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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise Addiction; Breast Cancer Female
• Intervention / Treatment: Other: Rehabilitation, exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciana Sampaio, PhD; Phone Number: +5511 996002075; Email: lucianamalosa@gmail.com
• Study Contact Backup: Name: Grasiani Breggue Pires, Ms; Phone Number: +5511931467373; Email: gbreggue@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Incremental Shuttle Walk Test (SWTI)	Distance walking meters	Distance Incremental Shuttle Walk Test (SWTI)
Maximum endurance test (1RM)	Kg	Maximum endurance test (1RM)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Grocery Shelving Task Test	Seconds	Time Grocery Shelving Task Test
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)	Score	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)	Score	Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
Brief Fatigue Inventory Questionnaire (BFI)	Score	Brief Fatigue Inventory Questionnaire (BFI)

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Luciana Sampaio, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2023
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Breast Cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No