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

NCT03664947 | Completed DMC

• 1 other identifier: BezmialemVUFBC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology Problem; Sleep

Keywords

exercise; sleep problems; acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Polysomnography, Characteristics of Sleep

  Polysomnography is used increasingly to investigate patients with possible sleep apnoea/ hypopnoea syndrome. It is a report that which indicate sleep quality.

  12 weeks

Secondary Outcomes (3)

• Childhood Sleep Habit Questionnaire (CSHQ)

  12 weeks

• Epworth Sleepiness Scale (ESS)

  12 weeks

• Pitsburg Sleep Quality Index (PSQI)

  12 weeks

Study Arms (2)

exercise

EXPERIMENTAL

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

control

NO INTERVENTION

No exercise training applied for the control group.

Interventions

exercise 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.

exercise

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Parasomnias; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: September 11, 2018
• Study Start: October 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)