This randomized controlled trial (RCT) with two parallel study arms evaluated the effectiveness of a 24-week exercise intervention in prostate cancer (PCa) patients under-going androgen deprivation therapy (ADT). Ethical approval was obtained from the Clinical Research Ethics Committee of the University Clinical Hospital "Virgen de la Arrixaca" (Murcia, Spain). Participants were randomly assigned to one of two groups: (1) a supervised progressive resistance training program (SPoRT-PCa-ADT), or (2) a control group receiving a home-based exercise protocol following an initial assessment, accom-panied by weekly telephone follow-up. Assessments were conducted at baseline and at 24 weeks to examine changes in physical, functional, and psychosocial outcomes. Addi-tionally, patient-reported outcomes were collected at the 12-week midpoint (Figure 1). This study design enabled the evaluation of both immediate and sustained intervention effects and facilitated a direct comparison between supervised and home-based exercise approaches
diagnosis of locally advanced or metastatic prostate neoplasm and current treatment with androgen deprivation therapy (ADT)
treatment at the radiotherapy oncology department of University Clinical Hospital "Virgen de la Arrixaca"
legal adult age with signed informed consent
unwillingness to participate in the study
inability to complete adequate follow-up due to any cause that would prevent knowledge of patient evolution during the follow-up period
no controlled or symptomatic metastatic bone disease
physical disabilities that would prevent participants from safely completing the exercise protocol
Parallel
Exercise Intervention Protocol
Procedure/SurgerySubjects participated in the supervised exercise program twice weekly (with a 48-72-hour interval between sessions) for 24 weeks, totaling 48 supervised sessions. The progressive resistance training program used velocity-based training principles \[24-26\], a novel approach in exercise oncology that allows for precise load management and indi-vidualization based on daily performance capacity
SPoRT-Control Intervention
Procedure/Surgerystructured written instructions for a personalized home-based resistance training program. The protocol was designed to prioritize safety, progressive adaptation, and individualization based on each participant's functional capacity and available resources at home. The program was intended to be performed two to three times per week on non-consecutive days, focusing exclusively on lower-body training through a single primary movement. Each session consisted of three effective sets of 12 repetitions, which served as the standard training volume for the main exercise.
Progressive loading test
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.
Vertical jump test
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.
Maximum Isometric Contraction Test
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
Fatigue assessment
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
