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

May 8, 2023 updated by: LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distance Incremental Shuttle Walk Test (SWTI)
Time Frame: Distance Incremental Shuttle Walk Test (SWTI)
Distance walking meters
Distance Incremental Shuttle Walk Test (SWTI)
Maximum endurance test (1RM)
Time Frame: Maximum endurance test (1RM)
Kg
Maximum endurance test (1RM)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time Grocery Shelving Task Test
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)
Time Frame: 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)
Time Frame: Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
Score
Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
Brief Fatigue Inventory Questionnaire (BFI)
Time Frame: Brief Fatigue Inventory Questionnaire (BFI)
Score
Brief Fatigue Inventory Questionnaire (BFI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciana Sampaio, PhD, University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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