Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Completed

Conditions: Breast Cancer; Aromatase Inhibitors; Postmenopausal

Treatments: Behavioral: Combined Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02804308

CAAE46727715100005402

Details and patient eligibility

About

Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.

Enrollment: 83 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal, defined by the absence of periods for the past 12 months;
• Breast cancer diagnosis stages 1 to 3;
• The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
• No abnormalities on screening physical or any health problems that contraindicate study participation;
• No contraindications for treadmill testing or entry into a training program, including any of the following:
• Myocardial infarction within the past 6 months
• Pulmonary edema
• Myocarditis Pericarditis
• Unstable angina
• Pulmonary embolism or deep vein thrombosis
• Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
• Uncontrolled arrhythmia
• No significant mental illness
• Have medical certificate to perform exercise testing and participate in combined training
• Able to answer Questionnaires
• No concurrent participation in any other organized exercise program;
• Live in Presidente Prudente
• Sign the consent form and formal clarification for participation in the study.

Exclusion criteria

• Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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83 participants in 2 patient groups

Group Control with breast cancer and without breast cancer

No Intervention group

Description:

Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months

Combined Training with breast cancer and without breast cancer

Experimental group

Description:

Combined Training: 36 weeks duration, 3 times a week on nonconsecutive days. The combined training program lasts 70 minutes per session, with 40 minutes of resistance training and 30 minutes of aerobic training.

Treatment:

Behavioral: Combined Training