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

NCT05241925 | Unknown DMC

• 1 other identifier: Breast Cancer
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female; Exercise Addiction

Keywords

Breast Cancer; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time Grocery Shelving Task Test

  Time Grocery Shelving Task Test

• European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

  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)

  Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)

• Brief Fatigue Inventory Questionnaire (BFI)

  Brief Fatigue Inventory Questionnaire (BFI)

Study Arms (2)

Combined Training + Resistance Training

EXPERIMENTAL

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

Hitt Training + Resistance Training

EXPERIMENTAL

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

Interventions

Rehabilitation, exercise 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

Combined Training + Resistance Training; Hitt Training + Resistance Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Luciana Sampaio, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Sampaio, PhD

CONTACT

+5511 996002075; lucianamalosa@gmail.com

Grasiani Breggue Pires, Ms

CONTACT

+5511931467373; gbreggue@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: May 20, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 9, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share