ExercisePoziKidsNCT06321016
POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
A study testing Physical exercise program and Type of the physical exercise program in people with Exercise and Childhood Cancer, run by Nere Mendizabal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Exercise, Childhood Cancer
- What is being tested?
- Physical exercise program and Type of the physical exercise program
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Patients and parents or guardians who agree to participate in the study and sign the informed consent forms by current legislation depending on the patient's age.
Who cannot join
- 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%
- Patients > 16 years with Karnofsky scale <60%.
- Any other criteria that the physician deems inappropriate for participation in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Exercise, Childhood Cancer
- Being tested
- Physical exercise program, Type of the physical exercise program
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programOther
At 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 programOther
Two 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Muscle mass
Muscle mass will be measured in kgs by a bioimpedance scale. Measured at baseline, and 3 months.
Measured: 3 months
Bone mineral density
Bone mineral density will be in g/cm2 measured by a bioimpedance scale. Measured at baseline, and 3 months.
Measured: 3 months
Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer
The 6 minutes walking Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.
Measured: 3 months
Muscular strength assessed by manual grip test with a dynamometer
The manual grip test with a dynamometer applies to assess muscular strength. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.
Measured: 3 months
General Quality of life assessed by the PedsQL 4.0 questionnaire
The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The questionnaire is self-reported for children over 8 years old and self-reported by parents for children under 8 years old. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Measured: 3 months
Specific Quality of life assessed by the PedsQL cancer questionnaire
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module is a standard tool designed to assess the HRQOL among pediatric oncology patients. Consists of an instruction section and 27 items, contained in 8 dimensions. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Measured: 3 months
Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS)
The PedsQL™ Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. The appropriate questionnaire will be used depending on the age of the patients (Toddlers (2-4 years of age), Young Child (5-7 years of age), Child (8-12 years of age), Adolescent (13-18 years of age)). This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Measured: 3 months
Physical activity level assessed by accelerometers
Objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0 and 3 months
Measured: 3 months
Secondary outcomes (3)
Security assessment
To assess the safety of this new exercise programme by describing the occurrence of injuries, incidence of complications.
Measured: 2 years
Costs associated estimation
Estimate the costs associated with the implementation of the programme.
Measured: 3 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nere Mendizabal
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Nere Mendizabal, Basque Health Service
- Investigators
- Marta Menchaca Torio, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321016
- Sponsor's protocol ID
- 2023111039
- Acronym
- PoziKids
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
- ClinicalTrials.gov ID
- NCT06321016
- Acronym / sponsor ID
- PoziKids / 2023111039
- Conditions
- Exercise, Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nere MendizabalOther government
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Patients and parents or guardians who agree to participate in the study and sign the informed consent forms by current legislation depending on the patient's age.
Key exclusion criteria (6 listed)
- 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%
- Patients > 16 years with Karnofsky scale <60%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise programAt 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. | Other | – |
| Type of the physical exercise programTwo 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. | Other | – |
Primary outcome
Quarterly recruitment rates assessed by comparing those who participate with those who do not.
Time frame: 2 years
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.
Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol
Time frame: 2 years
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.
Body composition assessed by the Body Mass Index
Time frame: 2 years
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.
Muscle mass
Time frame: 3 months
Muscle mass will be measured in kgs by a bioimpedance scale. Measured at baseline, and 3 months.
Bone mineral density
Time frame: 3 months
Bone mineral density will be in g/cm2 measured by a bioimpedance scale. Measured at baseline, and 3 months.
Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer
Time frame: 3 months
The 6 minutes walking Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.
Muscular strength assessed by manual grip test with a dynamometer
Time frame: 3 months
The manual grip test with a dynamometer applies to assess muscular strength. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.
General Quality of life assessed by the PedsQL 4.0 questionnaire
Time frame: 3 months
The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The questionnaire is self-reported for children over 8 years old and self-reported by parents for children under 8 years old. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Specific Quality of life assessed by the PedsQL cancer questionnaire
Time frame: 3 months
The Pediatric Quality of Life Inventory (PedsQL) Cancer Module is a standard tool designed to assess the HRQOL among pediatric oncology patients. Consists of an instruction section and 27 items, contained in 8 dimensions. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS)
Time frame: 3 months
The PedsQL™ Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. The appropriate questionnaire will be used depending on the age of the patients (Toddlers (2-4 years of age), Young Child (5-7 years of age), Child (8-12 years of age), Adolescent (13-18 years of age)). This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.
Physical activity level assessed by accelerometers
Time frame: 3 months
Objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0 and 3 months
3 secondary outcomes
Security assessment
Time frame: 2 years
Costs associated estimation
Time frame: 3 years
Implementation barriers and facilitators
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Menchaca Torio principal investigator
Basque Health Service
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise program and Type of the physical exercise program in people with Exercise and Childhood Cancer, run by Nere Mendizabal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nere Mendizabal (+34946006637, nere.mendizabalgallastegui@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quarterly recruitment rates assessed by comparing those who participate with those who do not. (time frame: 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.