Prostate Cancer Clinical Trial
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
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.
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