Walking Football as a Supportive Medicine for Patients With Prostate Cancer
Primary Purpose
Prostate Cancer, Androgen Deprivation Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Walking football training
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen Deprivation Therapy, Walking football
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
Sites / Locations
- Centro Hospitalar Vila Nova de Gaia / Espinho
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Walking football training
Usual care
Outcomes
Primary Outcome Measures
Recruitment rate.
Assessed by the number of enrolled patients divided by the number of invited patients.
Withdrawal rate
Assessed by the number of withdrawal patients
Appropriateness of outcomes assessments.
Assessed by the percentage of completed data.
Adherence to intervention.
Assessed by the number of completed sessions and the number of missed sessions.
Rate of Enjoyment
Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points).
Health-related quality of life
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Secondary Outcome Measures
Bone Mineral Density
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Body composition
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Aerobic capacity
Assessed by a symptom-limited exercise test on a treadmill
Maximal isometric handgrip strength
Assessed using a digital handgrip dynamometer.
Maximal isometric lower limb strength
Assessed using a digital handgrip dynamometer.
Lower limb functionality
Assessed by the 30-seconds sit-to-stand test
Static balance
Assessed by the single leg stance test
Habitual physical activity levels
Assessed using accelerometers
Exercise intensity - External load
Distance (km) assessed using GPS tracking during exercise
Exercise intensity - Internal load
Assessed by the heart rate
Exercise intensity - Rating of perceived exertion
Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).
Cogntive function
Assessed by the Montreal Cognitive Assessment
Blood pressure
Assessed using a digital sphygmomanometer
Resting heart rate
Assessed using a digital sphygmomanometer
LDL-cholesterol
Blood sample will be taken for analysis of levels of LDL-cholesterol
HDL-cholesterol
Blood sample will be taken for analysis of levels of HDL-cholesterol
Total cholesterol
Blood sample will be taken for analysis of levels of total cholesterol
Triglycerides
Blood sample will be taken for analysis of levels of triglycerides
Prostate specific antigen (PSA)
Blood sample will be taken for analysis of levels of PSA
Creatinine
Blood sample will be taken for analysis of levels of creatinine
High sensitivity C-reactive protein (HS-CRP)
Blood sample will be taken for analysis of levels of HS-CRP
N-terminal type B natriuretic peptide (NT-proBNP)
Blood sample will be taken for analysis of levels of NT-proBNP
Vitamin D
Blood sample will be taken for analysis of levels of vitamin D
Osteocalcin
Blood sample will be taken for analysis of levels of
C-Telopeptide of Collagen Cross-links (CTx)
Blood sample will be taken for analysis of levels of CTx
Bone Specific Alkaline Phosphatase (BSAP)
Blood sample will be taken for analysis of levels of BSAP
Tartrate-Resistant Acid Phosphatase (TRAP)
Blood sample will be taken for analysis of levels of TRAP
Glycated hemoglobin
Blood sample will be taken for analysis of levels of glycated hemoglobin
Testosterone
Blood sample will be taken for analysis of levels of testosterone
Full Information
NCT ID
NCT04062162
First Posted
August 8, 2019
Last Updated
January 9, 2020
Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University of Beira Interior, Federação Portuguesa de Futebol, University Institute of Maia, Câmara Municipal de Gaia
1. Study Identification
Unique Protocol Identification Number
NCT04062162
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University of Beira Interior, Federação Portuguesa de Futebol, University Institute of Maia, Câmara Municipal de Gaia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Androgen Deprivation Therapy
Keywords
Prostate Cancer, Androgen Deprivation Therapy, Walking football
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Active Comparator
Arm Description
Walking football training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Walking football training
Other Intervention Name(s)
Exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate.
Description
Assessed by the number of enrolled patients divided by the number of invited patients.
Time Frame
Baseline
Title
Withdrawal rate
Description
Assessed by the number of withdrawal patients
Time Frame
Change from baseline to 32 weeks
Title
Appropriateness of outcomes assessments.
Description
Assessed by the percentage of completed data.
Time Frame
Change from baseline to 32 weeks
Title
Adherence to intervention.
Description
Assessed by the number of completed sessions and the number of missed sessions.
Time Frame
Change from baseline to 32 weeks
Title
Rate of Enjoyment
Description
Assessed by the self-reported exercise sessions' enjoyment using a likert scale (1 [lowest] to 5 [highest] points).
Time Frame
Change from baseline to 32 weeks
Title
Health-related quality of life
Description
Using EORTC PR25, EQ-5D-5L and SF-6D questionnaire.
