Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorTurku University Hospital

About this trial

The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. The research is carried out in cooperation with Turku University of Applied Sciences, Turku and Tampere University Hospitals. Cancer treatments significantly reduce the amount of PA of the child impairing the normal motor development. Delay in normal motor development may cause childhood cancer survivors a higher risk of developing adverse health effects in adulthood. Data on children's PA and condition is collected using questionnaires and sensors. In addition, children's motor performance and QoL are examined through tests and questionnaires. The feasibility of the intervention will be examined from the parents and nursing staff through questionnaires and interviews.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Digital tool for physical activity guidance and follow-up

    Behavioral

    Intervention length applied in this study varies according to participants cancer type and treatment period from 6 to 12 months. The intervention is carried out by mixed supervision. During the hospital visits supervision is carried out by experienced exercise physiotherapist together with the parents. During the home periods the supervision is carried out by EMPOWER mobile user interface. The recommended minimum three hours of PA a day for children consist of age appropriate activities of different ranges of intensity: 2 hours of light or brisk physical activity and one hour vigorous physical activity. Targeted single PA session duration is ≥30 min and the progression of the PA dose (exercise frequency, duration) and especially intensity, is expected to increase gradually up to 3 hours / day considering the child + parent self-evaluated daily condition.

  • Physical activity guidance

    Behavioral

    The intervention will be delivered by EMPOWER mobile UI for self reporting as well as guiding parents based on data. The application is adapted from an existing MyE.Way knowledge management system for holistic player development in team sports. EMPOWER mobile UI data collection and guidance system gives daily reminder to the parents about the daily PA recommendation. In addition, the families are provided with educational tips on useful games and activities leading to light, brisk, or vigorous PA. The tips are adjusted so that they can be completed during the cancer treatment either indoors or outdoors. The provided activities include education concerning the safety aspects regarding the child's cancer type and cancer treatment. As part of the intervention, children's daily pain, condition and exercise enjoyment, as well as child's readiness for exercise will be evaluated via the tool

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: EMPOWER interventionOther 2 interventions

Trial outcomes

Primary outcomes

1

Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.

Child's physical activity is measured daily by using the mobile EMPOWER user interface over the intervention. This tool has been created by Turku University of applied sciences for this study.

Time frame
From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
2

Age-appropriate motor skills are measured by Movement ABC measuring system

Motor skills are tested using Movement ABC-measuring system (version 3) monthly up to 3 months ande there after every 3 months (depending on the length of child's cancer treatment.

Time frame
From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
3

Quality of life of the child is measured by internationally validated Pedatric Quality of Life Inventory (PedsQoL)

Quality of life of the child is measured by using age-appropriate Generic Core scales of PedsQoL parent proxy forms.

Time frame
From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
4

Fibion SENS device is used for continuous measuring of the child's activity over 7 days.

Fibion SENS activity measurement is performed ovet 7 days all together three times during the whole intervention.

Time frame
From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

Turku University of Applied Sciences

Collaborator

Tampere University Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: