POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorNere Mendizabal
About this trial
Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.
Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.
Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.
Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with cancer and other neoplasms
Age between 4 and 18 years at the time of inclusion in the study
Patients diagnosed with cancer and other malignancies aged between 4 and 18 years who are experiencing relapse
Paediatric patients requiring chemotherapy, radiotherapy, or oncological surgery
Disqualifiers
Patients with cognitive deficits that prevent participation in and performance of physical exercise interventions.
Patients with severe neurological pathology with a motor impairment that prevents or significantly hinders the performance of physical exercise
Patients and families or guardians with language comprehension difficulties that make it difficult or impossible to carry out the physical exercise intervention.
Patients < 16 years with a functional status score according to Lanskyi scale <60%
Trial design
Design model
Single group
Treatments tested in this trial
Physical exercise program
Other interventionAt least two sessions a week for a 6-month supervised and individualized physical exercise program that will have two phases: one that will be carried out in person in the hospital environment taking advantage of medical visits, and a second phase that will allow the patient to carry out the exercise sessions from home with live virtual supervision.
Type of the physical exercise program
Other interventionTwo types of intervention are proposed depending on the age of the patients: Exercise intervention for adolescents (12 to 18 years): training will be based on strength training (2 - 3 sets of 8 - 12 repetitions) with elastic bands, weights, weights, medicine balls or body weight and aerobic work on a stationary bike, treadmill or other aerobic exercises. Sessions will last about 30-60 minutes (depending on the patient's situation). Exercise intervention for children (4 to 11 years old): The aim will be to work on basic motor skills through play, thus trying to avoid the delay in motor development, and to indirectly work on their physical condition to better cope with the effects of the treatments. Music, games that require movement and materials such as balls, hoops, etc., will be used to motivate the child to move while enjoying themselves. This will be done in sessions of 20 - 40 minutes.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Quarterly recruitment rates assessed by comparing those who participate with those who do not.
To assess the feasibility of the exercise programme, quarterly recruitment rates will be calculated over the recruitment and follow-up period, and socio-demographic and morbidity variables associated with study participation will be identified, comparing those who participate with those who do not, using logistic regression analysis.
Time frame
2 years2
Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol
Participants' adherence to the programme will be described in terms of the proportion of sessions completed and compliance with the exercise protocol prescribed for each patient, and variables associated with compliance will be identified.
Time frame
2 years3
Body composition assessed by the Body Mass Index
Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m\^2). Measured at baseline, and 3 months.
Time frame
2 years4
Muscle mass
Muscle mass will be measured in kgs by a bioimpedance scale. Measured at baseline, and 3 months.
Time frame
3 monthsSecondary outcomes
1
Security assessment
To assess the safety of this new exercise programme by describing the occurrence of injuries, incidence of complications.
Time frame
2 years2
Costs associated estimation
Estimate the costs associated with the implementation of the programme.
Time frame
3 years3
Implementation barriers and facilitators
Describe the most important difficulties encountered in its implementation, identify barriers and facilitating factors for its implementation and realisation with minimum quality criteria, using the Consolidated Framework for Implementation Research (CFIR) as a theoretical framework for implementation.
Time frame
2 yearsLocations
Sponsors and contacts
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Nere Mendizabal
Lead sponsor
Basque Health Service
Sponsor institution
Source ClinicalTrials.gov
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