Clinical trial NCT04062162: Walking Football as a Supportive Medicine for Patients With Prostate Cancer
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Androgen Deprivation Therapy
Keywords: Prostate Cancer
Androgen Deprivation Therapy
Walking football
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: University of Beira Interior
name: Federação Portuguesa de Futebol
name: University Institute of Maia
name: Câmara Municipal de Gaia
First posted: 2019-08-20
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Recruitment rate.
timeFrame: Baseline
measure: Withdrawal rate
timeFrame: Change from baseline to 32 weeks
measure: Appropriateness of outcomes assessments.
timeFrame: Change from baseline to 32 weeks
measure: Adherence to intervention.
timeFrame: Change from baseline to 32 weeks
measure: Rate of Enjoyment
timeFrame: Change from baseline to 32 weeks
measure: Health-related quality of life
timeFrame: Change from baseline to 32 weeks
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: Change from baseline to 32 weeks
measure: Body composition
timeFrame: Change from baseline to 32 weeks
measure: Aerobic capacity
timeFrame: Change from baseline to 32 weeks
measure: Maximal isometric handgrip strength
timeFrame: Change from baseline to 32 weeks
measure: Maximal isometric lower limb strength
timeFrame: Change from baseline to 32 weeks
measure: Lower limb functionality
timeFrame: Change from baseline to 32 weeks
measure: Static balance
timeFrame: Change from baseline to 32 weeks
measure: Habitual physical activity levels
timeFrame: Change from baseline to 32 weeks
measure: Exercise intensity - External load
timeFrame: Change from baseline to 32 weeks
measure: Exercise intensity - Internal load
timeFrame: Change from baseline to 32 weeks
measure: Exercise intensity - Rating of perceived exertion
timeFrame: Change from baseline to 32 weeks
measure: Cogntive function
timeFrame: Change from baseline to 32 weeks
measure: Blood pressure
timeFrame: Change from baseline to 32 weeks
measure: Resting heart rate
timeFrame: Change from baseline to 32 weeks
measure: LDL-cholesterol
timeFrame: Change from baseline to 32 weeks
measure: HDL-cholesterol
timeFrame: Change from baseline to 32 weeks
measure: Total cholesterol
timeFrame: Change from baseline to 32 weeks
measure: Triglycerides
timeFrame: Change from baseline to 32 weeks
measure: Prostate specific antigen (PSA)
timeFrame: Change from baseline to 32 weeks
measure: Creatinine
timeFrame: Change from baseline to 32 weeks
measure: High sensitivity C-reactive protein (HS-CRP)
timeFrame: Change from baseline to 32 weeks
measure: N-terminal type B natriuretic peptide (NT-proBNP)
timeFrame: Change from baseline to 32 weeks
measure: Vitamin D
timeFrame: Change from baseline to 32 weeks
measure: Osteocalcin
timeFrame: Change from baseline to 32 weeks
measure: C-Telopeptide of Collagen Cross-links (CTx)
timeFrame: Change from baseline to 32 weeks
measure: Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: Change from baseline to 32 weeks
measure: Tartrate-Resistant Acid Phosphatase (TRAP)
timeFrame: Change from baseline to 32 weeks
measure: Glycated hemoglobin
timeFrame: Change from baseline to 32 weeks
measure: Testosterone
timeFrame: Change from baseline to 32 weeks
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia / Espinho
Study officials:
affiliation: Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
name: Andreia Capela, MD
role: PRINCIPAL_INVESTIGATOR
References: