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Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy

16. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

57

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Sædvanlig pleje
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.
Adfærdsmæssigt: Soccer training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bone Mineral Density
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Cardiorespiratory fitness (Vo2 peak)
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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).
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Patient reported outcomes
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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)
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Heart function
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Glucose tolerance
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Oral Glucose Tolerance Test
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Postural Balance
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Physical function
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Hip to waist ratio
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Hip and waist circumference will be measured and the hip to waist ratio will be calculated
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Muscle Strength
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Blood markers
Tidsramme: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Markers of inflammation and bone metabolism will be obtained after overnight fasting
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Copenhagen

Samarbejdspartnere

Novo Nordisk A/S
Danish Cancer Society
TrygFonden, Denmark
Beckett Foundation

Efterforskere

  • Ledende efterforsker: Mikael Rørth, Professor, University of Copenhagen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

17. oktober 2012

Først indsendt, der opfyldte QC-kriterier

18. oktober 2012

Først opslået (Skøn)

22. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIRE-04

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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