRS), during a series of short arterial occlusions in muscle quadriceps. Studies performed in healthy subjects showed a good agreement with high-resolution respirometry and phosphorus magnetic resonance spectroscopy (P-MRS) for assessing mitochondrial respiratory capacity. In COPD patients, NIRS technique was feasible and well tolerated.

Mid-arm muscle circumference (MAMC) : MAMC (Mid-arm muscle circumference): MAMC is calculated using the following formula:

MAMC = mid-arm circumference - (3.14 × triceps skinfold thickness). The mid-arm circumference is measured using a standard flexible measuring tape on the left upper arm, at the mid-point between the olecranon process of the shoulder and the acromion, with the subject in a seated position. The triceps skinfold thickness is measured using a calibrated skinfold caliper (range 0.00- 50.00 mm; minimum graduation 0.2 mm) (85).

Percentage of patients with Short Physical Performance Battery < 10 at 3 months: The SPPB represents the sum of results from three component tests of functional relevance: standing balance, 4-meter gait speed (4MGS), and fiverepetition sit-to-stand motion (5STS). Each component is scored based on a subscale, and the three subscores are added to obtain a summary score. The SPPB is a high-level physical function outcome as it examines gait speed, balance control and sit-to-stand repetitions. It has been commonly used in COPD patients. In critical ill patients, the SPPB may be more appropriate as a measure in the post ICU setting in the acute hospital wards or post hospital discharge.

Physical component of SF 36 (Medical Outcomes Study 36 Item Short Form Health):

The physical component of SF 36 is a commonly used and well validated instrument in critical ill patients. The SF 36 has demonstrated reliability, validity and responsiveness and is recommended in ICU populations.

Kg and percent of the predicted force: Hand-grip strength (HGS) is a manual muscle test that enables measurement of force using a calibrated device. It is reliable, rapid and simple and can serve as a surrogate for global strength. Normative data are available. HGS has been commonly used in critical ill patients.

MRC has been routinely used in critical care research to screen for muscle weakness. It classifies muscle contraction on a 0-5 point ordinal scale. Six muscle groups will be assessed bilaterally.

Number of day without ventilation

Number of date between ICU admission and ICU discharge

Number of date between ICU admission and hospital discharge

rate of patient included in the study and died at day 28

rate of patient included in the study and died at day 90

rate of patient included in the study and died at ICU discharge

rate of patient included in the study and died at hospital discharge

Safety of testosterone gel