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Adaptations to Breast Cancer and Exercise (ABRACE)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined training
Control group
Sponsored by
João Henkin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Combined training, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Moinhos de VentoRecruiting
  • Universidade Federal do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Single-set group

Multiple-sets group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Neuromuscular fatigue
Fatigue will be assessed by Fatigue index in isokinetic device.
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.

Secondary Outcome Measures

Body composition
Body composition will be assessed by Dual-energy X-ray absorptiometry
Muscle thickness
Muscle thickness will be assessed by ultrasound images of quadriceps femoris and biceps.
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.
VO2máx
VO2máx will be assessed by an incremental protocol in a cycle ergometer
Knee extension muscle strength
Knee extension muscle strength will be assessed by a bilateral 1-repetition maximum, reported in Kg.
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.
Knee extension peak torque
Knee extension peak torque will be assessed by maximal voluntary isometric contraction on the right side, in a isokinetic dynamometer.
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).
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.
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.
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.
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

Full Information

First Posted
October 10, 2017
Last Updated
May 2, 2022
Sponsor
João Henkin
Collaborators
Hospital Moinhos de Vento
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1. Study Identification

Unique Protocol Identification Number
NCT03314168
Brief Title
Adaptations to Breast Cancer and Exercise
Acronym
ABRACE
Official Title
Effects of Different Volumes of Combined Training on Neuromuscular Parameters of Women in Initial Treatment for Breast Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
João Henkin
Collaborators
Hospital Moinhos de Vento

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Combined training, Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients who are randomized in control group will receive the usual care in their respective hospital.
Arm Title
Single-set group
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple-sets group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Combined training
Other Intervention Name(s)
Concurrent training
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuromuscular fatigue
Description
Fatigue will be assessed by Fatigue index in isokinetic device.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Subjective fatigue
Description
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.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Secondary Outcome Measure Information:
Title
Body composition
Description
Body composition will be assessed by Dual-energy X-ray absorptiometry
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Muscle thickness
Description
Muscle thickness will be assessed by ultrasound images of quadriceps femoris and biceps.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Echo intensity
Description
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.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
VO2máx
Description
VO2máx will be assessed by an incremental protocol in a cycle ergometer
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Knee extension muscle strength
Description
Knee extension muscle strength will be assessed by a bilateral 1-repetition maximum, reported in Kg.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Unilateral vertical bench press muscle strength
Description
Unilateral vertical bench press muscle strength will be assessed by an unilateral 1-repetition maximum on both sides, reported in Kg.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Knee extension peak torque
Description
Knee extension peak torque will be assessed by maximal voluntary isometric contraction on the right side, in a isokinetic dynamometer.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Quality of life assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23
Description
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).
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Functional Performance: Timed-up and go test
Description
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.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Functional performance: 5-repetitions Sit-to-stand test
Description
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.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Functional performance: 30-seconds arm-curl
Description
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.
Time Frame
Changes from baseline are assessed after the intervention (week 13)
Title
Functional Performance: Stair Climbing
Description
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
Time Frame
Changes from baseline are assessed after the intervention (week 13)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joao Henkin, BsC
Phone
+5551 99302 3340
Email
joaohenkin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronei Pinto, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Moinhos de Vento
City
Pôrto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Morelle, Dr.
Facility Name
Universidade Federal do Rio Grande do Sul
City
Pôrto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronei Pinto, phd

12. IPD Sharing Statement

Learn more about this trial

Adaptations to Breast Cancer and Exercise

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