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Not yet recruiting NCT07301684

Physiotherapy in Pediatric Oncology

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic physical exercise, Therapeutic physical exercise + electrotherapy, Therapeutic physical exercise + gamified game.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: 3 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Analysis of a Multimodal Physiotherapy Treatment in Pediatric and Adolescent Cancer Survivors: A Randomized Clinical Trial

Overview

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

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

Primary outcome measures

  • Strength [Time frame: 6 month]
  • Cardiorespiratory function [Time frame: 6 month]
  • Physical activity self-efficacy [Time frame: 6 month]
  • Pain level [Time frame: 6 month]
  • Balance [Time frame: 6 month]
  • Ankle dorsiflexion ROM [Time frame: 6 month]
  • Weight [Time frame: 6 month]
  • Height [Time frame: 6 month]
  • BMI [Time frame: 6 month]
  • Bone mineral density [Time frame: 6 month]
Secondary outcome measures (8)
  • Physical activity levels [Time frame: 6 month]
  • Cancer-related fatigue [Time frame: 6 month]
  • Cancer-related Quality of life [Time frame: 6 month]
  • Anxiety-depressive symptoms [Time frame: 6 month]
  • Sleep [Time frame: 6 month]
  • Kinesiophobia [Time frame: 6 month]
  • Treatment Adherence [Time frame: 6 month]
  • Social Support [Time frame: 6 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Facultad de Enfermería, Fisioterapia y Podología — Seville

Identifiers

NCT: NCT07301684 · 01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