About this trial
The objective of this clinical trial is to determine whether therapeutic physical exercise combined with electrotherapy and exercise gaming improves rehabilitation outcomes in pediatric and adolescent cancer patients.
The main questions it aims to answer are:
Does the combination of therapeutic physical exercise plus muscle strengthening and therapeutic physical exercise plus gamification, compared to a single exercise intervention, improve patient condition? Does gamified exercise improve treatment adherence? Does electrotherapy improve muscle activity when used in muscle strengthening mode? Researchers will test the application of the described modalities and assess improvements in variables such as cardiorespiratory fitness, physical activity self-efficacy, pain, balance, joint range of motion, physical activity level, cancer-related fatigue, quality of life, anxiety-depression, sleep, kinesophobia, and social status.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have completed cancer treatment and are currently in remission, referred by their oncologist.
Children and adolescents aged 3 to 16 years.
Patients with a stable medical condition, without severe or acute complications related to cancer or its treatments.
Patients whose informed consent (from parents/legal guardians, in this case, as they are minors) has been obtained to participate in this study.
Disqualifiers
Severe comorbidities: neuromuscular, cardiovascular, or respiratory diseases that prevent participation in the exercise program or interfere with the assessment of physical function.
Incompatible medical treatments: patients currently receiving active treatments or with medical contraindications for electrotherapy or participation in exercise programs.
Severe psychological issues: children with severe psychological disorders or cognitive disabilities that may hinder understanding and participation in the sessions.
Visual impairments: patients with visual problems will not be able to participate, as this may interfere with the analysis of results related to the use of devices and video games for exercise.
Trial design
Crossover
Treatments tested in this trial
Therapeutic physical exercise
Other interventionSpecific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.
Therapeutic physical exercise + electrotherapy
Other interventionSpecific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises. Combined with the application of electrical waves for neurostimulation of the quadriceps muscles.
Therapeutic physical exercise + gamified game
Other interventionSpecific therapeutic exercise intervention based on FITT parameters and focusing on aerobic, anaerobic, and breathing exercises. Combined with the application of gamified exercise to improve treatment adherence in these young populations.
Treatment groups
Trial outcomes
Primary outcomes
Strength
30-second sit-to-stand test to measure lower extremity muscle performance: is a functional measure of lower-limb strength in which an individual stands up and sits down from a chair as many times as possible within 30 seconds. If the test is reported using a numerical score, it corresponds to the total number of completed sit-to-stand repetitions, where the minimum value is 0, the maximum value depends on the person's performance, and higher scores indicate better lower-body strength and functional capacity.
Cardiorespiratory function
6-minute walk test: is a widely used assessment of cardiorespiratory function in which an individual is instructed to walk as far as possible along a flat, measured course for six minutes. When reported numerically, the score corresponds to the total distance walked in meters, with a minimum value of 0 meters, no fixed maximum (as it depends on individual performance), and higher distances indicating better cardiorespiratory capacity and endurance.
Physical activity self-efficacy
The five-item Physical Activity Self-Efficacy Scale (PASE): is a brief self-report measure that evaluates an individual's confidence in their ability to engage in physical activity under various challenging circumstances. Scores are obtained by summing responses to the five items, each typically rated on a scale from 1 (low confidence) to 5 (high confidence), yielding a minimum total score of 5 and a maximum of 25. Higher scores indicate better self-efficacy for maintaining physical activity.
Pain level
Visual Analog Scale (VAS): is a simple, widely used measure for assessing the intensity of subjective experiences such as pain, fatigue, or discomfort. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end-for example, 0 = "no pain" and 10 = "worst imaginable pain." The respondent marks a point on the line that represents their perceived intensity. The minimum score is 0, the maximum score is 10, and higher scores indicate a worse symptom intensity.
Secondary outcomes
Physical activity levels
Accelerometry Test: is an objective method for assessing physical activity levels by having an individual wear an accelerometer device, usually on the wrist, hip, or ankle, which records movement intensity and duration. Data are typically reported as average counts per minute, steps per day, or minutes spent in different activity intensities (e.g., sedentary, light, moderate, vigorous). Minimum values can be 0, and the maximum depends on the individual's activity level. Higher values indicate greater levels of physical activity.
Cancer-related fatigue
PedsQL™ Multidimensional Fatigue Scale: is a self-report questionnaire designed to assess fatigue in children across three domains: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Items are scored on a 5-point Likert scale (0 = "Never" to 4 = "Almost Always"), which are then reverse-scored and transformed to a 0-100 scale, with higher scores indicating less fatigue and better functioning. The minimum total score is 0, the maximum is 100, and higher scores reflect lower fatigue levels.
Cancer-related Quality of life
PedsQL™ Pediatric Quality of Life Questionnaire (Spanish version for Children and Adolescents with Heart Disease (PedsQL™)): is a self-report instrument that assesses health-related quality of life across multiple domains, including physical, emotional, social, and school functioning. Items are rated on a 5-point Likert scale (0 = "Never" to 4 = "Almost Always"), which are then reverse-scored and transformed to a 0-100 scale. The minimum total score is 0, the maximum is 100, and higher scores indicate better health-related quality of life.
Anxiety-depressive symptoms
The Children's Depression Inventory (CDI): is a self-report questionnaire designed to assess depressive symptoms in children and adolescents aged 8 to 18 years. It consists of multiple items scored on a 0-2 scale, with the minimum total score of 0 and a maximum total score of 54. Higher scores indicate more severe depressive symptoms. Childhood Anxiety Sensitivity Index (CASI): is a self-report measure that evaluates the fear of anxiety-related sensations in children. Items are rated on a 3-point scale (1 = "None" to 3 = "A lot"), with a minimum total score of 18 and a maximum of 54. Higher scores reflect greater anxiety sensitivity.
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