Clinical trial NCT03314168: Adaptations to Breast Cancer and Exercise
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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Combined training
Fatigue
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
First posted: 2017-10-19
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Neuromuscular fatigue
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Subjective fatigue
timeFrame: Changes from baseline are assessed after the intervention (week 13)
Secondary outcomes:
measure: Body composition
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Muscle thickness
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Echo intensity
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: VO2máx
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Knee extension muscle strength
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Unilateral vertical bench press muscle strength
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Knee extension peak torque
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Quality of life assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Functional Performance: Timed-up and go test
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Functional performance: 5-repetitions Sit-to-stand test
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Functional performance: 30-seconds arm-curl
timeFrame: Changes from baseline are assessed after the intervention (week 13)
measure: Functional Performance: Stair Climbing
timeFrame: Changes from baseline are assessed after the intervention (week 13)
Other outcomes:
Locations:
city: Pôrto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Pôrto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Ronei Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References: