Analysis of a Multimodal Physiotherapy Treatment in Pediatric and Adolescent Cancer Survivors: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Seville
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Strength
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 16 Years (Child)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Strength
Time Frame: 6 month
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
Time Frame: 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
Time Frame: 6 month
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
Time Frame: 6 month
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.
BMI
Time Frame: 6 month
weight/height 2
Balance
Time Frame: 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
Time Frame: 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
Time Frame: 6 month
Tanita DC-439 MA
Height
Time Frame: 6 month
Harpender stadiometer
Bone mineral density
Time Frame: 6 month
Ultrasound (QUS Model: Bone Mineral Densiometer, (OSTEOSYS, BETTER PRODUCTS FOR BETTER LIFE, n.d.))
Muscle circumferences (upper arm, waist, hip, and thigh)
Time Frame: 6 month
Tape measure
Secondary Outcomes
- Physical activity levels(6 month)
- Cancer-related fatigue(6 month)
- Cancer-related Quality of life(6 month)
- Anxiety-depressive symptoms(6 month)
- Sleep(6 month)
- Kinesiophobia(6 month)
- Treatment Adherence(6 month)
- Social Support(6 month)
Investigators
Miriam Linero Bocanegra
Physiotherapy
University of Seville