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Football Fitness After Breast Cancer (FFABC)

30. september 2021 oppdatert av: Jacob Uth, University of Copenhagen

A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer

Late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. However only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for breast cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

69

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • University Hospital of Copenhagen, Rigshospitalet

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Women surgically managed for breast cancer, local and regional advanced breast cancer.
  • Completion of adjuvant chemotherapy and radiation therapy.
  • Legally competent persons with ability to read and understand Danish.
  • Signed informed consent.
  • Performance level 0-1 (WHO).

Exclusion Criteria:

  • WHO performance level > 1.
  • Osteoporosis (T-score < -2.5).
  • Known metastatic breast cancer (stage IV).
  • Women in DBCG-group I (age => 60 years, tumor =< 10 mm, invasive ductal carcinoma grade I, invasive lobular carcinoma grade I / II, estrogen receptor positive and HER2 normal).
  • Cardiovascular or pulmonary disorders (e.g., arrhythmias, ischemic heart disease, unregulated high blood pressure, chronic obstructive lung disease).
  • Ongoing anticoagulant therapy (vitamin K antagonists; Marevan, Marcoumar and low molecular weight heparins; Innohep, Clexane, Fragmin) for pulmonary embolism or deep venous thrombosis (DVT) due to increased bleeding risk of falls and clashes with other players during exercise.
  • Current or scheduled chemotherapy and radiation therapy in the intervention period (12 months).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Football fitness

Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury.
Atferdsmessig: Football fitness

The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors
Ingen inngripen: Control group
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Tidsramme: 6 months and 12 months.
Incremental test to exhaustion on a cycle ergometer.
6 months and 12 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Tidsramme: 6 months and 12 months.
Assessed by dual energy x-ray absorptiometry.
6 months and 12 months.
Mean change in whole-body weight from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Body weight was measured with a digital platform scale.
6 month and 12 month.
Mean change in whole-body muscle mass from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by dual energy x-ray absorptiometry.
6 month and 12 month.
Mean change in muscle strength from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Dynamic concentric muscle strength for the knee extensors (1RM).
6 month and 12 month.
Mean change in balance from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Single-leg flamingo balance test.
6 month and 12 month.
Mean change in blood pressure from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Blood pressure will be measured with a digital sphygmomanometer.
6 month and 12 month.
Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.
6 month and 12 month.
Mean change in cholesterol from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).
6 month and 12 month.
Self-reported physical activity from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by the International Physical Activity Questionnaire (IPAQ).
6 month and 12 month.
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by the supplement EORTC QLQ-BR23.
6 month and 12 month.
Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
6 month and 12 month.
Self-reported functional level in upper extremities from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by disabilities of the arm, shoulder and hand (DASH).
6 month and 12 month.
Self-reported health related quality of life from baseline to month 6 and month 12.
Tidsramme: 6 month and 12 month.
Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
6 month and 12 month.
Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
Tidsramme: 6 month and 12 month.
Assessed by dual energy x-ray absorptiometry.
6 month and 12 month.
Mean change in total body and leg bone mineral content (BMC).
Tidsramme: 6 month and 12 month.
Assessed by dual energy x-ray absorptiometry.
6 month and 12 month.

Samarbeidspartnere og etterforskere

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Sponsor

University of Copenhagen

Samarbeidspartnere

University of Southern Denmark

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mars 2017

Primær fullføring (Faktiske)

30. november 2019

Studiet fullført (Faktiske)

20. januar 2020

Datoer for studieregistrering

Først innsendt

13. september 2017

Først innsendt som oppfylte QC-kriteriene

13. september 2017

Først lagt ut (Faktiske)

15. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

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  • FFABC

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