The investigators will study the effects of an supevised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukemias\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed--or relapse of-- a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/≤2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial. The intervention group will follow a supervised concurrent exercise program from the start to the end of intensive treatment. The exercise intervention will be performed in the hospital gymnasium or in the patients' ward (during neutropenic phases), and will also include supervised online sessions. Additionally, the intervention group will perform include inspiratory muscle training. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiography-determined variables, cardiac biomarkers, blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory markers, plasma proteome, gut microbiome, and immune function).
Background. Health promotion interventions are needed during adolescent cancer treatment to facilitate the acquisition of good health practices as patients transition to survivorship. Although meta-analytical evidence supports the health benefits of exercise in the context of childhood cancer, there is scant data focusing solely on adolescents. Hypothesis and objectives. The investigators hypothesise that a supervised exercise intervention combined with lifestyle counselling during treatment for adolescent cancer will provide several health benefits, particularly related to the cardiometabolic profile. Thus, the investigators will study the effects of a supervised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukaemias\], expected median duration 5-6 months) on several health-related variables. Setting and Methods. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with (or having relapse of) a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/≤2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial (1:1 ratio randomisation with a block on gender and tumour type \[leukaemias/lymphomas\]). In addition to usual care, the two groups will receive health counselling twice a month (i.e., psychological intervention based on motivational interviewing techniques, as well as guidance on heathy activity, sleeping, and dietary habits). The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium (3 sessions/week of aerobic and resistance exercises), except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include online sessions. Inspiratory muscle training (5 days/week) will be also performed. Patients in the control group will have the option to go to the hospital gymnasium twice a month (to perform playing activities) in order to maximize compliance to the study and to maintain contact with them. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiographic variables, cardiometabolic biomarkers, blood pressure, blood lipids, dual-energy X-ray absorptiometry-determined body composition (fat \[including visceral adipose tissue\]/lean mass, bone mineral content/density), energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables (survival, treatment tolerability, hospitalisation length), and potential biological underpinnings of exercise multisystemic benefits (cardiometabolic and inflammatory biomarkers, gut microbiome, and immune function \[lymphocyte subpopulations, natural killer cell cytotoxicity\]) (secondary outcomes).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
the intervention group will follow a supervised physical exercise intervention--see below. The exercise program (3 supervised sessions/week of aerobic and muscle strength exercises) will be performed: (a) in the hospital gymnasium, or (b) in the patients' room (during phases of treatment-induced immunodepression, where isolation is needed to prevent infections), or (c) online (for those unable to attend the hospital on that day/s). It will also include specific training of the respiratory ('inspiratory') muscles (e.g., diaphragm) on 5 days/week.
Universidad Europea de Madrid
Villaviciosa de Odón, Spain, Spain
RECRUITINGUEM
Madrid, Spain
RECRUITINGChange in left-ventricular (LV) function (LV ejection fraction) from baseline to end of treatment
Echocardiography-determined LV ejection fraction (unit = %)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular (LV) function (LV fractional shortening) from baseline to end of treatment
Echocardiography-determined LV fractional shortening (unit = %)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in global longitudinal strain (GLS) of the left ventricle from baseline to end of treatment
Echocardiography-determined GLS (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up
Echocardiography-determined LV ejection fraction (unit = %)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up
Echocardiography-determined LV fractional shortening (unit = %)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Change in global longitudinal strain (GLS) of the left ventricle from baseline to 3 months after the end of treatment (follow-up)
Echocardiography-determined GLS (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in 'clinic' arterial blood pressure from baseline to end of treatment
Arterial blood pressure (BP) (units = mmHg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Change in 'clinic' arterial blood pressure from baseline to follow-up
Arterial blood pressure (BP) (units = mmHg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in serum lipid profile (cholesterol) from baseline to end of treatment
Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Change in serum lipid profile (cholesterol) from baseline to follow-up
Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Change in serum lipid profile (triglycerides) from baseline to end of treatment
Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Change in serum lipid profile (triglycerides) from baseline to follow-up
Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
Change in adiposity index from baseline to end of treatment
Waist-to-hip ratio (no units)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in adiposity index from baseline to follow-up
Waist-to-hip ratio (no units)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)
Change in DXA measures of lean mass from baseline to end of treatment
DXA-determined total lean mass (grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in DXA measures of lean mass from baseline to follow-up
DXA-determined total lean mass (grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in DXA measures of fat mass from baseline to end of treatment
DXA-determined total fat mass (grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in DXA measures of fat mass from baseline to follow-up
DXA-determined total fat mass (grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in DXA measure of bone mineral density of the total body (less head) from baseline to end of treatment
DXA-determined subtotal bone mineral density (unit = g/cm2)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in DXA measure of bone mineral density of the total body (less head) from baseline to follow-up
DXA-determined subtotal bone mineral density (unit = g/cm2)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)
Change in cardiorespiratory fitness (VO2peak) from baseline to end of treatment
VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in cardiorespiratory fitness (VO2peak) from baseline to follow-up
VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank -for those participants missing a lower limb- ergometer test (units = mL/kg/min).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in muscle strength from baseline to end of treatment
The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press, as well as for seated lateral row, lateral pull down and knee extension (units = kg).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in muscle strength from baseline to follow-up
The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press, as well as for seatead lateral row, lateral pull down and knee extension (units = kg).
Time frame: Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)
Change in inspiratory muscle strength (PImax) from baseline to end of treatment
PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of ≥1 min-duration) taken.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in inspiratory muscle strength (PImax) from baseline to follow-up
PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of ≥1 min-duration) taken.
Time frame: Assessed at three time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Survival from baseline to follow-up
Number of days elapsed from diagnosis until the end of the study (or death, tumor recurrence, or transplant)
Time frame: Assessed from baseline (diagnosis) until 3 months after end of treatment (follow-up)
Treatment tolerability from baseline to end of treatment
Number of days of treatment interruption/delay
Time frame: Assessed from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in clinical variables (days of hospitalization) from baseline to end of treatment
Total hospitalisation length (number of days)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Change in clinical variables (global score of Common Terminology Criteria for Adverse Events [CTCAE]) from baseline to end of treatment
Common Terminology Criteria for Adverse Events \[CTCAE, global score, 1 (low toxicity) to 5 (highest)\]
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis.
Change in clinical variables (global score of Common Terminology Criteria for Adverse Events [CTCAE]) from baseline to follow-up
Common Terminology Criteria for Adverse Events \[CTCAE, global score, 1 (low toxicity) to 5 (highest\])
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment (follow-up)
Change in metabolic markers (glucose) from baseline to end of treatment
Serum fasting glycaemia (mg/dL)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Change in metabolic markers (glucose) from baseline to follow-up
Serum fasting glycaemia (mg/dL)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in metabolic markers (insulin) from baseline to end of treatment
Serum fasting insulinaemia (pmol/L)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in metabolic markers (insulin) from baseline to follow-up
Serum fasting insulinaemia (pmol/L)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in metabolic markers (HOMA-IR) from baseline to end of treatment
Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in metabolic markers (HOMA-IR) from baseline to follow-up
Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to end of treatment
High-sensitivity C-reactive protein (mg/L)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in chronic systemic inflammation (high-sensitivity C-reactive protein) from baseline to follow-up
High-sensitivity C-reactive protein (mg/L)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in plasma cardiovascular-related targeted proteome from baseline to end of treatment
Olink® cardiovascular II reagent kit, which measures 92 cardiovascular related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in plasma cardiovascular-related targeted proteome from baseline to follow-up
Olink® cardiovascular II reagent kit, which measures 92 cardiovascular related human protein biomarkers simultaneously (units = Normalized Protein Expression (NPX) values, Olink's arbitrary unit presented in log2 scale)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (i.e., follow-up)
Change in gut microbiome (alpha-diversity) from baseline to end of treatment
α-diversity
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in gut microbiome (alpha-diversity) from baseline to follow-up
α-diversity
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in gut microbiome (beta-diversity) from baseline to end of treatment
beta-diversity
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in gut microbiome (beta-diversity) from baseline to follow-up
Beta-diversity
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in gut microbiome (specific bacteria) from baseline to end of treatment
Changes in bacteria abundance
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in gut microbiome (specific bacteria) from baseline to follow-up
Changes in bacteria abundance
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in Immune phenotype (lymphocyte subpopulations) from baseline to end of treatment
Lymphocyte subpopulations (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis
Change in Immune phenotype (lymphocyte subpopulations) from baseline to follow-up
Lymphocyte subpopulations (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in Immune phenotype (natural killer (NK) cells) from baseline to end of treatment
NK cell subsets (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in Immune phenotype (NK cells) from baseline to follow-up
NK cell subsets (%)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in Immune function from baseline to end of treatment
NK cell receptors
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in immune function from baseline to follow-up
NK cell receptors
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to end of treatment
NT-proBNP (units = pg/mL)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from baseline to 3 months after the end of treatment (follow-up)
NT-proBNP (units = pg/mL)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in cardiac troponin I from baseline to end of treatment
Cardiac troponin I (units = ng/mL)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in cardiac troponin I from baseline to 3 months after the end of treatment (follow-up)
Cardiac troponin I (units = ng/mL)
Time frame: : Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in left-ventricular (LV) mass from baseline to end of treatment
