Adaptations to Breast Cancer and Exercise (ABRACE)

May 2, 2022 updated by: João Henkin

Effects of Different Volumes of Combined Training on Neuromuscular Parameters of Women in Initial Treatment for Breast Cancer: A Randomized Controlled Trial

This study aims to investigate the effects of different volumes of combined training on fatigue, neuromuscular variables, morphological, cardiorespiratory capacity, functionality, and quality of life, in breast cancer (BCa) women undergoing primary treatment. Two thirds will be the intervention group that will perform combined training, while the other third will be the control group that will have physiotherapy sessions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

Although chemotherapy and radiation are mainstream treatment modalities, patients will often experience treatment-related side effects such as impairments to the neuromuscular and cardiovascular systems and reduction in quality of life (QoL).To date, numerous positive effects on neuromuscular and aerobic parameters in response to resistance and aerobic training have been reported when both training modalities were simultaneously performed (i.e. combined training - COMB) in BCa patients. However, there is a lack of data regarding the prescription of this modality in BCa patients, as the necessary dose of resistance training for significant improve in fatigue, neuromuscular, and quality of life. In this sense, no previous studies investigate the effect of different volumes of resistance training in BCa patients, providing important informations about the prescription in this clinical population.

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.
84

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 Locations

  • Brazil
      • Pôrto Alegre, Brazil
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
          • Alessandra Morelle, Dr.
      • Pôrto Alegre, Brazil
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
          • Ronei Pinto, phd

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast cancer diagnostic at I and II stages;
  • Adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed);
  • More than 18 years.

Exclusion Criteria:

  • Current smoking
  • Diabetic neuropathy;
  • Hypertension uncontrolled;
  • Heart failure;
  • Clinical depression;
  • Skeletal muscle impairment which not allow physical exercise.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Control group
Patients who are randomized in control group will receive the usual care in their respective hospital.
Other: Control group
The usual care will be recommended to avoid systematic physical exercise for 3 months and will receive general clinical recommendations such as nutritional intake and lifestyle issues in their respective hospital.
Experimental: Single-set group
Patients who are randomized in Single-set (SS) group, will receive 12-week of combined training, twice a week, composed by 10 resistance exercises and 20-25 minutes aerobic exercise at 80-95% of the second ventilatory threshold heart rate in a cycle. One-single set will be performed per exercise at 60-80%1-RM, with 1-1,5min of rest between the exercises.
Other: Combined training
Resistance exercises performed with different volumes (i.e. one-single set and multiple-sets) and 20-25 minutes of aerobic exercise will be performed twice a week, during 12 weeks.
Other Names:
  • Concurrent training
Experimental: Multiple-sets group
Patients who are randomized in Multiples-set (MS) group, will receive 12-week of combined training, twice a week, composed by 10 resistance exercises and 20-25 minutes aerobic exercise at 80-95% of the second ventilatory threshold heart rate in a cycle. Regarding resistance exercises, three set will be performed per exercise at 60-80%1-RM, with 1-1,5min of rest between sets and the exercises.
Other: Combined training
Resistance exercises performed with different volumes (i.e. one-single set and multiple-sets) and 20-25 minutes of aerobic exercise will be performed twice a week, during 12 weeks.
Other Names:
  • Concurrent training

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
Neuromuscular fatigue
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Fatigue will be assessed by Fatigue index in isokinetic device.
Changes from baseline are assessed after the intervention (week 13)
Subjective fatigue
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Fatigue will be assessed by Piper fatigue scale (PFS). The PFS in its current form is composed of 22 numerically scaled, "0" to "10" items (i.e. 0, none fatigue; 10, severe fatigue) that measure four dimensions of subjective fatigue: behavioral/severity (6 items; # 2-7); affective meaning (5 items: # 8-12); sensory (5 items: # 13-17); and cognitive/mood (6 items: # 18-23). These 22 items are used to calculate the four sub-scale/dimensional scores and the total fatigue scores.
Changes from baseline are assessed after the intervention (week 13)

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
Body composition
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Body composition will be assessed by Dual-energy X-ray absorptiometry
Changes from baseline are assessed after the intervention (week 13)
Muscle thickness
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Muscle thickness will be assessed by ultrasound images of quadriceps femoris and biceps.
Changes from baseline are assessed after the intervention (week 13)
Echo intensity
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Echo intensity is a grey scale for analyze the image that ranging from 0 (black) to 255 (white), and will be assessed by ultrasound images of quadriceps femoris and biceps.
Changes from baseline are assessed after the intervention (week 13)
VO2máx
Time Frame: Changes from baseline are assessed after the intervention (week 13)
VO2máx will be assessed by an incremental protocol in a cycle ergometer
Changes from baseline are assessed after the intervention (week 13)
Knee extension muscle strength
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Knee extension muscle strength will be assessed by a bilateral 1-repetition maximum, reported in Kg.
Changes from baseline are assessed after the intervention (week 13)
Unilateral vertical bench press muscle strength
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Unilateral vertical bench press muscle strength will be assessed by an unilateral 1-repetition maximum on both sides, reported in Kg.
Changes from baseline are assessed after the intervention (week 13)
Knee extension peak torque
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Knee extension peak torque will be assessed by maximal voluntary isometric contraction on the right side, in a isokinetic dynamometer.
Changes from baseline are assessed after the intervention (week 13)
Quality of life assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23
Time Frame: Changes from baseline are assessed after the intervention (week 13)
Quality of life will be assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23. The EORTIC is composed by 53 questions scaled "0" to "4", and "0" to "7". These 53 items are used to compute four domains (i.e. global, functions, symptoms, and BR23 functions).
Changes from baseline are assessed after the intervention (week 13)
Functional Performance: Timed-up and go test
Time Frame: Changes from baseline are assessed after the intervention (week 13)
The timed-up-and-go requires an individual to stand up from a seated position in a chair, walk 2.44m, turn around a cone, walk back to the chair and sit down.
Changes from baseline are assessed after the intervention (week 13)
Functional performance: 5-repetitions Sit-to-stand test
Time Frame: Changes from baseline are assessed after the intervention (week 13)
For the 5-repetition sit-to-stand test, participants are instructed to start the test in a seated position with arms folded across the chest. After the start command, participants stand up until full knees extension and then back to a seated position. The time is stopped when the participants touch the seat after five complete repetitions.
Changes from baseline are assessed after the intervention (week 13)
Functional performance: 30-seconds arm-curl
Time Frame: Changes from baseline are assessed after the intervention (week 13)
The arm-curl test determines the maximal number of times a 2kg dumbbell can be lifted with the dominant arm through elbow flexion in 30 seconds. Participants start the test seated in a chair, with arms extended and forearm maintained in supinated position during full range of motion.
Changes from baseline are assessed after the intervention (week 13)
Functional Performance: Stair Climbing
Time Frame: Changes from baseline are assessed after the intervention (week 13)
For the stair-climbing test, participants are instructed to climb a 10-step staircase without skip steps or using the handrail (except in need of balance to prevent falls
Changes from baseline are assessed after the intervention (week 13)

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.
João Henkin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Moinhos de Vento

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: Ronei Pinto, PhD, Federal University of Rio Grande do Sul

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 (Actual)

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.
October 7, 2017

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 31, 2024

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.
August 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).
October 10, 2017

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.
October 13, 2017

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.
October 19, 2017

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 6, 2022

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 2, 2022

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.
May 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.
  • 72983017.3.0000.5347

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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