Adaptations to Breast Cancer and Exercise (ABRACE)

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Control group; Other: Combined training

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: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joao Henkin, BsC; Phone Number: +5551 99302 3340; Email: joaohenkin@gmail.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body composition will be assessed by Dual-energy X-ray absorptiometry	Changes from baseline are assessed after the intervention (week 13)
Muscle thickness	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: João Henkin
• Collaborators: Hospital Moinhos de Vento
• Investigators: Principal Investigator: Ronei Pinto, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2017
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): August 30, 2025

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Fatigue; Combined training
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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