Standardized Resistance Training Program and Assessment System for Prostate Cancer Patients Receiving Androgen Deprivation Therapy ISPoRT-PCa-ADT Study Protocol for a Randomized Controlled Trial. SPORT-MU

Primary outcomes

1. Progressive loading test

   Time frame: Up for a 24 weeks

   squat (SQ) exercise to evaluate strength and velocity parameters. Participants performed the SQ starting from an upright position with knees and hips fully extended, feet parallel and shoulder-width apart, and the bar resting on the upper back at the acromion level. Each participant descended continuously until the top of the thighs were below the horizontal plane, with the posterior thighs and shins in contact (~35-40° knee flexion), then immediately reversed the movement to return to the upright position.

2. Vertical jump test

   Time frame: up for 24 weeks

   In the countermovement jump (CMJ) test, participants performed five maximum CMJs with 20-second rests between jumps. Before CMJ evaluation, participants warmed up by performing two sets of 10 squats without external load, 5 submaximal CMJs, and 3 maximum CMJs. CMJ height was calculated from flight time values determined using a contact platform (Chronojump Boscosystem®, Barcelona, Spain). After discarding the highest and lowest CMJ heights, the resulting average was retained for further analysis. This test was employed as a measure of lower body power and neuromuscular function, which are commonly impaired in patients undergoing ADT.

3. Maximum Isometric Contraction Test

   Time frame: up for 24 weeks

   Maximum isometric force (MIF) and maximum rate of force development (RFDmax) were measured during a maximum voluntary isometric contraction (MVIC) test in the squat (SQ) exercise with participants standing and knees flexed at 90° (180° = full exten-sion). This test was performed on a quadriceps extension machine. Participants were in-structed to push against the force platform as quickly and forcefully as possible following the "ready, set, go!" signal during two 5-second trials separated by 1-minute rests. External forces were recorded at a sampling rate of 1000 Hz and processed using specific software (Chronojump Boscosystem®, Barcelona, Spain). RFDmax was calculated as the maximum slope in the time-force curve over 20 ms intervals. Additionally, the average tangential slope of the time-force curve obtained at different time intervals (50, 100, and 150 ms from the onset of force production, RFD0-50, RFD0-100, and RFD0-150, respec-tively) was calculated. The average value of each var

4. Fatigue assessment

   Time frame: Up for 24 weeks

   Cancer-related fatigue, one of the most common and debilitating side effects of cancer treatment and ADT, was assessed using the Brief Fatigue Inventory (BFI). This validated 9-item questionnaire measures the severity of fatigue and its interference with daily activities. Scores are categorized as mild (1-3), moderate (4-6), or severe (7-10) fatigue. The BFI has demonstrated excellent reliability and validity in cancer populations and is sensitive to changes following exercise interventions

5. Quality of Life Assessment

   Time frame: Up for a 24 weeks

   Quality of life was evaluated using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. This 39-item instrument comprises the FACT-General (FACT-G) plus a prostate cancer subscale (PCS) that assesses concerns specific to prostate cancer and its treatment. The FACT-P evaluates physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing, and prostate cancer-specific concerns. Higher scores indicate better quality of life. This instrument has been extensively validated in prostate cancer populations and demonstrates good sensitivity to change following interventions

6. Psychological Distress

   Time frame: Up for 24 weeks

   Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire designed to identify anxiety and depression in patients with physical health problems. The scale produces separate scores for anxiety and depression. The HADS has been validated in cancer populations and is widely used in psycho-oncology research

7. Urinary Function

   Time frame: Up for a 24 weeks

   Urinary function, which can be affected by both prostate cancer and its treatments, was assessed using the International Prostate Symptom Score (IPSS). This 8-item questionnaire evaluates the severity of lower urinary tract symptoms associated with benign prostatic hyperplasia and other conditions affecting urinary function in men. The total symptom score ranges from 0 to 35, with higher scores indicating more severe symptoms. Additionally, includes an ancillary query regarding the patient's quality of life related to urinary symptoms, thereby providing a comprehensive evaluation that supports both diagnostic and therapeutic decision-making in clinical practice

8. Sleep Quality

   Time frame: Up for a 24 weeks

   Sleep disturbances are common in cancer patients and can significantly impact quality of life. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that evaluates sleep quality and disturbances over a one-month period