Effects of Different Volumes of Combined Training on Neuromuscular Parameters of Women in Initial Treatment for Breast Cancer: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Neuromuscular fatigue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Knee extension muscle strength(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(Changes from baseline are assessed after the intervention (week 13))
- Muscle thickness(Changes from baseline are assessed after the intervention (week 13))
- Knee extension peak torque(Changes from baseline are assessed after the intervention (week 13))
- Functional performance: 5-repetitions Sit-to-stand test(Changes from baseline are assessed after the intervention (week 13))
- Body composition(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))
- Unilateral vertical bench press muscle strength(Changes from baseline are assessed after the intervention (week 13))
- Functional Performance: Stair Climbing(Changes from baseline are assessed after the intervention (week 13))
- Functional Performance: Timed-up and go test(Changes from baseline are assessed after the intervention (week 13))
- Functional performance: 30-seconds arm-curl(Changes from baseline are assessed after the intervention (week 13))
Investigators
João Henkin
Principal investigator
Federal University of Rio Grande do Sul