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

NCT ID: NCT03664947

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2019-12-31

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.

Conditions

Oncology Problem; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

exercise

Intervention Type: OTHER

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.

control

No exercise training applied for the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BezmialemVUFBC

Identifier Type: -

Identifier Source: org_study_id