Adaptations to Breast Cancer and Exercise

NCT03314168 | Unknown

• 1 other identifier: 72983017.3.0000.5347
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Combined training; Fatigue

Outcome Measures

Primary Outcomes (2)

• Neuromuscular fatigue

  Fatigue will be assessed by Fatigue index in isokinetic device.

  Changes from baseline are assessed after the intervention (week 13)

• Subjective fatigue

  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 Outcomes (12)

• Body composition

  Changes from baseline are assessed after the intervention (week 13)

• Muscle thickness

  Changes from baseline are assessed after the intervention (week 13)

• Echo intensity

  Changes from baseline are assessed after the intervention (week 13)

• VO2máx

  Changes from baseline are assessed after the intervention (week 13)

• Knee extension muscle strength

  Changes from baseline are assessed after the intervention (week 13)

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Control group

Single-set group

EXPERIMENTAL

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

Multiple-sets group

EXPERIMENTAL

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

Interventions

Combined training 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.

Also known as: Concurrent training

Multiple-sets group; Single-set group

Control group 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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• João Henkin: lead
• Hospital Moinhos de Vento: collaborator

Study Sites (2)

Hospital Moinhos de Vento

Pôrto Alegre, Brazil

RECRUITING

Universidade Federal do Rio Grande do Sul

Pôrto Alegre, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 36589863 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ronei Pinto, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Henkin, BsC

CONTACT

+5551 99302 3340; joaohenkin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 19, 2017
• Study Start: October 7, 2017
• Primary Completion: December 31, 2024
• Study Completion: August 30, 2025
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

BR (2)