Cancer
Conditions
Keywords
pediatrics, oncology
Brief summary
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.
Interventions
Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.
OTHERTherapeutic physical exercise + electrotherapy
Specific 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.
OTHERTherapeutic physical exercise + gamified game
Specific 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.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Three intervention arms: 1. Therapeutic physical exercise 2. Therapeutic physical exercise + electrotherapy 3. Therapeutic physical exercise + gamified game
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Patients with sufficient physical capacity to tolerate the activities proposed by the program.
Exclusion criteria
* 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. * Participation in other clinical trials: patients already involved in other research that could interfere with the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strength | 6 month | Lower-limb 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. Upper-limb strength: Handgrip strength measured using a Stabilizer pressure biofeedback device: is a measure of upper-limb isometric strength in which the participant compresses the pressure device with the hand to generate the maximum possible pressure. The assessment is performed separately for the right and left hands, and the maximum pressure generated is recorded in millimeters of mercury (mmHg). Higher values indicate greater handgrip strength. |
| Cardiorespiratory function | 6 month | 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 | 6 month | Physical Activity Self-Efficacy Scale (AEF): is a self-report measure designed to assess the participant's perceived confidence in their ability to engage in physical activity. The scale evaluates how capable the child or adolescent feels of performing physical activity in different situations. If reported using a numerical score, the total score ranges from 0 to 10, where 0 represents the lowest level of perceived self-efficacy and 10 represents the highest level. Higher scores indicate greater perceived self-efficacy for physical activity. |
| Pain level | 6 month | Visual Analog Scale (VAS) and Chronic Pain Grade Scale (CPGS): pain is assessed using complementary measures of pain intensity and its impact. The VAS is a simple, widely used measure for assessing subjective pain intensity. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end, from 0 = "no pain" to 10 = "worst imaginable pain." The respondent marks the point that best represents their perceived pain intensity. The CPGS is used to assess chronic pain severity, considering pain intensity and its associated impact on daily functioning. When pain intensity is reported numerically, scores range from 0 to 10, with 0 representing no pain and 10 representing the highest pain intensity. Higher scores indicate greater pain severity and impact. |
| Balance | 6 month | Pediatric Berg Balance Scale (BBS): is a performance-based assessment designed to measure functional balance in children through 14 tasks such as standing, turning, and reaching. Each item is scored from 0 (inability to perform) to 4 (independent, best performance), producing a minimum total score of 0 and a maximum of 56. Higher scores indicate better balance ability and greater functional stability. |
| Ankle dorsiflexion ROM | 6 month | Goniometer: is an instrument used to measure the range of motion (ROM) of a joint. For ankle dorsiflexion, the goniometer is positioned with the axis at the lateral malleolus, the stationary arm aligned with the fibula, and the movable arm along the fifth metatarsal. Measurements are reported in degrees, with a typical minimum of 0° and a maximum depending on the individual, usually around 20° for dorsiflexion. Higher values indicate greater ankle dorsiflexion ROM, reflecting better joint flexibility. |
| Weight | 6 month | Tanita DC-430 MA |
| Height | 6 month | Harpender stadiometer |
| BMI | 6 month | weight/height 2 |
| Muscle circumferences (upper arm, waist, hip, and thigh) | 6 month | Tape measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-related fatigue | 6 month | 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 | 6 month | 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 | 6 month | Depressive and anxiety 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 a minimum total score of 0 and a maximum total score of 54. Higher scores indicate more severe depressive symptoms. The Childhood Anxiety Sensitivity Index (CASI) is a self-report measure that evaluates 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 0 and a maximum of 54. Higher scores reflect greater anxiety sensitivity. The State-Trait Anxiety Inventory for Children (STAIC) is a self-report questionnaire designed to assess anxiety in children and adolescents through two separate dimensions: state anxiety, which reflects transient anxiety experienced at a particular moment, and trait anxiety, which reflects a relatively stable tendency to ex |
| Sleep | 6 month | Pediatric Sleep Questionnaire (PSQ): is a parent- or caregiver-reported tool used to screen for sleep-related problems in children, including sleep-disordered breathing, snoring, and daytime sleepiness. Items are typically scored as "Yes" = 1, "No" = 0, or "Don't know" = missing. The total score is calculated as the proportion of positive responses, with a minimum of 0 and a maximum of 1. Higher scores indicate more sleep-related problems. |
| Kinesiophobia | 6 month | Kinesiophobia Questionnaire for Children (KQC) adapted from the Tampa Scale for Kinesiophobia (TSK): is a self-report instrument designed to assess fear of movement or reinjury in children. Items are typically scored on a 4-point Likert scale (1 = "Strongly Disagree" to 4 = "Strongly Agree"), with a minimum total score of 11 and a maximum of 44. Higher scores indicate greater kinesiophobia, reflecting a stronger fear of movement or activity due to pain or injury. |
| Treatment Adherence | 6 month | Exercise Adherence Rating Scale: is a self-report questionnaire used to assess an individual's adherence to prescribed exercise programs. Items are typically scored on a 5-point Likert scale (0 = "Completely Disagree" to 4 = "Completely Agree"), with a minimum total score of 0 and a maximum of 24 for the adherence section. Higher scores indicate better adherence to the exercise regimen. |
| Social Support | 6 month | Social support: The Social Support Questionnaire for Children (SAQ-C24) is a self-report questionnaire designed to assess perceived social support in children and adolescents across relevant interpersonal and social contexts. It consists of 24 items, providing a total score ranging from 0 to 96. Higher scores indicate greater difficulties or poorer perceived social support, whereas lower scores reflect a more favorable perception of social support. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMANOLO M ALBORNOZ CABELLO, FISIOTERAPEUTA
FACULTAD DE ENFERMERÓIA, FISIOTERAPIA Y PODOLOGÍA
Outcome results
None listed