Physiotherapy in Pediatric Oncology

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-16
SponsorUniversity of Seville

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Therapeutic physical exercise

    Other intervention

    Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.

  • Therapeutic physical exercise + electrotherapy

    Other intervention

    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.

  • Therapeutic physical exercise + gamified game

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: GROUP EXERCISEActive comparator 1 intervention
Group B: GROUP ELECTROTHERAPYActive comparator 1 intervention
Group C: GROUP EXERGAMINGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 month
2

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.

Time frame
6 month
3

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.

Time frame
6 month
4

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.

Time frame
6 month

Secondary outcomes

1

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.

Time frame
6 month
2

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.

Time frame
6 month
3

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.

Time frame
6 month
4

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.

Time frame
6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: