Physiotherapy in Pediatric Oncology

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Strength [Срок оценки: 6 month]
• Cardiorespiratory function [Срок оценки: 6 month]
• Physical activity self-efficacy [Срок оценки: 6 month]
• Pain level [Срок оценки: 6 month]
• Balance [Срок оценки: 6 month]
• Ankle dorsiflexion ROM [Срок оценки: 6 month]
• Weight [Срок оценки: 6 month]
• Height [Срок оценки: 6 month]
• BMI [Срок оценки: 6 month]
• Bone mineral density [Срок оценки: 6 month]

Вторичные конечные точки (8)

• Physical activity levels [Срок оценки: 6 month]
• Cancer-related fatigue [Срок оценки: 6 month]
• Cancer-related Quality of life [Срок оценки: 6 month]
• Anxiety-depressive symptoms [Срок оценки: 6 month]
• Sleep [Срок оценки: 6 month]
• Kinesiophobia [Срок оценки: 6 month]
• Treatment Adherence [Срок оценки: 6 month]
• Social Support [Срок оценки: 6 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Facultad de Enfermería, Fisioterapia y Podología — Seville

Идентификаторы

NCT: NCT07301684 · 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