Breast cancer survivors Cancer
Conditions
Interventions
Current interventions as of 02/09/2019:
The study is a randomized controlled trial. Patients will be randomly assigned to either an exercise group (combining supervised strength training and home-bas
Sponsors
University of Almería
Patronato Municipal de Deportes. Ayuntamiento de Almería.
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-65 2. Have undergone breast cancer surgery and have finished core treatment (i.e. chemotherapy and/or radiotherapy) in the past 5 years
Exclusion criteria
Exclusion criteria: 1. Metastatic breast cancer. 2. Not awaiting breast reconstruction in the following 6 months. 3. Any pathology that might prevent them from exercising: 3.1 Decompensated heart failure. 3.2 Unstable ischemic heart disease. 3.3 Severe untreated high blood pressure. 3.4 Moderate-severe valvulopathies. 3.5 Aortic aneurysm. 3.6 Moderate-severe COPD 3.7 Pulmonary hypertension. 3.8 Chronic respiratory insufficiency. 4. Patients who perform more than 300 minutes per week of structured exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscular strength assessed at baseline and week 12: 1. Upper-body muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of 2 different exercise tests, including: - Sum of right and left unilateral isometric seated bench press. Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). - Sum of right and left unilateral isometric seated row. Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). 2. Lower-body muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of 2 different exercise tests, including: - Sum of right and left unilateral isometric knee extension in closed kinetic chain at 90º (average of the right and left knees). Muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). - Mid-thigh isometric pull test. Bilateral muscular strength will be measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). 3. Overall muscular strength will be a standardized score computed as the average of the normalized score (z-score = [value-mean] / standard deviation) of the above-mentioned upper- and lower-body exercise tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and week 12: 1. Other Muscular strength measures: 1.1. Bilateral isometric seated bench press measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). 1.2. Isometric seated bench press bilateral deficit [bilateral deficit = (100 x bilateral / (right unilateral + left unilateral)) - 100]. 1.3. Bilateral isometric seated row measured in N with an electromechanical dynamometer (Dynasystem® Research, Symotech, Granada, Spain). 1.4. Isometric seated row bilateral deficit [bilateral deficit = (100 x bilateral / (right unilateral + left unilateral)) - 100]. 1.5. Handgrip strength (of the right and left sides) assessed with a digital dynamometer (Model T.K.K.540®; Takei Scientific Instruments Co., Ltd, Niigata, Japan). 1.6. The difference between right unilateral and left unilateral handgrip strength, assessed with a digital dynamometer (Model T.K.K.540®; Takei Scientific Instruments Co., Ltd, Niigata, Japan). 2. Cardiorespiratory fitness assessed through the Siconolfi Step Test. 3. Shoulder range of motion: flexion. Assessed through digital goniometer (HALO medical services). 4. Disabilities of the Arm, Shoulder, and Hand (DASH), assessed through the DASH Questionnaire. 5. Quality of life will be assessed with: 5.1 European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30, including the extension for breast cancer (EORTC QLQ-BR23). 5.2 Functional Assessment of Cancer Therapy-Breast (FACT-B). 6. Cancer-related fatigue, assessed with the functional assessment of cancer therapy-fatigue (FACT-F). 7. Depressive symptoms, assessed with the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D). 8. Life satisfaction, assessed with the Satisfaction with life scale (SWLS). 9. Body composition: 9.1 Weight (in kg) and body composition (including body fat percentage, fat-free mass (kg), etc.) will be assessed with a bioelectrical impedance device (InBody 120, InBody Co. Ltd., Seo | — |
Countries
Spain
Outcome results
None listed