Prostate CancerSPORT-MUNCT07064811
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
A study testing Exercise Intervention Protocol in people with Prostate Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise Intervention Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2025to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alejandro Soler López contact
Spain1 site
HCUVA
Murcia, Murcia, 30120
Enrique Cao Avellaneda, MD, 968369500, enriquecao@hotmail.com
Alejandro Soler Lopez, a.solerlopez@um.es
About this study
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
Read the detailed description
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
- Conditions
- Prostate Cancer
- Being tested
- Exercise Intervention Protocol, SPoRT-Control Intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention ProtocolProcedure or surgery
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
SPoRT-Control InterventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SPORT Protocol intervention | Experimental | 24 week velocity based resistance training. Twice weekly supervised sessions Receives: Procedure: SPoRT-Control Intervention |
| SPORT Control intervention | Active comparator | 24-week home based resistance training program . Receives: Procedure: Exercise Intervention Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up for a 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Soler López, Principal investigator, Department of Physical Activity and Sport, Faculty of Sport Science, University of Murcia,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064811
- Sponsor's protocol ID
- SPORT-MU
- Acronym
- SPORT-MU
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soler-Lopez A, Gomez-Carmona CD, Gonzalez-Devesa D, Lopez-Plaza D, Herrero-Vidal L, Toledo-Pozuelo R, Gonzalez-Costea A, Cao-Avellaneda E. Standardized Program of Resistance Training for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (SPoRT-PCa-ADT): study protocol for a randomized controlled trial. BMC Cancer. 2026 Apr 22;26(1):711. doi: 10.1186/s12885-026-15902-w.
PubMed 42015017
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07064811
- Acronym / sponsor ID
- SPORT-MU / SPORT-MU
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPORT Protocol intervention | Experimental | Procedure: SPoRT-Control Intervention24 week velocity based resistance training. Twice weekly supervised sessions |
| SPORT Control intervention | Active comparator | Procedure: Exercise Intervention Protocol24-week home based resistance training program . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Intervention ProtocolSubjects 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 | Procedure or surgery | SPORT Control intervention |
| SPoRT-Control Interventionstructured 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. | Procedure or surgery | SPORT Protocol intervention |
Primary outcome
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.
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.
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 42015017Soler-Lopez A, Gomez-Carmona CD, Gonzalez-Devesa D, Lopez-Plaza D, Herrero-Vidal L, Toledo-Pozuelo R, Gonzalez-Costea A, Cao-Avellaneda E. Standardized Program of Resistance Training for Prostate Cancer Patients Receiving Androgen Deprivation Therapy (SPoRT-PCa-ADT): study protocol for a randomized controlled trial. BMC Cancer. 2026 Apr 22;26(1):711. doi: 10.1186/s12885-026-15902-w.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Soler López contact
Alejandro Soler López principal investigator
Department of Physical Activity and Sport, Faculty of Sport Science, University of Murcia,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention Protocol in people with Prostate Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrique Cao Avellaneda, MD (968369500, enriquecao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive loading test (time frame: Up for a 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07064811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.