Breast Cancer, Cancer Survivors
Conditions
Keywords
Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity, Quality of life
Brief summary
The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are: * Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants. * Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks. Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.
Interventions
OTHEROncological physical exercise intervention
An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested. Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity. Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.
OTHERActive Physical Activities intervention
An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.
Sponsors
Tigers Running Club
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Doesn´t exist. Patients were allocated depending their preferences
Intervention model description
control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype. * Women with chemotherapy and radiotherapy phase complete. * Women with post-surgery phase complete. * Women that are within 5 years from diagnostic. * ECOG Score above or equal to 0 or 1.
Exclusion criteria
* Submit medical contraindications to physical exercise by their reference doctor. * Women in state IV o methastasis. * Pregnant women. * Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular fitness | 16 weeks | Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical functionality | 16 weeks | Know the impact of the oncologic physical exercise program in the physical functionality of the patients. |
| Exercise adherence | 16 weeks | Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions. |
| Physical activity Levels | 16 weeks | Evaluate the effect of the intervention in the physical activity levels performed by the patients. |
| Body composition | 16 weeks | Analyze the effect of the oncologic physical exercise program in the body weight, the body mass index (BMI), percentages in body fat, abdominal fat, fat free mass, bone mass and total body water in breast cancer survivors. |
| Quality of life and health | 16 weeks | Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health. |
| Anxiety and depression levels | 16 weeks | Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects. |
| Fatigue levels | 16weeks | Evaluate the impact of the physical exercise program in the fatigue levels of the participants. |
Countries
Spain
Outcome results
None listed