Physiotherapy in Pediatric Oncology

University of Seville

Status: Not yet enrolling

Conditions: Cancer

Treatments: Other: Therapeutic physical exercise; Other: Therapeutic physical exercise + electrotherapy; Other: Therapeutic physical exercise + gamified game

Study type: Interventional

Funder types: Other

Identifiers

NCT07301684

01

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

GROUP EXERCISE

Active Comparator group

Treatment:

Other: Therapeutic physical exercise

GROUP ELECTROTHERAPY

Active Comparator group

Treatment:

Other: Therapeutic physical exercise + electrotherapy

GROUP EXERGAMING

Active Comparator group

Treatment:

Other: Therapeutic physical exercise + gamified game