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Table 2 Study outcome measure

From: A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol

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

  1. 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