Walking Football as a Supportive Medicine for Patients With Prostate Cancer

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

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer; Androgen Deprivation Therapy
• Intervention / Treatment: Behavioral: Walking football training

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Vila Nova de Gaia, Portugal
    • Centro Hospitalar Vila Nova de Gaia / Espinho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
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 Names: Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.	Change from baseline to 32 weeks
Body composition	Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.	Change from baseline to 32 weeks
Aerobic capacity	Assessed by a symptom-limited exercise test on a treadmill	Change from baseline to 32 weeks
Maximal isometric handgrip strength	Assessed using a digital handgrip dynamometer.	Change from baseline to 32 weeks
Maximal isometric lower limb strength	Assessed using a digital handgrip dynamometer.	Change from baseline to 32 weeks
Lower limb functionality	Assessed by the 30-seconds sit-to-stand test	Change from baseline to 32 weeks
Static balance	Assessed by the single leg stance test	Change from baseline to 32 weeks
Habitual physical activity levels	Assessed using accelerometers	Change from baseline to 32 weeks
Exercise intensity - External load	Distance (km) assessed using GPS tracking during exercise	Change from baseline to 32 weeks
Exercise intensity - Internal load	Assessed by the heart rate	Change from baseline to 32 weeks
Exercise intensity - Rating of perceived exertion	Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).	Change from baseline to 32 weeks
Cogntive function	Assessed by the Montreal Cognitive Assessment	Change from baseline to 32 weeks
Blood pressure	Assessed using a digital sphygmomanometer	Change from baseline to 32 weeks
Resting heart rate	Assessed using a digital sphygmomanometer	Change from baseline to 32 weeks
LDL-cholesterol	Blood sample will be taken for analysis of levels of LDL-cholesterol	Change from baseline to 32 weeks
HDL-cholesterol	Blood sample will be taken for analysis of levels of HDL-cholesterol	Change from baseline to 32 weeks
Total cholesterol	Blood sample will be taken for analysis of levels of total cholesterol	Change from baseline to 32 weeks
Triglycerides	Blood sample will be taken for analysis of levels of triglycerides	Change from baseline to 32 weeks
Prostate specific antigen (PSA)	Blood sample will be taken for analysis of levels of PSA	Change from baseline to 32 weeks
Creatinine	Blood sample will be taken for analysis of levels of creatinine	Change from baseline to 32 weeks
High sensitivity C-reactive protein (HS-CRP)	Blood sample will be taken for analysis of levels of HS-CRP	Change from baseline to 32 weeks
N-terminal type B natriuretic peptide (NT-proBNP)	Blood sample will be taken for analysis of levels of NT-proBNP	Change from baseline to 32 weeks
Vitamin D	Blood sample will be taken for analysis of levels of vitamin D	Change from baseline to 32 weeks
Osteocalcin	Blood sample will be taken for analysis of levels of	Change from baseline to 32 weeks
C-Telopeptide of Collagen Cross-links (CTx)	Blood sample will be taken for analysis of levels of CTx	Change from baseline to 32 weeks
Bone Specific Alkaline Phosphatase (BSAP)	Blood sample will be taken for analysis of levels of BSAP	Change from baseline to 32 weeks
Tartrate-Resistant Acid Phosphatase (TRAP)	Blood sample will be taken for analysis of levels of TRAP	Change from baseline to 32 weeks
Glycated hemoglobin	Blood sample will be taken for analysis of levels of glycated hemoglobin	Change from baseline to 32 weeks
Testosterone	Blood sample will be taken for analysis of levels of testosterone	Change from baseline to 32 weeks

Collaborators and Investigators

• Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Collaborators: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.; University Institute of Maia; University of Beira Interior; Federação Portuguesa de Futebol; Câmara Municipal de Gaia
• Investigators: Principal Investigator: Andreia Capela, MD, Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 18, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Prostate Cancer; Androgen Deprivation Therapy; Walking football
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AICSO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No