- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00359060
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.
In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.
This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.
Studientyp
Einschreibung
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
-
Utrecht, Niederlande, 3508 GA
- University Medical Center Utrecht, Julius Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Women aged 50 -69 year
- > 12 months since last menses
- Non-smokers (at least 12 months)
- Sedentary
- Knowledge of the Dutch language
- Agreement to be randomly assigned to either the exercise intervention or control group
- Informed consent to participate in all screening and study activities
Exclusion Criteria:
- Use of hormone replacement or oral contraceptives in past 6 months
- Morbidly obese (BMI > 40)
- BMI < 22
- Currently on or planning to go on a strict diet
- Ever diagnosed with breast cancer
- Diagnosis of other types of cancer in the past 5 years
- Diabetes mellitus or other endocrine related diseases
- Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
- Alcohol or drug abuse
- Maintenance use of corticosteroids
- Use of beta blockers
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
Insulinsensitivität
|
|
Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
|
|
Serum concentrations of endogenous androgens: testosterone, androstenedione
|
|
Serum concentrations of sex hormone binding globulin
|
|
Serum concentrations of fasting insulin
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
Blutdruck
|
|
Gewicht
|
|
Body-Mass-Index (BMI)
|
|
Medikamenteneinnahme
|
|
Körperliche Fitness
|
|
Amount of total body fat and intra-abdominal fat
|
|
Body fat distribution
|
|
Waist to hip ratio
|
|
Lifestyle parameters (covariates)
|
|
Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
|
|
Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
|
|
Alcohol consumption
|
|
Reproductive factors
|
|
Medical history
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jantine Schuit, PhD, Dutch Institute of Public Health and the Environment
- Hauptermittler: Petra HM Peeters, PhD, University Medical Center Utrecht, Julius Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UU 2003-2793
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .