Effects of Continuous and Interval Physical Training Through the Intensity of the Incremental Shuttle Walk Test, on Functional Capacity and Quality of Life in Women With Malignant Breast Cancer During Chemotherapy Treatment

NCT ID: NCT05241925

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2025-12-30

Brief Summary

Cancer on the world stage remains a major public health problem and the most common type among women.

Female breast cancer survivors often have multiple comorbidities such as diabetic, heart disease, sarcopenia, arthritis, hypertension, and others. In addition to fatigue, reduced functional capacity of the affected upper limb and decreased quality of life. The effects of antineoplastic treatment associated with chronic diseases predispose the emergence of cardiotoxicity, increasing the risk of developing cardiovascular diseases (CVD) and may lead to a decline in quality of life. This situation is due to the adverse effects that antineoplastic therapy exerts on the cardiovascular system.

According to the American Heart Association and American Cancer Society, physical exercise is one of the strategies adopted to prevent and reduce the effects of anticancer therapy, promoting effects on cardiovascular reserve5,6. Currently, although physical activity is essential for cancer survivors, the most effective exercise strategies (intensity, duration and type of exercise) to improve complications from breast cancer have not yet been defined.

The aim of the study is to investigate the effects of different types of physical training associated with functional capacity and quality of life in women undergoing antineoplastic treatment for breast cancer.

Detailed Description

Cancer is a universal term used for a large group of diseases, characterized by the disordered growth of cells beyond their usual limits, which can affect adjacent parts of the body and/or spread to other organs and tissues. Breast cancer worldwide is a major public health problem, being among all types of neoplasm the most common among women, regardless of age and ethnicity.

Treatment for breast cancer may include surgery, radiation therapy, and systemic therapies such as chemotherapy, hormone therapy, or biological therapy. A number of factors are considered to determine the treatment and sequence of therapies. With advances in early detection and treatment of cancer, the survival rate has increased in more developed countries, reaching 85% in the first five years after diagnosis.

The survival of patients with breast cancer has increased, generating greater concern for the individual's overall well-being. Chemotherapy treatments can cause short or long-term cardiorespiratory limitations, reduced functional capacity and worse quality of life, making daily activities difficult for these patients.

Conditions

Breast Cancer Female; Exercise Addiction

Study Design

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

Study Groups

Combined Training + Resistance Training

Combined training (continuous aerobic + resistance) The protocol will consist of supervised exercise lasting 1h10min each session (5 min of warm-up, 30 min of aerobic exercise, 30 min of resistance exercise and 5 min of cool-down/relaxation).

And Resistance Training

• Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Group Type: EXPERIMENTAL

Rehabilitation, exercise

Intervention Type: OTHER

Combined training (continuous aerobic + resistance) The protocol will consist of supervised exercise lasting 1h10min each session (5 min of warm-up, 30 min of aerobic exercise, 30 min of resistance exercise and 5 min of cool-down/relaxation).

Combined training (high-intensity interval (IAI) + resistance) - Supervised exercise lasting 30 min each session (5 min warm-up, 20 min IAI and 5 min cool-down/relaxation).

And Resistance Training

• Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Hitt Training + Resistance Training

Combined training (high-intensity interval (IAI) + resistance) - Supervised exercise lasting 30 min each session (5 min warm-up, 20 min IAI and 5 min cool-down/relaxation).

And Resistance Training

• Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Group Type: EXPERIMENTAL

Rehabilitation, exercise

Intervention Type: OTHER

Combined training (continuous aerobic + resistance) The protocol will consist of supervised exercise lasting 1h10min each session (5 min of warm-up, 30 min of aerobic exercise, 30 min of resistance exercise and 5 min of cool-down/relaxation).

Combined training (high-intensity interval (IAI) + resistance) - Supervised exercise lasting 30 min each session (5 min warm-up, 20 min IAI and 5 min cool-down/relaxation).

And Resistance Training

• Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Interventions

Rehabilitation, exercise

Combined training (continuous aerobic + resistance) The protocol will consist of supervised exercise lasting 1h10min each session (5 min of warm-up, 30 min of aerobic exercise, 30 min of resistance exercise and 5 min of cool-down/relaxation).

Combined training (high-intensity interval (IAI) + resistance) - Supervised exercise lasting 30 min each session (5 min warm-up, 20 min IAI and 5 min cool-down/relaxation).

And Resistance Training

• Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Diagnosis of confirmed breast cancer. Duration of adjuvant chemotherapy treatment. Undergoing surgery for breast cancer treatment.

Exclusion Criteria

• neoplasm prior to breast cancer
• heart disease;
• musculoskeletal disorder;
• respiratory disease;
• uncontrolled arterial hypertension - factors that limit the performance of any of the assessments and/or training in the study.
• Not having undergone chemotherapy or radiotherapy prior to the diagnosis of breast cancer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

LUCIANA MARIA MALOSA SAMPAIO

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Sampaio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Central Contacts

Luciana Sampaio, PhD

Role: CONTACT

lucianamalosa@gmail.com

+5511 996002075

Grasiani Breggue Pires, Ms

Role: CONTACT

gbreggue@gmail.com

+5511931467373

Other Identifiers

Breast Cancer

Identifier Type: -

Identifier Source: org_study_id