Clinical trial NCT03664947: The Impact of Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia
Official title: The Impact of Video Based Game Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia: Randomized Single Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology Problem
Sleep
Keywords: exercise
sleep problems
acute lymphoblastic leukemia
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep is one of the basic and indispensable daily life activities that affect the quality of life and health of individuals and is a concept with physiological, psychological and social dimensions. In the literature, sleep difficulties and problems have begun to be investigated in children with acute lymphoblastic leukemia and have not been found in national publications. In these children, sleep quality, strengths and disorders and a study evaluating this variation on a scale have not been found. For this reason, our study will be done in order to determine the factors affecting sleep and sleep in children with cancer and to show the effect of exercise on these factors.

Detailed description: Primeraly that progresses in the disease process, secondary problems seen with the effects of symptoms make it difficult to cope with disease and treatment process in children with acute lymphoblastic leukemia (ALL) . Sleep difficulty is not affected by the direct effects of the disease but it is affected and becomes more difficult with the fatigue and difficulty of treatment as a secondary. Parents with ALL children stated that they experienced 12.4% of sleeping difficulty. It turns out that about a quarter of the children are sleeping problems. It is stated that 27% of these children have drowsiness, and more than 25% of them have frequent awakenings at night. It is also stated that parents use the option of rest-sleep as an option to benefit from treatment in coping with the disease, but children with sleeping difficulties also make it difficult to treat them. Being a healthcare professional as a biopsychosocial approach model and planning the treatment interventions for the deficiencies and disorders that will be done in order to get rid of the symptoms of the disease as soon as possible will make it easier to cope with the disease with both child and parent and multidisciplinary approach. In this way, we will investigate the effects of children's exercise habits on their sleep and sleep related complaints by using video-based game consoles which are currently used in our workout approaches. The games to be selected from the aerobic exercise programs that are used to increase the functional capacity on the basis of exercise will also be targeted to the exercises with maximum motivation and participation of the children. In the exercises where goodness and continuity are also taken into consideration, in-game guidance will be provided with verbal commands under the supervision of a physiotherapist.

Eligibility criteria: Inclusion Criteria:

* Having ALL a diagnosis
* Being between 2-18 years of age
* Therapy (surgery, chemotherapy, radiotherapy) to be finished

Exclusion Criteria:

* Continue active treatment (surgery, chemotherapy, radiotherapy)
* Recurrence of the disease
* Any mental / physical problem that will have a cooperative problem

Primary outcomes:
measure: Polysomnography, Characteristics of Sleep
timeFrame: 12 weeks
Secondary outcomes:
measure: Childhood Sleep Habit Questionnaire (CSHQ)
timeFrame: 12 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 12 weeks
measure: Pitsburg Sleep Quality Index (PSQI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
References: