Table 2.
Study outcome measure
| Domain | Measure | Assessment Method | Timepoint from chemotherapy |
|---|---|---|---|
| Primary outcomes | |||
| Cardiotoxicity | Resting LVEF | TTE | Pre-post |
| Resting GLS | TTE | Pre-post | |
| Secondary outocomes | |||
| Cardiopulmonary function | VO2 peak | CPET | Pre-post |
| Biomarkers | NT- proBNP | Blood test | Pre-post |
| Troponin I | Blood test | Pre-post | |
| Hemoglobin | Blood test | Pre-post | |
| Body composition | % Body fat | Tanita | Pre-post |
| % Lean mass | Tanita | Pre-post | |
| Anthropometrics | Height | Height road | Pre |
| Weight | Tanita | Pre-post | |
| Abdominal circumference | Tape measure | Pre-post | |
| BMI | Database | Pre-post | |
| Vital signs | Heart rate | BPM | Pre-post |
| Blood pressure | BPM | Pre-post | |
| Cardiovascular risk factors | Dyslipidemia | Clinical history | Pre-post |
| Diabetes mellitus | Clinical history | Pre-post | |
| Arterial hypertension | Clinical history | Pre-post | |
| Smoking status | Clinical interview | Pre-post | |
| Limb strength | Lower limb strenght | 30-STS | Pre-post |
| Uper limb strenght | Handgrip dinamometry | Pre-post | |
| Upper limb function in women undergone surgery | Limb perimeters | Tape measure | Pre and/or post if surgery |
| Shoulder functional capacity | Goniometry | Pre and/or post if surgery | |
| Shoulder pain and disability | SPADI | Pre and/or post if surgery | |
| Psychometric and lifestyle questionnaires | Anxiety and depression | HADS | Pre-post |
| Health-related quality of life | FACT-B + 4 | Pre-post | |
| Level of physical activity | GLTEQ | Pre-post | |
| Adherence mediterranean diet | PREDIMED | Pre-post | |
| Exploratory outcomes | |||
| Physical exercise | Minutes of In- (EG) and out- (both groups) of-hospital dedicated exercise | Exercise diary | Post |
| Safety of the intervention | Adverse events during exercise and clinical serious adverse events | Medical history and reported information | Post |
| Supervised exercise program | Adherence and compliance | Attendance register | Post |
| Expectations | Open question | Post | |
| Satisfaction | 9-item questionnaire | Post | |
LVEF left ventricular ejection fraction, GLS global longitudinal strain, TTE transthoracic echocardiography, CPET cardiopulmonary exercise test, NT- proBNP N-terminal brain natriuretic propeptide, BMI body mass index, BPM blood pressure monitor, SPADI shoulder pain and disability index, PREDIMED PREvención con DIeta MEDiterránea, FACT-B + 4 functional assessment of cancer therapy—breast plus arm morbidity, HADS hospital anxiety and depression scale, GLTEQ Godin Leisure Test Exercise Questionnaire, EG experimental group