Effective Implementation of the Physical Activity and Mot... | NCT07488494

ID	Type	Description	Link
368294	Other Grant/Funding Number	Finnish Academy, ACTIVE programme

Status Module

Name	Class
Turku University of Applied Sciences	OTHER
Tampere University Hospital	OTHER

Oversight Module

Description Module

Detailed Description

The previous exercise guidelines for children with cancer indicate that physical activity is advisable during cancer treatments. However, it has been noted that while the effects of exercise interventions on various health variables in children with cancer have been found effective, there is a recognized need to further investigate the barriers of exercise interventions. The research project will gather new empirical data, thus providing opportunities for understand implementation of evidence-based recommendations in the studied context.

The objectives are: 1) to investigate the association of planned technology-enhanced exercise guidance on child's physical activity, motor performance and quality of life during the cancer treatment and 6 and 12 months after the intensive treatment period 2) to investigate, which factors have effect on exercise intervention's acceptability, fidelity, sustainability and feasibility.

In order to reach these objectives, EMPOWER sets the following research questions for itself:

What factors affect the feasibility and the acceptability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
What factors affect the degree to which an intervention improving physical activity and motor skills during the cancer treatment on 3-6-year-old children, was implemented as prescribed or intended (Fidelity)
What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
What is the association of intervention on daily condition, and quality of life of children aged 3-6 years? This study addresses the following main hypothesis: Physical exercise during cancer treatment enables a child to keep PA level and motor performance age-appropriate at the end of cancer treatment. Another hypothesis is that support and guidance to the nursing staff and care givers on the significance of and methods of implementing the PA intervention, will enhance the intervention's fidelity and acceptability, feasibility and sustainability. Additionally, a hypothesis is that feedback on the child's condition during the treatment period will encourage and help the child and her guardians to implement the PA intervention during treatment. A further hypothesis is that physical exercise will not worsen the child's condition and quality of life during and after cancer treatment but might even promote them.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
EMPOWER intervention	Other	a single arm study	Behavioral: Digital tool for physical activity guidance and follow-up Behavioral: Physical activity guidance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
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.	From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
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.	From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
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.	From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Feasibility of using the mobile EMPOWER application is explored by interviewing the parents/caregivers	Parents/caregivers of the participating children are interviewed three times during the study period using semi-structured method developed by the study team.	From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).

Eligibility Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33538309	Background	Wurz A, McLaughlin E, Lategan C, Ellis K, Culos-Reed SN. Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Transl Behav Med. 2021 Apr 7;11(3):699-708. doi: 10.1093/tbm/ibaa136.

IPD Sharing Statement Module