An interventional study of Exercise Intervention Protocol and SPoRT-Control Intervention in Prostate Cancer, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Not yet recruiting at 1 site in Spain. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Not applicable, Interventional, and Treatment
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
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
Exclusion Criteria:
24 week velocity based resistance training. Twice weekly supervised sessions
Procedure: SPoRT-Control Intervention
24-week home based resistance training program .
Procedure: Exercise Intervention Protocol
Subjects 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
structured 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.
Time frame: Up for a 24 weeks
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.
Time frame: up for 24 weeks
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
Time frame: up for 24 weeks
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
Time frame: Up for 24 weeks
Quality of Life Assessment
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
Time frame: Up for a 24 weeks
Psychological Distress
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
Time frame: Up for 24 weeks
Urinary Function
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
Time frame: Up for a 24 weeks
Sleep Quality
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
Time frame: Up for a 24 weeks
Plan to share: Undecided
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia