Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664947
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Oncology Problem Sleep Other: exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: exercise
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.
Other: exercise
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Fatma Betül Çakır, MD +90 530 464 49 94 fbetulcakir@gmail.com
Contact: Müberra Tanrıverdi, PhD +905336046188 tanriverdi88@hotmail.com

Locations
Layout table for location information
Turkey
Bezmialem Vakıf University Recruiting
İstanbul, Turkey, 34090
Contact: Fatma Betül Çakır, MD    +905304644994    fbetulcakir@gmail.com   
Sponsors and Collaborators
Bezmialem Vakif University

Layout table for additonal information
Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03664947     History of Changes
Other Study ID Numbers: BezmialemVUFBC
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bezmialem Vakif University:
exercise
sleep problems
acute lymphoblastic leukemia

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases