Onco Move - Improvement of Psychophysical Fitness in Adult Cancer Survivors

HRQOL will be assessed pre-, post-intervention, and at follow-up using validated questionnaire: European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-Core 30 (EORTC QLQ-C30).

This instrument measures general quality of life and includes multiple subscales (e.g. physical, emotional, cognitive functioning). Scores on each scale range from 0 to 100.

• For functional scales and global health status, higher scores indicate better functioning or QoL.
• For symptom scales/items, higher scores indicate more severe symptoms (i.e. worse outcomes).

Data will be collected via digital or paper formats and analyzed. Statistical methods include repeated measures ANOVA and linear mixed-effects models to detect changes over time. Missing data will be handled via multiple imputation. This approach provides a comprehensive assessment of psychological and functional well-being related to the intervention.

The FSFI is a 19-item validated questionnaire measuring female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36, with higher scores indicating better sexual function.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

The IIEF is a 15-item questionnaire assessing male sexual function, including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Scores range from 5 to 75, with higher scores indicating better sexual function. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

UMACL measures three mood dimensions: tense arousal, energetic arousal, and hedonic tone. Scores vary by subscale; higher scores indicate greater presence of the respective mood state. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

KPS assesses perceived psychosocial stress across domains such as work and emotional strain. Scores vary by domain; higher scores indicate greater perceived stress. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

PHQ-4 is a 4-item screening tool with two items each for anxiety and depression. Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

NEO-FFI assesses five personality traits: Neuroticism, Extraversion, Openness, Agreeableness, and Conscientiousness. Each trait is scored separately; higher scores indicate stronger presence of the trait. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

STAI includes two 20-item subscales measuring state anxiety (temporary) and trait anxiety (long-term). Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Lower limb strength will be measured using the Chair Stand Test, included in both the Short Physical Performance Battery (SPPB) and the Senior Fitness Test (SFT). Participants are asked to rise from a chair without using their arms, either completing five repetitions as fast as possible (SPPB) or as many repetitions as possible in 30 seconds (SFT). Higher scores indicate better lower body strength and functional independence. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Upper limb strength will be assessed using the Arm Curl Test from the SFT. Participants perform as many bicep curls as possible in 30 seconds using standardized weights (2.3 kg for women and 3.6 kg for men). The number of repetitions is recorded. Higher scores indicate greater upper body muscular strength.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Flexibility will be assessed using two tests from the Senior Fitness Test (SFT):

• The Toe Touch (Sit-and-Reach) Test measures lower body flexibility.
• The Back Scratch Test measures upper body (shoulder) flexibility. Reach distances are recorded in centimeters, with positive values indicating the participant reaches beyond the target point. Higher values indicate greater flexibility.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Aerobic capacity will be assessed using one of the two tests from the Senior Fitness Test (SFT), selected based on the participant's fitness level:

• The 6-Minute Walk Test records the total distance walked in meters.
• The 2-Minute Step Test counts the number of knee lifts within 2 minutes. Both tests assess cardiovascular endurance. Higher values represent better aerobic capacity.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Balance and agility will be assessed using the 8-Foot Up-and-Go Test from the Senior Fitness Test (SFT). Participants stand up from a seated position, walk 8 feet (2.44 m), turn, return, and sit down. The time to complete the task is recorded in seconds. Lower times indicate better balance, agility, and risk reduction for falls.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Static balance will be assessed using the Standing Balance Test from SPPB. Participants are asked to maintain three progressively more challenging foot positions (side-by-side, semi-tandem, tandem) for up to 10 seconds each. The total score ranges from 0 to 4, with higher scores indicating better balance and lower fall risk.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Walking speed will be assessed using the 4-Meter Walk Test from SPPB. Participants walk 4 meters at their usual pace. Time is recorded and speed is calculated in meters per second. Higher speeds indicate better physical function and are associated with reduced fall risk and improved health outcomes.

Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Pain threshold will be evaluated at baseline, post-intervention, and follow-up using using the AlgoMed algometer, which applies calibrated pressure stimuli to assess the minimum pressure at which pain is perceived. Higher thresholds indicate lower pain sensitivity.

Data will be analyzed using repeated measures statistical models to detect changes over time. This multimodal assessment captures both sensory and experiential aspects of pain, providing a comprehensive profile of pain sensitivity and adaptation to the intervention.

Pain tolerance will be measured using the AlgoMed algometer, defined as the maximum pressure tolerated before pain becomes intolerable. Higher tolerance values indicate better pain endurance. Measurements will be taken at baseline, post-intervention, and follow-up.

Data will be analyzed using repeated measures statistical models to detect changes over time. This multimodal assessment captures both sensory and experiential aspects of pain, providing a comprehensive profile of pain sensitivity and adaptation to the intervention.

Subjective pain intensity will be rated by participants using the Visual Analogue Scale (VAS), a 100-mm horizontal line where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Higher scores indicate greater pain intensity. Assessments will occur at baseline, post-intervention, and follow-up.

Data will be analyzed using repeated measures statistical models to detect changes over time. This multimodal assessment captures both sensory and experiential aspects of pain, providing a comprehensive profile of pain sensitivity and adaptation to the intervention.

Pain characteristics will be assessed using the Laitinen Pain Scale, which evaluates four dimensions: pain intensity, frequency, use of analgesics, and limitations in physical activity. Participants rate each dimension on a scale from 0 to 4, with higher scores indicating greater severity or frequency. The total score is the sum of these four ratings, with a maximum possible score of 16. Assessments will occur at baseline, post-intervention, and follow-up.

Data will be analyzed using repeated measures statistical models to detect changes over time. This multimodal assessment captures both sensory and experiential aspects of pain, providing a comprehensive profile of pain sensitivity and adaptation to the intervention.

Body weight will be measured using a bioimpedance analyzer (InBody 720). Units: Kilograms (kg)

Body fat percentage will be measured using the InBody 720 bioimpedance analyzer, which estimates the proportion of fat mass relative to total body weight. Measurements will be taken at baseline, post-intervention, and follow-up to evaluate changes in adiposity.

Units: Percentage (%)

Skeletal muscle mass will be measured by the InBody 720 bioimpedance analyzer, providing an estimate of the muscle tissue mass in kilograms. Measurements at baseline, post-intervention, and follow-up will assess changes in muscle composition.

Units: Kilograms (kg)

BMI will be calculated using the participant's weight and height measured or recorded during the study. BMI reflects the body mass relative to height squared (kg/m²). Changes in BMI will be assessed at baseline, post-intervention, and follow-up.

Units: kg/m²

Visceral fat area, representing the fat surrounding internal organs, will be estimated by the InBody 720. Measurements at baseline, post-intervention, and follow-up will be used to monitor changes.

Units: cm²

Self-reported physical fitness will be assessed at baseline using the International Fitness Scale (IFIS), a validated questionnaire measuring perceived fitness across five domains: general fitness, cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Each item is rated on a 5-point Likert scale from 1 (very poor) to 5 (very good). Higher scores indicate better perceived fitness. The total score is the mean or sum of item responses, depending on analysis strategy.

Data will be collected digitally or on paper. Descriptive statistics and correlation analyses will be used to compare IFIS scores to objective measures from the InBody 720 bioimpedance analyzer, to assess alignment between subjective and objective fitness evaluations.

Balance and postural stability will be assessed using the BIODEX Stabilometric Platform. This device objectively measures static and dynamic balance, overall stability, and controlled mobility. Measurements will be taken at baseline, post-intervention, and follow-up to monitor changes in postural control and balance performance.

Neuromuscular performance will be evaluated using the Biodex System 4 Pro, an advanced dynamometric system for assessing and training muscle function under various contraction modes. The device allows for testing in isometric, isotonic (concentric and eccentric), isokinetic (concentric and eccentric), reactive eccentric, and passive motion conditions. It provides objective data on muscle strength, endurance, and control, with full data archiving and export capabilities for statistical analysis. Measurements will be conducted at baseline, post-intervention, and follow-up to detect changes in neuromuscular function over time.

Cardiopulmonary capacity will be evaluated using the Jaeger Oxycon Pro stationary ergospirometer, which analyzes exhaled gases during exercise to assess respiratory and circulatory function. The device uses precise O2 and CO2 analyzers to conduct Breath-by-Breath (3B) analysis, providing detailed functional assessments of the cardiovascular and pulmonary systems. Key parameters measured include maximum oxygen uptake (VO2 max), peak oxygen uptake (VO2 peak), ventilatory response to exercise (VE/VCO2 slope), and the respiratory exchange ratio (RER = VCO2/VO2), which is useful for evaluating anaerobic metabolism during exercise. These measurements will be taken at baseline, post-intervention, and follow-up to assess improvements in cardiorespiratory fitness.

Jumping ability and lower limb power will be assessed using the Kistler Model 9286BA dynamometric platform with MARS software. The platform, equipped with piezoelectric sensors, provides kinetic analysis of ground reaction forces during static and dynamic activities. It measures static body postural forces in a standing position, as well as dynamic forces during walking, running, and jumping. The platform captures both vertical and horizontal components of ground reaction forces during the support phase, enabling the evaluation of lower limb power, explosive strength, and maximal jump performance (e.g., vertical jump height and maximum power output). Measurements will be taken at baseline, post-intervention, and follow-up to assess changes in lower limb performance.

Grip strength will be measured using the SAEHAN electronic dynamometer with Herkules software. This device evaluates hand muscle strength by measuring grip force in an isometric test. The dynamometer features a five-level adjustable grip (ranging from 3.4 cm to 8.5 cm) to accommodate different hand sizes. The measurements will be taken at baseline, post-intervention, and follow-up to track changes in muscle strength and hand function.

Blood lactate concentration will be measured using the Lactate Scout 4 system. This device is designed for assessing lactate levels in capillary blood, providing insights into changes in physical fitness and endurance.

Lactate levels will be measured by finger prick during the exercise test. A baseline assessment will be performed 5-7 minutes before the start of the test, then levels will be checked during the warm-up and twice during the exercise phase. Subsequent tests will be performed 2 and 5 minutes after the end of exercise. The test will be performed before the Onco-Move training intervention and after participation in 16 weeks of training (lactate levels tested seven times during each test).

IL-6 concentration will be measured in blood samples collected at baseline, post-intervention, and follow-up to assess inflammatory response. IL-6 is a pro-inflammatory cytokine associated with exercise-induced immune modulation.

Units: pg/mL

IL-15 will be measured to evaluate immune and metabolic responses to the intervention. This cytokine plays a role in skeletal muscle metabolism and immune signaling.

Units: pg/mL

Irisin levels will be assessed as a biomarker of exercise-induced metabolic activity and browning of adipose tissue.

Units: ng/mL

BDNF will be measured to assess neuroplasticity and cognitive adaptations in response to the intervention. It is involved in neuronal survival, development, and synaptic plasticity.

Units: ng/mL

SPARC will be assessed to evaluate its role in exercise-induced muscle adaptation and extracellular matrix remodeling.

Units: ng/mL

Decorin will be analyzed as a marker of muscle regeneration and anti-fibrotic activity post-intervention.

Units: ng/mL

Polymorphisms in the Angiotensin-Converting Enzyme (ACE) gene will be analyzed using blood samples to assess associations with cardiorespiratory and muscular adaptation to the intervention. Genotypes (e.g., I/I, I/D, D/D) will be reported.

Unit of Measure: Proportion of participants with each genotype

The ACTN3 polymorphism will be analyzed to explore associations with muscle strength and endurance performance.

Unit of Measure: Proportion of participants with each genotype

Polymorphisms in the Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alpha (PPARGC1A) gene will be examined for associations with mitochondrial function and metabolic adaptation.

The BDNF Val66Met polymorphism will be genotyped to assess its role in neuroplasticity and mood changes in response to the intervention.

Unit of Measure: Proportion of Val/Val, Val/Met, and Met/Met genotypes

Polymorphisms in the VEGF gene will be analyzed to explore associations with vascular adaptation.

Unit of Measure: Proportion of genotype variants

The IL6 polymorphisms will be assessed for its role in inflammatory response to the intervention.

Unit of Measure: Proportion of G/G, G/C, and C/C genotypes

NOS3 will be evaluated in relation to endothelial function and exercise response.

Unit of Measure: Proportion of G/G, G/T, and T/T genotypes

HIF1A will be assessed for potential links with hypoxia tolerance and metabolic response.

Unit of Measure: Proportion of Pro/Pro, Pro/Ser, and Ser/Ser genotypes

The TNF-α will be genotyped to examine inflammatory regulation. Unit of Measure: Proportion of G/G, G/A, and A/A genotypes

Selected polymorphisms in genes from the mTOR pathway will be analyzed for associations with metabolic and muscular adaptation.

Unit of Measure: Proportion of genotype variants

Telomere length and telomerase activity will be measured using qPCR or ELISA-based assays to evaluate cellular aging over the course of the intervention.

Unit of Measure:

• Telomere length: T/S ratio
• Telomerase activity: Units per µg protein

Adherence to a Mediterranean dietary pattern will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS), originally developed and validated in the PREDIMED trial. This questionnaire evaluates the frequency of consumption of key food components characteristic of the Mediterranean diet, such as olive oil, fruits, vegetables, legumes, nuts, fish, wine, and limits on red meat and processed foods. Each item is scored as 0 (does not meet the criterion) or 1 (meets the criterion), resulting in a total score ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet.

Unit of Measure: Score on a 0-14 scale