Walking Football as a Supportive Medicine for Patients With Prostate Cancer

NCT ID: NCT04062162

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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Prostate Cancer Androgen Deprivation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interventional group

Walking football training

Group Type ACTIVE_COMPARATOR

Walking football training

Intervention Type 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.

Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Exercise training

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

OTHER_GOV

Sponsor Role collaborator

University of Beira Interior

OTHER

Sponsor Role collaborator

Federação Portuguesa de Futebol

UNKNOWN

Sponsor Role collaborator

University Institute of Maia

OTHER

Sponsor Role collaborator

Câmara Municipal de Gaia

UNKNOWN

Sponsor Role collaborator

Associacao de Investigacao de Cuidados de Suporte em Oncologia

OTHER

Sponsor Role lead

Responsible Party

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Andreia Capela

Medical oncologist at Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreia Capela, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

Locations

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Centro Hospitalar Vila Nova de Gaia / Espinho

Vila Nova de Gaia, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 37025594 (View on PubMed)

Other Identifiers

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AICSO

Identifier Type: -

Identifier Source: org_study_id

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