Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-16
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
Main objective :
Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16
Hypothesis :
Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children from 5 to 16 with haematological cancer undergoing treatment
Subjects and their parents who were informed about the study and gave informed consent.
Enrollment in the Social Security system
Disqualifiers
Children on high-dose corticosteroids
Children under anxiolytic treatment
Children with sleep disorders (sleep apnea)
Children taking melatonin or sleeping pills
Trial design
Design model
Crossover
Treatments tested in this trial
practice adapted physical activity
Behavioralpractice daily adapted physical activity during 4 days
control arm
Other interventionpractice once adapted physical activity during 4 days
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: standardActive comparator 1 intervention
Group B: daily adapted physical activityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of sleep
daily calendar with information about child's sleep complete by parents
Time frame
the morning and the evening, from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 daysSecondary outcomes
1
Number of sleep's hour and night awakenings
wear a sleep recorder during the night
Time frame
Each night from the bedtime to the wake up time, from the bedtime of the first day to the wake up time of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days2
rate of daily human physical activity in met/day
wear a wearable device allday and night long
Time frame
from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days3
children quality of life
parent-completed questionnaire
Time frame
the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days4
chair stand-up test
maximum sit-up and stand-up from a chair during one minute
Time frame
the morning of the first day and the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov