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Walking Football as a Supportive Medicine for Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04062162
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University of Beira Interior
Federação Portuguesa de Futebol
University Institute of Maia
Câmara Municipal de Gaia
Information provided by (Responsible Party):
Andreia Capela, Associacao de Investigacao de Cuidados de Suporte em Oncologia

Brief 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. 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

Condition or disease Intervention/treatment Phase
Prostate Cancer Androgen Deprivation Therapy Behavioral: Walking football training Not Applicable

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 two exercise physiologists. Exercise intensity will be monitored through heart rate and rated perceived exertion.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Exercise training

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. Recruitment rate. [ Time Frame: Baseline ]
    Assessed by the number of enrolled patients divided by the number of invited patients.

  2. Withdrawal rate [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the number of withdrawal patients

  3. Appropriateness of outcomes assessments. [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the percentage of completed data.

  4. Adherence to intervention. [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the number of completed sessions and the number of missed sessions.

  5. 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).

  6. Health-related quality of life [ Time Frame: Change from baseline to 32 weeks ]
    Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.


Secondary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.

  2. Body composition [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.

  3. Aerobic capacity [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by a symptom-limited exercise test on a treadmill

  4. Maximal isometric handgrip strength [ Time Frame: Change from baseline to 32 weeks ]
    Assessed using a digital handgrip dynamometer.

  5. Maximal isometric lower limb strength [ Time Frame: Change from baseline to 32 weeks ]
    Assessed using a digital handgrip dynamometer.

  6. Lower limb functionality [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the 30-seconds sit-to-stand test

  7. Static balance [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the single leg stance test

  8. Habitual physical activity levels [ Time Frame: Change from baseline to 32 weeks ]
    Assessed using accelerometers

  9. Exercise intensity - External load [ Time Frame: Change from baseline to 32 weeks ]
    Distance (km) assessed using GPS tracking during exercise

  10. Exercise intensity - Internal load [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the heart rate

  11. 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).

  12. Cogntive function [ Time Frame: Change from baseline to 32 weeks ]
    Assessed by the Montreal Cognitive Assessment

  13. Blood pressure [ Time Frame: Change from baseline to 32 weeks ]
    Assessed using a digital sphygmomanometer

  14. Resting heart rate [ Time Frame: Change from baseline to 32 weeks ]
    Assessed using a digital sphygmomanometer

  15. LDL-cholesterol [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of LDL-cholesterol

  16. HDL-cholesterol [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of HDL-cholesterol

  17. Total cholesterol [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of total cholesterol

  18. Triglycerides [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of triglycerides

  19. Prostate specific antigen (PSA) [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of PSA

  20. Creatinine [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of creatinine

  21. 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

  22. 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

  23. Vitamin D [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of vitamin D

  24. Osteocalcin [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of

  25. 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

  26. Bone Specific Alkaline Phosphatase (BSAP) [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of BSAP

  27. Tartrate-Resistant Acid Phosphatase (TRAP) [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of TRAP

  28. Glycated hemoglobin [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of glycated hemoglobin

  29. Testosterone [ Time Frame: Change from baseline to 32 weeks ]
    Blood sample will be taken for analysis of levels of testosterone



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062162


Contacts
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Contact: Andreia Capela, MD 00351917163485 andreia.capela@gmail.com
Contact: Pedro Antunes, MsC 00351969270946 pantunes_14@hotmail.com

Locations
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Portugal
Centro Hospitalar Vila Nova de Gaia / Espinho Recruiting
Vila Nova de Gaia, Portugal
Contact: Andreia Capela, MD         
Contact: Pedro Antunes, MSc         
Sub-Investigator: Pedro Antunes, MSc         
Sub-Investigator: Sandra Custódio, MD         
Sub-Investigator: Telma Costa, MD         
Sub-Investigator: António Moreira Pinto, MD         
Sub-Investigator: Rui Amorim, MD         
Sub-Investigator: Luis Ferraz, MD         
Sub-Investigator: Eduardo Vilela, MD         
Sub-Investigator: Madalena Teixeira, MD         
Sub-Investigator: Sofia Viamonte, MD         
Sub-Investigator: Rui Cadilha, MD         
Sub-Investigator: Sofia Florim, MD         
Sub-Investigator: Alberto Alves, PhD         
Sub-Investigator: João Brito, PhD         
Sub-Investigator: André Coelho         
Sub-Investigator: Bruno Travassos, PhD         
Sub-Investigator: Anabela Amarelo         
Sub-Investigator: Joana Silva         
Sub-Investigator: Judite Pacheco         
Sub-Investigator: Ana João Tavares         
Sub-Investigator: Ana Joaquim, MD         
Sub-Investigator: Romeu Mendes, PhD         
Sponsors and Collaborators
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University of Beira Interior
Federação Portuguesa de Futebol
University Institute of Maia
Câmara Municipal de Gaia
Investigators
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Principal Investigator: Andreia Capela, MD Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

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Responsible Party: Andreia Capela, Medical oncologist at Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., Associacao de Investigacao de Cuidados de Suporte em Oncologia
ClinicalTrials.gov Identifier: NCT04062162     History of Changes
Other Study ID Numbers: AICSO
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreia Capela, Associacao de Investigacao de Cuidados de Suporte em Oncologia:
Prostate Cancer
Androgen Deprivation Therapy
Walking football
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs