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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

Primary Purpose

Breast Cancer Female, Exercise Addiction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation, exercise
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring Breast Cancer, Exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Combined Training + Resistance Training

    Hitt Training + Resistance Training

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Distance Incremental Shuttle Walk Test (SWTI)
    Distance walking meters
    Maximum endurance test (1RM)
    Kg

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 26, 2022
    Last Updated
    May 8, 2023
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05241925
    Brief Title
    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
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 20, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2025 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Female, Exercise Addiction
    Keywords
    Breast Cancer, Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined Training + Resistance Training
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Hitt Training + Resistance Training
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Rehabilitation, exercise
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Distance Incremental Shuttle Walk Test (SWTI)
    Description
    Distance walking meters
    Time Frame
    Distance Incremental Shuttle Walk Test (SWTI)
    Title
    Maximum endurance test (1RM)
    Description
    Kg
    Time Frame
    Maximum endurance test (1RM)
    Secondary Outcome Measure Information:
    Title
    Time Grocery Shelving Task Test
    Description
    Seconds
    Time Frame
    Time Grocery Shelving Task Test
    Title
    European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
    Description
    Score
    Time Frame
    European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
    Title
    Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
    Description
    Score
    Time Frame
    Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
    Title
    Brief Fatigue Inventory Questionnaire (BFI)
    Description
    Score
    Time Frame
    Brief Fatigue Inventory Questionnaire (BFI)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luciana Sampaio, PhD
    Phone
    +5511 996002075
    Email
    lucianamalosa@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Grasiani Breggue Pires, Ms
    Phone
    +5511931467373
    Email
    gbreggue@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luciana Sampaio, PhD
    Organizational Affiliation
    University of Nove de Julho
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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