The Impact of Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT03664947|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oncology Problem Sleep||Other: exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Video Based Game Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia: Randomized Single Blind Controlled Study|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
The exergaming training programs have included recent daily living activities in games. In our study we have planned the Nintendo Wii Fit Plus Game Console in the therapy training.
After the initial evaluations, a video-based gaming console exercise program will be implemented for 8 weeks, taking into account the possibility of accepting and participating in treatment with children. Exercises applied by a Nintendo Wii Fit Plus System. Evaluations will be repeated at the end of treatment.
No Intervention: control
No exercise training applied for the control group.
- Polysomnography, Characteristics of Sleep [ Time Frame: 12 weeks ]Polysomnography is used increasingly to investigate patients with possible sleep apnoea/ hypopnoea syndrome. It is a report that which indicate sleep quality.
- Childhood Sleep Habit Questionnaire (CSHQ) [ Time Frame: 12 weeks ]The CSHQ is a parent-rated questionnaire comprised of 45 items; 33 scored questions, and 7 additional items intended to provide other relevant information pertaining to sleep behavior. Each scored question is rated on a 3-point scale as occurring "usually", "sometimes", or "rarely". A number of items on the questionnaire are reverse-scored, so that higher scores consistently indicate problem behaviors. Ratings are combined to form eight subscales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep Disordered Breathing, and Daytime Sleepiness. A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A Total Sleep Disturbances score of over 41 indicates a pediatric sleep disorder, as this cutoff has been shown to accurately identify 80% of children with a clinically diagnosed sleep disorder.
- Epworth Sleepiness Scale (ESS) [ Time Frame: 12 weeks ]The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer.
- Pitsburg Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ]The Pitsburg Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664947
|Contact: Fatma Betül Çakır, MD||+90 530 464 49 firstname.lastname@example.org|
|Contact: Müberra Tanrıverdi, PhDemail@example.com|
|Bezmialem Vakıf University||Recruiting|
|İstanbul, Turkey, 34090|
|Contact: Fatma Betül Çakır, MD +905304644994 firstname.lastname@example.org|