Time Frame
Change from baseline to 32 weeks
Secondary Outcome Measure Information:
Title
Bone Mineral Density
Description
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Change from baseline to 32 weeks
Title
Body composition
Description
Assessed by a whole-body dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
Change from baseline to 32 weeks
Title
Aerobic capacity
Description
Assessed by a symptom-limited exercise test on a treadmill
Time Frame
Change from baseline to 32 weeks
Title
Maximal isometric handgrip strength
Description
Assessed using a digital handgrip dynamometer.
Time Frame
Change from baseline to 32 weeks
Title
Maximal isometric lower limb strength
Description
Assessed using a digital handgrip dynamometer.
Time Frame
Change from baseline to 32 weeks
Title
Lower limb functionality
Description
Assessed by the 30-seconds sit-to-stand test
Time Frame
Change from baseline to 32 weeks
Title
Static balance
Description
Assessed by the single leg stance test
Time Frame
Change from baseline to 32 weeks
Title
Habitual physical activity levels
Description
Assessed using accelerometers
Time Frame
Change from baseline to 32 weeks
Title
Exercise intensity - External load
Description
Distance (km) assessed using GPS tracking during exercise
Time Frame
Change from baseline to 32 weeks
Title
Exercise intensity - Internal load
Description
Assessed by the heart rate
Time Frame
Change from baseline to 32 weeks
Title
Exercise intensity - Rating of perceived exertion
Description
Assessed using a 6-20 borg scale (minimum effort = 6; maximum effort = 10).
Time Frame
Change from baseline to 32 weeks
Title
Cogntive function
Description
Assessed by the Montreal Cognitive Assessment
Time Frame
Change from baseline to 32 weeks
Title
Blood pressure
Description
Assessed using a digital sphygmomanometer
Time Frame
Change from baseline to 32 weeks
Title
Resting heart rate
Description
Assessed using a digital sphygmomanometer
Time Frame
Change from baseline to 32 weeks
Title
LDL-cholesterol
Description
Blood sample will be taken for analysis of levels of LDL-cholesterol
Time Frame
Change from baseline to 32 weeks
Title
HDL-cholesterol
Description
Blood sample will be taken for analysis of levels of HDL-cholesterol
Time Frame
Change from baseline to 32 weeks
Title
Total cholesterol
Description
Blood sample will be taken for analysis of levels of total cholesterol
Time Frame
Change from baseline to 32 weeks
Title
Triglycerides
Description
Blood sample will be taken for analysis of levels of triglycerides
Time Frame
Change from baseline to 32 weeks
Title
Prostate specific antigen (PSA)
Description
Blood sample will be taken for analysis of levels of PSA
Time Frame
Change from baseline to 32 weeks
Title
Creatinine
Description
Blood sample will be taken for analysis of levels of creatinine
Time Frame
Change from baseline to 32 weeks
Title
High sensitivity C-reactive protein (HS-CRP)
Description
Blood sample will be taken for analysis of levels of HS-CRP
Time Frame
Change from baseline to 32 weeks
Title
N-terminal type B natriuretic peptide (NT-proBNP)
Description
Blood sample will be taken for analysis of levels of NT-proBNP
Time Frame
Change from baseline to 32 weeks
Title
Vitamin D
Description
Blood sample will be taken for analysis of levels of vitamin D
Time Frame
Change from baseline to 32 weeks
Title
Osteocalcin
Description
Blood sample will be taken for analysis of levels of
Time Frame
Change from baseline to 32 weeks
Title
C-Telopeptide of Collagen Cross-links (CTx)
Description
Blood sample will be taken for analysis of levels of CTx
Time Frame
Change from baseline to 32 weeks
Title
Bone Specific Alkaline Phosphatase (BSAP)
Description
Blood sample will be taken for analysis of levels of BSAP
Time Frame
Change from baseline to 32 weeks
Title
Tartrate-Resistant Acid Phosphatase (TRAP)
Description
Blood sample will be taken for analysis of levels of TRAP
Time Frame
Change from baseline to 32 weeks
Title
Glycated hemoglobin
Description
Blood sample will be taken for analysis of levels of glycated hemoglobin
Time Frame
Change from baseline to 32 weeks
Title
Testosterone
Description
Blood sample will be taken for analysis of levels of testosterone
Time Frame
Change from baseline to 32 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia Capela, MD
Organizational Affiliation
Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Vila Nova de Gaia / Espinho
City
Vila Nova de Gaia
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Walking Football as a Supportive Medicine for Patients With Prostate Cancer
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