Adaptations to Breast Cancer and Exercise

NCT ID: NCT03314168

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-07

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

Patients who are randomized in control group will receive the usual care in their respective hospital.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Combined training

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Combined training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Concurrent training

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Moinhos de Vento

OTHER

Sponsor Role collaborator

João Henkin

OTHER

Sponsor Role lead

Responsible Party

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João Henkin

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ronei Pinto, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Hospital Moinhos de Vento

Pôrto Alegre, , Brazil

Site Status RECRUITING

Universidade Federal do Rio Grande do Sul

Pôrto Alegre, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Joao Henkin, BsC

Role: CONTACT

+5551 99302 3340

Facility Contacts

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Alessandra Morelle, Dr.

Role: primary

Ronei Pinto, phd

Role: primary

References

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Henkin JS, Rosa DD, Morelle AM, Caleffi M, Pinto SS, Pinto RS. Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. Contemp Clin Trials Commun. 2022 Dec 20;31:101053. doi: 10.1016/j.conctc.2022.101053. eCollection 2023 Feb.

Reference Type DERIVED
PMID: 36589863 (View on PubMed)

Other Identifiers

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72983017.3.0000.5347

Identifier Type: -

Identifier Source: org_study_id

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