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Table 2 Study population: inclusion and exclusion criteria

From: Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study)

Inclusion criteria (all criteria must apply):

• Women with a pathogenic BRCA1 or BRCA2 germline mutation

• Age between 18 and 69 years

• Written informed consent

 

Exclusion criteria:

• Metastatic tumor disease

• Expectancy of life <3 years

• Limited cardiovascular and lung diseases (instable CHC, heart failure stage IV, COPD GOLD IV, maximal blood pressure at rest >160/100 mmHg)

• Significant orthopedic problems, not allowing exercise

• Serious diseases, not allowing a participation in group interventions (e.g., psychiatric or internal ailment)

• Karnofsky status scale <60%

• Women with VO2 max > 150% of general population

• Women with an exercise capacity <50 W

• Food allergies not allowing consumption of a Mediterranean dietary pattern

• Vegans

• BMI < 15 kg/m2

• Pregnancy

• Insufficient knowledge of the German language

• Current participation in other lifestyle intervention trials

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