Echocardiography-determined LV mass (unit = grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular (LV) mass from baseline to follow-up
Echocardiography-determined LV mass (unit = grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) and (2) 3 months after the end of treatment (follow-up)
Change in relative wall thickness (RWT) from baseline to end of treatment
Echocardiography-determined RWT (units = cm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in relative wall thickness (RWT) from baseline to follow-up
Echocardiography-determined RWT (units = cm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in DXA measures of visceral adipose tissue (VAT) from baseline to end of tratment
DXA-determined VAT (unit = grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in DXA measures of visceral adipose tissue (VAT) from baseline to follow-up
DXA-determined VAT (grams)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in serum lipid profile (apolipoprotein B) from baseline to follow-up
Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in serum lipid profile (apolipoprotein B) from baseline to end of treatment
Apolipoprotein B will be quantified with an automated chemistry analyser (units = mg/dL).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]
Change in handgrip strength from baseline to end of treatment
Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in handgrip strength from baseline to follow-up
Handgrip strength will be measured in both dominant and non-dominant arm (units = kg).
Time frame: Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up)
Change in interventricular septum thickness (IVS) from baseline to end of treatment
Echocardiography-determined IVS (units = mm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in interventricular septum thickness (IVS) from baseline to 3 months after the end of treatment (follow-up)
Echocardiography-determined IVS (mm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in left-ventricular end-diastolic diameter (LVEDD) from baseline to end of treatment
Echocardiography-determined LVEDD (mL)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular LV end-diastolic diameter (LVEDD) from baseline to 3 months after the end of treatment (follow-up)
Echocardiography-determined LVEDD (mL)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in left-ventricular posterior wall thickness (LVPW) from baseline to end of treatment
Echocardiography-determined LVPW (mm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular posterior wall thickness (LVPW) from baseline to 3 months after the end of treatment (follow-up)
Echocardiography-determined LVPW (mm)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in functional mobility (Timed Up and Go (TUG)) test) from baseline to end of treatment
Performance in TUG test (seconds)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in functional mobility (Timed Up and Go (TUG)) test) from baseline 3 months after the end of treatment (follow-up)
Performance in TUG test (seconds)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in functional mobility (Timed Up and Down Stairs (TUDS)) from baseline to end of treatment
Performance in TUDS test (units = seconds)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in functional mobility (Timed Up and Down Stairs (TUDS) test) from baseline 3 months after the end of treatment (follow-up)
Performance in TUDS test (seconds)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in functional mobility (30-second chair stand test) from baseline to end of treatment
Performance in 30-second chair stand test (unit = number of repetitions)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in functional mobility (in 30-second chair stand test) from baseline 3 months after the end of treatment (follow-up)
Performance in in 30-second chair stand test (units = number of repetitions)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in health-related quality of life (HRQoL) from baseline to end of treatment
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Patient's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in health-related quality of life (HRQoL) from baseline 3 months after the end of treatment (follow-up)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Patient's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in fatigue from baseline to end of treatment
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Patient's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in fatigue from baseline 3 months after the end of treatment (follow-up)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Patient's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in energy and nutrient intake from baseline to end of treatment
Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in grams) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in energy and nutrient intake from baseline 3 months after the end of treatment (follow-up)
Energy (total kcal/day) and substrate (carbohydrate, fat, protein, all in grams) intake, as estimated using the Nutrimind software based on the participants' reported food consumption frequencies in questionnaires
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in body mass index (BMI) from baseline to end of treatment
BMI (weight (kg)/height squared (m2))
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in body mass index (BMI) from baseline to follow-up
BMI (weight (kg)/height squared (m2))
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)
Change in DXA measure of bone mineral density of the femoral neck from baseline to end of treatment
DXA-determined bone mineral density of the femoral neck (unit = g/cm2)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment).
Change in DXA measure of bone mineral density of the femoral neck from baseline to follow-up
DXA-determined total bone mineral density of the femoral neck (unit = g/cm2)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up)
Change in peak power output (also known was 'peak work capacity') from baseline to end of treatment
Peak power output will be determined using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in in peak power output (also known was 'peak work capacity') from baseline to follow-up
Peak power output will be determined using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in the power output eliciting the 'ventilatory threshold' from baseline to end of treatment
The ventilatory threshold will be visually determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)]
Change in the power output eliciting the 'ventilatory threshold' from baseline to follow-up
The ventilatory threshold will be visually determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like cycle- or crank-ergometer-for those participants missing a lower limb-test (units = watts/kg)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in health-related quality of life (HRQoL) from baseline to end of treatment
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Parent's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in health-related quality of life (HRQoL) from baseline 3 months after the end of treatment (follow-up)
Paediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module (Parent's version), designed to measure paediatric/adolescent cancer specific HRQoL (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in fatigue from baseline to end of treatment
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Parent's version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in fatigue from baseline 3 months after the end of treatment (follow-up)
Cancer-related fatigue (Paediatric Quality of Life (PedsQL)) Multidimensional Fatigue Scale, Parents' version (0 to 100 scale, with higher scores indicating better HRQoL). Units = 0 to 100.
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the range of movement (ROM) of the ankle in the relaxed position from baseline to end of treatment
Ankle's ROM in the relaxed position will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the range of movement (ROM) of the ankle in the relaxed position from baseline to follow-up
Ankle's ROM in the relaxed position will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow- up)
Change in the range of movement (ROM) of the ankle at dorsiflexion from baseline to end of treatment
Ankle's ROM at dorsiflexion will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the range of movement (ROM) of the ankle at dorsiflexion from baseline to follow-up
Ankle's ROM at dorsiflexion will be assessed using a goniometer, except for those patients with an amputated ankle or a tumor next to the ankle (units = º)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
Change in the physical activity levels from baseline to end of treatment
Physical activity levels will be measured with the 'Youth Activity Profile' (YAP) questionnaire
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the physical activity levels from baseline to follow-up
Physical activity levels will be measured with the 'Youth Activity Profile' (YAP) questionnaire
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Change in the physical activity levels from baseline to end of treatment
Physical activity levels will be measured with the 'Assessment of Physical Activity Levels' (APAL) questionnaire (units = score from 5 to 20)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the physical activity levels from baseline to follow-up
Physical activity levels will be measured with the 'Assessment of Physical Activity Levels' (APAL) questionnaire (units = score from 5 to 20)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Change in the number of viral/bacterial/fungal infections from baseline to end of treatment
The number of viral/bacterial/fungal infections will be retrieved from medical records
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the number of viral/bacterial/fungal infections from baseline to follow-up
The number of viral/bacterial/fungal infections will be retrieved from medical records
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
Change in metabolic markers (glycated hemoglobin) from baseline to end of treatment
Serum fasting glycated hemoglobin (mmol/mol)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in metabolic markers (glycated hemoglobin) from baseline to follow-up
Serum fasting glycated hemoglobin (mmol/mol)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Change in left-ventricular (LV) hypertrophy from baseline to end of treatment
Age-specific \>95th percentile for LV mass
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in left-ventricular (LV) hypertrophy from baseline to follow-up
Age-specific \>95th percentile for LV mass
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Change in VO2 at the ventilatory threshold from baseline to end of treatment
VO2 at the ventilatory threshold will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in VO2 at the ventilatory threshold from baseline to follow-up
VO2 at the ventilatory threshold will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like bicycle- or arm-crank ergometer -for those participants missing a lower limb- test (units = mL/kg/min)
Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment
Change in toxicity grade from baseline to end of treatment
Toxicity grade will be assessed using the formula from Langlais et al (2022), where using the 5 adverse events of higher grade, provides a score from 5 (more toxicity) to 0 (less toxicity)
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in toxicity grade from baseline to follow-up
Toxicity grade will be assessed using the formula from Langlais et al (2022), where using the 5 adverse events of higher grade, provides a score from 5 (more toxicity) to 0 (less toxicity)
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
Change in the duration of viral/bacterial/fungal infections from baseline to end of treatment
The duration of viral/bacterial/fungal infections will be retrieved from medical records
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in the duration of viral/bacterial/fungal infections from baseline to follow-up
The duration of viral/bacterial/fungal infections will be retrieved from medical records
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 3 months after the end of treatment
Adherence to the exercise intervention from baseline to end of treatment
The number of attended exercise sessions
Time frame: Assessed continuously (every day) from baseline (diagnosis) until 14 to 28 weeks after diagnosis (i.e., end of treatment)
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