Prostate CancerNCT04062162
Walking Football as a Supportive Medicine for Patients With Prostate Cancer
A study testing Walking football training in people with Prostate Cancer and Androgen Deprivation Therapy, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
Trial summary
Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Androgen Deprivation Therapy
- What is being tested?
- Walking football training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Jul 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with PCa
- Under castration therapy for more than 3 months
- Planned to be under castration for more than 6 months
- Follow-up at the Medical Oncology department and/or Urology department of the Hospital Center Vila Nova de Gaia/Espinho.
Who cannot join
- Medical or surgical contraindications for exercise.
- T-score < -2.5
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia
About this study
Official title: Is the Walking Football a Feasible Approach to Improve Health-related Quality of Life in Men With Prostate Cancer Receiving Androgen Deprivation Therapy? the PROSTATA_MOVE Randomized Controlled Trial.
Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Exercise has been proposed as a non-pharmacological strategy to counter some adverse effects of ADT among patients with PCa. Particularly, recreational football-based interventions have been suggested as an enjoyment approach to involve patients with PCa in regular exercise practice. Given its intermittent nature and vigorous efforts, adverse events associated with recreational football practice have been reported. To handle this issue and to involve patients with PCa in recreational football practice, walking football has emerged as a more suitable exercise modality
Read the detailed description
This study was design as a randomized controlled trial, with two study arms, which aims to analyse the feasibility, safety of a supervised walking football program in patients with PCa. Moreover, the effects on health-related quality of life; bone mineral density; body composition; physical fitness; physical activity levels; inflammatory and metabolic profile; cognitive function; and cost-effectiveness will be complementarily analysed.
Recruitment will be conducted by invitation of Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E; Vila Nova de Gaia, Portugal, E.P.E) oncologists and urologists. Patients who agree to participate in this study will be referred to a study coordinator (medical oncologist) and will be randomly allocated (1:1 ratio) to one of the two study-arms.
In addition to standard PCa care, patients in the interventional group (IG) will perform 3 times per week a supervised Walking Football Program over 16 weeks and plus 16 additional weeks.
Patients allocated to control group (CG) will receive standard PCa medical care and will be instructed to maintain daily-life routines. After the first 16 weeks, the control group patients' will be invited to join and preform the exercise intervention (additional 16 weeks).
Walking football exercise sessions will be conducted on an indoor sports hall, supervised by one exercise physiologist and a football coach. Exercise intensity will be monitored through heart rate and rated perceived exertion.
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy
- Being tested
- Walking football training
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Walking football
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking football trainingBehavioural
Also called Exercise training
Intervention will involve 3 sessions per week of a structured and supervised walking football program over 16 weeks. Each session will include a warm-up, followed by the practice of specific exercises where specific technical skills (pass, dribble, shot), motor skills (agility, coordination, balance) and physical fitness (cardiorespiratory and musculoskeletal capacity) will be enhanced, ending with a structured game (7x7) of walking football and a cooldown.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Active comparator | Walking football training Receives: Behavioral: Walking football training |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate.
Assessed by the number of enrolled patients divided by the number of invited patients.
Measured: Baseline
Withdrawal rate
Assessed by the number of withdrawal patients
Measured: Change from baseline to 32 weeks
Appropriateness of outcomes assessments.
Assessed by the percentage of completed data.
Measured: Change from baseline to 32 weeks
Adherence to intervention.
Assessed by the number of completed sessions and the number of missed sessions.
Measured: Change from baseline to 32 weeks
Rate of Enjoyment
Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points).
Measured: Change from baseline to 32 weeks
Health-related quality of life
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Measured: Change from baseline to 32 weeks
Secondary outcomes (29)
Bone Mineral Density
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Measured: Change from baseline to 32 weeks
Body composition
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Measured: Change from baseline to 32 weeks
Aerobic capacity
Assessed by a symptom-limited exercise test on a treadmill
Measured: Change from baseline to 32 weeks
Maximal isometric handgrip strength
Assessed using a digital handgrip dynamometer.
Measured: Change from baseline to 32 weeks
Maximal isometric lower limb strength
Assessed using a digital handgrip dynamometer.
Measured: Change from baseline to 32 weeks
Lower limb functionality
Assessed by the 30-seconds sit-to-stand test
Measured: Change from baseline to 32 weeks
Static balance
Assessed by the single leg stance test
Measured: Change from baseline to 32 weeks
Habitual physical activity levels
Assessed using accelerometers
Measured: Change from baseline to 32 weeks
Exercise intensity - External load
Distance (km) assessed using GPS tracking during exercise
Measured: Change from baseline to 32 weeks
Exercise intensity - Internal load
Assessed by the heart rate
Measured: Change from baseline to 32 weeks
Exercise intensity - Rating of perceived exertion
Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).
Measured: Change from baseline to 32 weeks
Cogntive function
Assessed by the Montreal Cognitive Assessment
Measured: Change from baseline to 32 weeks
Blood pressure
Assessed using a digital sphygmomanometer
Measured: Change from baseline to 32 weeks
Resting heart rate
Assessed using a digital sphygmomanometer
Measured: Change from baseline to 32 weeks
LDL-cholesterol
Blood sample will be taken for analysis of levels of LDL-cholesterol
Measured: Change from baseline to 32 weeks
HDL-cholesterol
Blood sample will be taken for analysis of levels of HDL-cholesterol
Measured: Change from baseline to 32 weeks
Total cholesterol
Blood sample will be taken for analysis of levels of total cholesterol
Measured: Change from baseline to 32 weeks
Triglycerides
Blood sample will be taken for analysis of levels of triglycerides
Measured: Change from baseline to 32 weeks
Prostate specific antigen (PSA)
Blood sample will be taken for analysis of levels of PSA
Measured: Change from baseline to 32 weeks
Creatinine
Blood sample will be taken for analysis of levels of creatinine
Measured: Change from baseline to 32 weeks
High sensitivity C-reactive protein (HS-CRP)
Blood sample will be taken for analysis of levels of HS-CRP
Measured: Change from baseline to 32 weeks
N-terminal type B natriuretic peptide (NT-proBNP)
Blood sample will be taken for analysis of levels of NT-proBNP
Measured: Change from baseline to 32 weeks
Vitamin D
Blood sample will be taken for analysis of levels of vitamin D
Measured: Change from baseline to 32 weeks
Osteocalcin
Blood sample will be taken for analysis of levels of
Measured: Change from baseline to 32 weeks
C-Telopeptide of Collagen Cross-links (CTx)
Blood sample will be taken for analysis of levels of CTx
Measured: Change from baseline to 32 weeks
Bone Specific Alkaline Phosphatase (BSAP)
Blood sample will be taken for analysis of levels of BSAP
Measured: Change from baseline to 32 weeks
Tartrate-Resistant Acid Phosphatase (TRAP)
Blood sample will be taken for analysis of levels of TRAP
Measured: Change from baseline to 32 weeks
Glycated hemoglobin
Blood sample will be taken for analysis of levels of glycated hemoglobin
Measured: Change from baseline to 32 weeks
Testosterone
Blood sample will be taken for analysis of levels of testosterone
Measured: Change from baseline to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start11 Jul 2019
- Primary completion31 May 2020 (estimated)
- Study completion30 Jun 2020 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University of Beira Interior, Portuguese Football Federation, University Institute of Maia, Câmara Municipal de Gaia
- Responsible party
- Principal investigator, Andreia Capela, Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Investigators
- Andreia Capela, MD, Principal investigator, Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062162
- Sponsor's protocol ID
- AICSO
- Status last verified
- Jan 2020
- First submitted
- 8 Aug 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capela A, Antunes P, Coelho CA, Garcia CL, Custodio S, Amorim R, Costa T, Vilela E, Teixeira M, Amarelo A, Silva J, Joaquim A, Viamonte S, Brito J, Alves AJ. Effects of walking football on adherence, safety, quality of life and physical fitness in patients with prostate cancer: Findings from the PROSTATA_MOVE randomized controlled trial. Front Oncol. 2023 Mar 21;13:1129028. doi: 10.3389/fonc.2023.1129028. eCollection 2023.
PubMed 37025594
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Walking Football a Feasible Approach to Improve Health-related Quality of Life in Men With Prostate Cancer Receiving Androgen Deprivation Therapy? the PROSTATA_MOVE Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04062162
- Acronym / sponsor ID
- AICSO
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Walking football
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University of Beira Interior, Portuguese Football Federation, University Institute of Maia, Câmara Municipal de Gaia
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 Aug 2019 (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.
Androgen deprivation therapy (ADT) is widely used in men with prostate cancer (PCa) to delay disease progression and enhance survival. The use of ADT is often associated with a vast spectrum of side effects that considerably reduce quality of life. Exercise has been proposed as a non-pharmacological strategy to counter some adverse effects of ADT among patients with PCa. Particularly, recreational football-based interventions have been suggested as an enjoyment approach to involve patients with PCa in regular exercise practice. Given its intermittent nature and vigorous efforts, adverse events associated with recreational football practice have been reported. To handle this issue and to involve patients with PCa in recreational football practice, walking football has emerged as a more suitable exercise modality
Detailed description
This study was design as a randomized controlled trial, with two study arms, which aims to analyse the feasibility, safety of a supervised walking football program in patients with PCa. Moreover, the effects on health-related quality of life; bone mineral density; body composition; physical fitness; physical activity levels; inflammatory and metabolic profile; cognitive function; and cost-effectiveness will be complementarily analysed.
Recruitment will be conducted by invitation of Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E; Vila Nova de Gaia, Portugal, E.P.E) oncologists and urologists. Patients who agree to participate in this study will be referred to a study coordinator (medical oncologist) and will be randomly allocated (1:1 ratio) to one of the two study-arms.
In addition to standard PCa care, patients in the interventional group (IG) will perform 3 times per week a supervised Walking Football Program over 16 weeks and plus 16 additional weeks.
