Breast CancerABRACENCT03314168
Adaptations to Breast Cancer and Exercise
A study testing Combined training in people with Breast Cancer, run by João Henkin at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Combined training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesBrazil
- Study dates
- 7 Oct 2017to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnostic at I and II stages;
- Adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed);
- More than 18 years.
Who cannot join
- Current smoking
- Diabetic neuropathy;
- Hypertension uncontrolled;
- Heart failure;
- Clinical depression;
- Skeletal muscle impairment which not allow physical exercise.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Moinhos de Vento
Pôrto Alegre
Alessandra Morelle, Dr.
- Recruiting
Universidade Federal do Rio Grande do Sul
Pôrto Alegre
Ronei Pinto, phd
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Combined training, Control group
- Keywords
- Breast Cancer, Combined training, Fatigue
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trainingOther
Also called Concurrent 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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients who are randomized in control group will receive the usual care in their respective hospital. Receives: 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. Receives: 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. Receives: Other: Combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular fatigue
Fatigue will be assessed by Fatigue index in isokinetic device.
Measured: 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.
Measured: Changes from baseline are assessed after the intervention (week 13)
Secondary outcomes (12)
Body composition
Body composition will be assessed by Dual-energy X-ray absorptiometry
Measured: 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.
Measured: 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.
Measured: Changes from baseline are assessed after the intervention (week 13)
VO2máx
VO2máx will be assessed by an incremental protocol in a cycle ergometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Changes from baseline are assessed after the intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start7 Oct 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- João Henkin
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Moinhos de Vento
- Responsible party
- Sponsor-investigator, João Henkin, Federal University of Rio Grande do Sul
- Investigators
- Ronei Pinto, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314168
- Sponsor's protocol ID
- 72983017.3.0000.5347
- Acronym
- ABRACE
- Status last verified
- May 2022
- First submitted
- 10 Oct 2017
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36589863
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Volumes of Combined Training on Neuromuscular Parameters of Women in Initial Treatment for Breast Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03314168
- Acronym / sponsor ID
- ABRACE / 72983017.3.0000.5347
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Combined training, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- João HenkinUniversity, hospital or other
- Collaborators
- Hospital Moinhos de Vento
- Study start
- 7 Oct 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupPatients who are randomized in control group will receive the usual care in their respective hospital. |
| Single-set group | Experimental | Other: Combined trainingPatients 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. |
| Multiple-sets group | Experimental | Other: Combined trainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer diagnostic at I and II stages;
- Adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed);
- More than 18 years.
Key exclusion criteria (6 listed)
- Current smoking
- Diabetic neuropathy;
- Hypertension uncontrolled;
- Heart failure;
- Clinical depression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined trainingAlso: Concurrent trainingResistance 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 | Multiple-sets group, Single-set group |
| Control groupThe 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. | Other | Control group |
Primary outcome
Neuromuscular fatigue
Time frame: Changes from baseline are assessed after the intervention (week 13)
Fatigue will be assessed by Fatigue index in isokinetic device.
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.
12 secondary outcomes
Body composition
Time frame: Changes from baseline are assessed after the intervention (week 13)
Muscle thickness
Time frame: Changes from baseline are assessed after the intervention (week 13)
Echo intensity
Time frame: Changes from baseline are assessed after the intervention (week 13)
VO2máx
Time frame: 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)
Unilateral vertical bench press muscle strength
Time frame: 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)
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)
Functional Performance: Timed-up and go test
Time frame: 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)
Functional performance: 30-seconds arm-curl
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 36589863Henkin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronei Pinto, PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined training in people with Breast Cancer, run by João Henkin at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao Henkin, BsC (+5551 99302 3340, joaohenkin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular fatigue (time frame: Changes from baseline are assessed after the intervention (week 13)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.