Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
16 april 2014 uppdaterad av: Jacob Uth, University of Copenhagen
A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).
The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.
Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.
Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.
It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
57
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Copenhagen, Danmark, 2100
- University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone < 1.7) for at least 6 months at the time of inclusion
Exclusion Criteria:
- WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Kontrollgrupp
Vanlig skötsel
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Aktiv komparator: Soccer Training
12 weeks of soccer training.
(2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks.
Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks).
After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Bone Mineral Density
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Cardiorespiratory fitness (Vo2 peak)
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Patient reported outcomes
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Heart function
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Glucose tolerance
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Oral Glucose Tolerance Test
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Postural Balance
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Assessed standing on a force platform with feet in bilateral, unilateral and tandem position.
Additionally assessed with a modified Flamingo balance test.
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip to waist ratio
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip and waist circumference will be measured and the hip to waist ratio will be calculated
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle Strength
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Blood markers
Tidsram: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Markers of inflammation and bone metabolism will be obtained after overnight fasting
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mikael Rørth, Professor, University of Copenhagen
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Helge EW, Schmidt JF, Brasso K, Helge JW, Jakobsen MD, Andersen LL, Rorth M, Midtgaard J, Krustrup P. Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations. Eur J Appl Physiol. 2016 Mar;116(3):471-80. doi: 10.1007/s00421-015-3301-y. Epub 2015 Nov 30.
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, Brasso K, Jakobsen MD, Sundstrup E, Andersen LL, Rorth M, Midtgaard J, Krustrup P, Helge EW. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016 Apr;27(4):1507-1518. doi: 10.1007/s00198-015-3399-0. Epub 2015 Nov 16.
- Bruun DM, Krustrup P, Hornstrup T, Uth J, Brasso K, Rorth M, Christensen JF, Midtgaard J. "All boys and men can play football": a qualitative investigation of recreational football in prostate cancer patients. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:113-21. doi: 10.1111/sms.12193.
- Uth J, Hornstrup T, Schmidt JF, Christensen JF, Frandsen C, Christensen KB, Helge EW, Brasso K, Rorth M, Midtgaard J, Krustrup P. Football training improves lean body mass in men with prostate cancer undergoing androgen deprivation therapy. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:105-12. doi: 10.1111/sms.12260.
- Krustrup P, Hansen PR, Nielsen CM, Larsen MN, Randers MB, Manniche V, Hansen L, Dvorak J, Bangsbo J. Structural and functional cardiac adaptations to a 10-week school-based football intervention for 9-10-year-old children. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:4-9. doi: 10.1111/sms.12277.
- Uth J, Schmidt JF, Christensen JF, Hornstrup T, Andersen LJ, Hansen PR, Christensen KB, Andersen LL, Helge EW, Brasso K, Rorth M, Krustrup P, Midtgaard J. Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
17 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
18 oktober 2012
Första postat (Uppskatta)
22 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 april 2014
Senast verifierad
1 april 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CIRE-04
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .