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

NCT ID: NCT02804308

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-06-30

Brief Summary

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.

Conditions

Breast Cancer; Aromatase Inhibitors; Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Control with breast cancer and without breast cancer

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Combined Training with breast cancer and without breast cancer

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.

Group Type: EXPERIMENTAL

Combined Training

Intervention Type: BEHAVIORAL

Interventions

Combined Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Thais Reis Silva de Paulo

masters degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismael F Freitas Junior, Doctor

Role: STUDY_DIRECTOR

UPECLIN HC FM Botucatu Unesp

References

Felipe J, Viezel J, Reis AD, da Costa Barros EA, de Paulo TRS, Neves LM, Junior IFF. Relationship of different intensities of physical activity and quality of life in postmenopausal women. Health Qual Life Outcomes. 2020 May 6;18(1):123. doi: 10.1186/s12955-020-01377-1.

Reference Type: DERIVED

PMID: 32375779 (View on PubMed)

Other Identifiers

CAAE46727715100005402

Identifier Type: -

Identifier Source: org_study_id