Walking Football as a Supportive Medicine for Patients With Prostate Cancer

January 9, 2020 updated by: Andreia Capela, Associacao de Investigacao de Cuidados de Suporte em Oncologia

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar Vila Nova de Gaia / Espinho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Medical or surgical contraindications for exercise.
  • T-score < -2.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Usual care
Active Comparator: Interventional group
Walking football training
Behavioral: Walking football 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.
Other Names:
  • Exercise training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate.
Time Frame: Baseline
Assessed by the number of enrolled patients divided by the number of invited patients.
Baseline
Withdrawal rate
Time Frame: Change from baseline to 32 weeks
Assessed by the number of withdrawal patients
Change from baseline to 32 weeks
Appropriateness of outcomes assessments.
Time Frame: Change from baseline to 32 weeks
Assessed by the percentage of completed data.
Change from baseline to 32 weeks
Adherence to intervention.
Time Frame: Change from baseline to 32 weeks
Assessed by the number of completed sessions and the number of missed sessions.
Change from baseline to 32 weeks
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).
Change from baseline to 32 weeks
Health-related quality of life
Time Frame: Change from baseline to 32 weeks
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Change from baseline to 32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
Time Frame: Change from baseline to 32 weeks
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Change from baseline to 32 weeks
Body composition
Time Frame: Change from baseline to 32 weeks
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Change from baseline to 32 weeks
Aerobic capacity
Time Frame: Change from baseline to 32 weeks
Assessed by a symptom-limited exercise test on a treadmill
Change from baseline to 32 weeks
Maximal isometric handgrip strength
Time Frame: Change from baseline to 32 weeks
Assessed using a digital handgrip dynamometer.
Change from baseline to 32 weeks
Maximal isometric lower limb strength
Time Frame: Change from baseline to 32 weeks
Assessed using a digital handgrip dynamometer.
Change from baseline to 32 weeks
Lower limb functionality
Time Frame: Change from baseline to 32 weeks
Assessed by the 30-seconds sit-to-stand test
Change from baseline to 32 weeks
Static balance
Time Frame: Change from baseline to 32 weeks
Assessed by the single leg stance test
Change from baseline to 32 weeks
Habitual physical activity levels
Time Frame: Change from baseline to 32 weeks
Assessed using accelerometers
Change from baseline to 32 weeks
Exercise intensity - External load
Time Frame: Change from baseline to 32 weeks
Distance (km) assessed using GPS tracking during exercise
Change from baseline to 32 weeks
Exercise intensity - Internal load
Time Frame: Change from baseline to 32 weeks
Assessed by the heart rate
Change from baseline to 32 weeks
Exercise intensity - Rating of perceived exertion
Time Frame: Change from baseline to 32 weeks
Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).
Change from baseline to 32 weeks
Cogntive function
Time Frame: Change from baseline to 32 weeks
Assessed by the Montreal Cognitive Assessment
Change from baseline to 32 weeks
Blood pressure
Time Frame: Change from baseline to 32 weeks
Assessed using a digital sphygmomanometer
Change from baseline to 32 weeks
Resting heart rate
Time Frame: Change from baseline to 32 weeks
Assessed using a digital sphygmomanometer
Change from baseline to 32 weeks
LDL-cholesterol
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of LDL-cholesterol
Change from baseline to 32 weeks
HDL-cholesterol
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of HDL-cholesterol
Change from baseline to 32 weeks
Total cholesterol
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of total cholesterol
Change from baseline to 32 weeks
Triglycerides
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of triglycerides
Change from baseline to 32 weeks
Prostate specific antigen (PSA)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of PSA
Change from baseline to 32 weeks
Creatinine
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of creatinine
Change from baseline to 32 weeks
High sensitivity C-reactive protein (HS-CRP)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of HS-CRP
Change from baseline to 32 weeks
N-terminal type B natriuretic peptide (NT-proBNP)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of NT-proBNP
Change from baseline to 32 weeks
Vitamin D
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of vitamin D
Change from baseline to 32 weeks
Osteocalcin
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of
Change from baseline to 32 weeks
C-Telopeptide of Collagen Cross-links (CTx)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of CTx
Change from baseline to 32 weeks
Bone Specific Alkaline Phosphatase (BSAP)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of BSAP
Change from baseline to 32 weeks
Tartrate-Resistant Acid Phosphatase (TRAP)
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of TRAP
Change from baseline to 32 weeks
Glycated hemoglobin
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of glycated hemoglobin
Change from baseline to 32 weeks
Testosterone
Time Frame: Change from baseline to 32 weeks
Blood sample will be taken for analysis of levels of testosterone
Change from baseline to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Associacao de Investigacao de Cuidados de Suporte em Oncologia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University Institute of Maia
University of Beira Interior
Federação Portuguesa de Futebol
Câmara Municipal de Gaia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreia Capela, MD, Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AICSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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