Walking Football as a Supportive Medicine for Patients With Prostate Cancer

NCT04062162 | Unknown

• 1 other identifier: AICSO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer; Androgen Deprivation Therapy

Keywords

Prostate Cancer; Androgen Deprivation Therapy; Walking football

Outcome Measures

Primary Outcomes (6)

• Recruitment rate.

  Assessed by the number of enrolled patients divided by the number of invited patients.

  Baseline

• Withdrawal rate

  Assessed by the number of withdrawal patients

  Change from baseline to 32 weeks

• Appropriateness of outcomes assessments.

  Assessed by the percentage of completed data.

  Change from baseline to 32 weeks

• Adherence to intervention.

  Assessed by the number of completed sessions and the number of missed sessions.

  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).

  Change from baseline to 32 weeks

• Health-related quality of life

  Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.

  Change from baseline to 32 weeks

Secondary Outcomes (29)

• Bone Mineral Density

  Change from baseline to 32 weeks

• Body composition

  Change from baseline to 32 weeks

• Aerobic capacity

  Change from baseline to 32 weeks

• Maximal isometric handgrip strength

  Change from baseline to 32 weeks

• Maximal isometric lower limb strength

  Change from baseline to 32 weeks

Study Arms (2)

Interventional group

ACTIVE COMPARATOR

Walking football training

Behavioral: Walking football training

Control group

NO INTERVENTION

Usual care

Interventions

Walking football training BEHAVIORAL

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.

Also known as: Exercise training

Interventional group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Associacao de Investigacao de Cuidados de Suporte em Oncologia: lead
• Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.: collaborator
• University of Beira Interior: collaborator
• Federação Portuguesa de Futebol: collaborator
• University Institute of Maia: collaborator
• Câmara Municipal de Gaia: collaborator

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia / Espinho

Vila Nova de Gaia, Portugal

Location

Related Publications (1)

• 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.

  PMID: 37025594 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andreia Capela, MD

  Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical oncologist at Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 20, 2019
• Study Start: July 11, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)