Patients allocated to control group (CG) will receive standard PCa medical care and will be instructed to maintain daily-life routines. After the first 16 weeks, the control group patients' will be invited to join and preform the exercise intervention (additional 16 weeks).
Walking football exercise sessions will be conducted on an indoor sports hall, supervised by one exercise physiologist and a football coach. Exercise intensity will be monitored through heart rate and rated perceived exertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Active comparator | Behavioral: Walking football trainingWalking football training |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with PCa
- Under castration therapy for more than 3 months
- Planned to be under castration for more than 6 months
- Follow-up at the Medical Oncology department and/or Urology department of the Hospital Center Vila Nova de Gaia/Espinho.
Key exclusion criteria (2 listed)
- Medical or surgical contraindications for exercise.
- T-score < -2.5
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 |
|---|---|---|
| Walking football trainingAlso: Exercise trainingIntervention will involve 3 sessions per week of a structured and supervised walking football program over 16 weeks. Each session will include a warm-up, followed by the practice of specific exercises where specific technical skills (pass, dribble, shot), motor skills (agility, coordination, balance) and physical fitness (cardiorespiratory and musculoskeletal capacity) will be enhanced, ending with a structured game (7x7) of walking football and a cooldown. | Behavioural | Interventional group |
Primary outcome
Recruitment rate.
Time frame: Baseline
Assessed by the number of enrolled patients divided by the number of invited patients.
Withdrawal rate
Time frame: Change from baseline to 32 weeks
Assessed by the number of withdrawal patients
Appropriateness of outcomes assessments.
Time frame: Change from baseline to 32 weeks
Assessed by the percentage of completed data.
Adherence to intervention.
Time frame: Change from baseline to 32 weeks
Assessed by the number of completed sessions and the number of missed sessions.
Rate of Enjoyment
Time frame: Change from baseline to 32 weeks
Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points).
Health-related quality of life
Time frame: Change from baseline to 32 weeks
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
29 secondary outcomes
Bone Mineral Density
Time frame: Change from baseline to 32 weeks
Body composition
Time frame: Change from baseline to 32 weeks
Aerobic capacity
Time frame: Change from baseline to 32 weeks
Maximal isometric handgrip strength
Time frame: Change from baseline to 32 weeks
Maximal isometric lower limb strength
Time frame: Change from baseline to 32 weeks
Lower limb functionality
Time frame: Change from baseline to 32 weeks
Static balance
Time frame: Change from baseline to 32 weeks
Habitual physical activity levels
Time frame: Change from baseline to 32 weeks
Exercise intensity - External load
Time frame: Change from baseline to 32 weeks
Exercise intensity - Internal load
Time frame: Change from baseline to 32 weeks
Exercise intensity - Rating of perceived exertion
Time frame: Change from baseline to 32 weeks
Cogntive function
Time frame: Change from baseline to 32 weeks
Blood pressure
Time frame: Change from baseline to 32 weeks
Resting heart rate
Time frame: Change from baseline to 32 weeks
LDL-cholesterol
Time frame: Change from baseline to 32 weeks
HDL-cholesterol
Time frame: Change from baseline to 32 weeks
Total cholesterol
Time frame: Change from baseline to 32 weeks
Triglycerides
Time frame: Change from baseline to 32 weeks
Prostate specific antigen (PSA)
Time frame: Change from baseline to 32 weeks
Creatinine
Time frame: Change from baseline to 32 weeks
High sensitivity C-reactive protein (HS-CRP)
Time frame: Change from baseline to 32 weeks
N-terminal type B natriuretic peptide (NT-proBNP)
Time frame: Change from baseline to 32 weeks
Vitamin D
Time frame: Change from baseline to 32 weeks
Osteocalcin
Time frame: Change from baseline to 32 weeks
C-Telopeptide of Collagen Cross-links (CTx)
Time frame: Change from baseline to 32 weeks
Bone Specific Alkaline Phosphatase (BSAP)
Time frame: Change from baseline to 32 weeks
Tartrate-Resistant Acid Phosphatase (TRAP)
Time frame: Change from baseline to 32 weeks
Glycated hemoglobin
Time frame: Change from baseline to 32 weeks
Testosterone
Time frame: Change from baseline to 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 37025594Capela A, Antunes P, Coelho CA, Garcia CL, Custodio S, Amorim R, Costa T, Vilela E, Teixeira M, Amarelo A, Silva J, Joaquim A, Viamonte S, Brito J, Alves AJ. Effects of walking football on adherence, safety, quality of life and physical fitness in patients with prostate cancer: Findings from the PROSTATA_MOVE randomized controlled trial. Front Oncol. 2023 Mar 21;13:1129028. doi: 10.3389/fonc.2023.1129028. eCollection 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andreia Capela, MD principal investigator
Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking football training in people with Prostate Cancer and Androgen Deprivation Therapy, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate. (time frame: Baseline). The study lists 6 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 NCT04062162, 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 13 Jan 2020.