Radar de Ensayos Clínicos

Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks

Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.

Baseline, 12 weeks, and 24 weeks

Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks

The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).

Baseline, 12 weeks, and 24 weeks

Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

By measuring resting and exercise -associated left ventricular (LV) end-diastolic (EDV) and end-systolic volumes (ESV) we will calculate stroke volume (SV) in milliliters/beat (ml). SV = EDV - ESV

Baseline, 12 weeks

Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

By measuring resting and exercise-associated stroke volumes (SV) as a proportion of end-diastolic volumes (EDV) we will calculate left ventricular ejection fraction (%). LVEF = SV/EDV

Baseline, 12 weeks

Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

By measuring resting and exercise-associated stroke volume (SV) and the heart rate (HR) in conjunction with image acquisition we will calculate cardiac output in liters per minute (L/min). CO = SV x HR

Baseline, 12 weeks

Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

From the exercise tests we will calculate a-vO2 difference using the FICK equation. The difference in oxygen saturation between the venous circulation and the arterial circulation will be reported in milliliters (ml) and also expressed as ml/100ml of blood (%) a-vO2 = VO2 / CO

Baseline, 12 weeks

Change in lean body mass

We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for lean body mass. Lean body mass will be reported as kilograms (kg)

Baseline, 12 weeks

Change in fat mass

We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for fat mass as well as distribution patterns of adiposity, e.g., visceral adipose tissue. Fat mass and visceral fat mass will be reported in kilograms (kg) and body fat percentage will be reported as fat mass / body mass (%)

Baseline, 12 weeks

Neighborhood Environment & Walkability Survey (NEWS-A)

NEWS-A is a validated self-reported survey used to assess factors that are correlates or determinants of participants ability to engage in physical activity in their neighborhoods. For example, higher walkability is determined by availability of sidewalks and access to nearby facilities.

Baseline, 12 weeks, 24 weeks

Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

GLTEQ is a self-report survey to determine the level typical activity a participant engages in each week. Higher scores on the index indicate more activity.

Baseline, 12 weeks, 24 weeks

Change in physical activity assessed with Accelerometry

The ActivPAL and Actigraph accelerometers provide an objective assessment of sedentary sitting time and increasing intensities of physical activity in minutes per week

Baseline, 12 weeks, 24 weeks

Change in self-efficacy to navigate barriers to engaging in exercise

A self report of self-efficacy to engage in exercise or physical activity under different challenging conditions such as when experiencing fatigue. Higher scores indicate increased confidence to navigate barriers.

Baseline, 12 weeks, 24 weeks

Change in self-efficacy to walk for increasing periods of time.

A self report of self-efficacy to engage in walking for an increasing period of time. Higher scores indicate increased confidence to walk for a longer periods of time without resting.

Baseline, 12 weeks, 24 weeks

Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores

FACT-P is a validated self report measures of different domains of quality of life that are important for men who have been diagnosed with prostate cancer. Subscale scores can be assessed to gauge functional wellbeing, physical wellbeing, social wellbeing and emotional wellbeing as well as prostate specific wellbeing. Higher scores indicate a higher quality of life on overall and sub scales.

Baseline, 12 weeks, 24 weeks

Change in health-related quality of life (SF-36) scores

SF-36 (RAND) is a validated self report measure of different domains of health-related quality of life that are important for adults. Higher scores indicate a higher health-related quality of life .

Baseline, 12 weeks, 24 weeks

Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores

PROMIS - Fatigue is a validated self-report measure of fatigue among patients diagnosed with cancer and higher scores indicate a lower level of fatigue.

Baseline, 12 weeks, 24 weeks

Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores

PROMIS - Physical Functioning is a validated self-report measure of physical functioning among patients diagnosed with cancer and higher scores indicate a better function.

Baseline, 12 weeks, 24 weeks

Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores

PROMIS - Sleep Disturbance is a validated self-report measure of sleep disturbance among patients diagnosed with cancer and higher scores indicate less sleep disruption.

Baseline, 12 weeks, 24 weeks

Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores

PROMIS - Depression is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

Baseline, 12 weeks, 24 weeks

Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores

PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

Baseline, 12 weeks, 24 weeks

Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores

PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

Baseline, 12 weeks, 24 weeks

Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale

FACUT-F is a validated self-report measure of fatigue among patients undergoing treatment for a chronic illness and higher scores indicate less fatigue.

Baseline, 12 weeks, 24 weeks

Change in perceived stress as measured with Cohen's perceived stress scale (PSS)

PSS is a validated self-report measure of perceived stress and higher scores indicate more perceived stress.

Baseline, 12 weeks, 24 weeks

Change in physical function assessed with the Short Physical Performance Battery (SPPB)

SPPB is a validated objective assessment of 3 domains of physical function that includes gait speed, grip strength and time taken to stand from a chair 5 times. Each down is scored on a scale of 0-4 with a total score summed from each domain. A higher score is indicative of better functioning.

Baseline, 12 weeks, 24 weeks