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临床试验/NCT05294380
NCT05294380Unknown不适用

Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients

Trakya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Physical performance

研究概览

简要总结

In children, both malnutrition and sarcopenia are associated with prolongation of hospital stay, increased morbidity, mortality, and health-related complications. While the decrease in muscle strength refers to "probable sarcopenia", "sarcopenia" is confirmed by adding the decrease in muscle quantity/quality to this situation. In case all three criteria are together, "severe sarcopenia" is mentioned. The aim of this study is the evaluate whether there is a difference in the risk of sarcopenia and related factors in pediatric oncological children compared to healthy controls matched for body mass index group, physical activity level group, sex, and age.

Our research was planned as cross-sectional and descriptive research. Patients diagnosed with pediatric oncologic cancer will be included. Demographic data, malnutrition, the risk for sarcopenia, physical activity status, smartphone addiction, fatigue, and hospital anxiety and depression will be evaluated with questionnaires.

Muscle strength (manual muscle strength assessment), Muscle quantity (the bilateral calf circumference with a tape measure and by bioelectrical impedance analysis (BIA)), and physical performance (Short Physical Performance Battery) will be evaluated by the physiotherapist.

The data of the research will be evaluated with the SPSS package program. After examining the conformity of the data that can be measured in statistical evaluations to a normal distribution with a single sample Kolmogorov Smirnov test, one-way analysis of variance will be applied for comparisons between groups for those with normal distribution, and t-test for independent groups. Kruskal Wallis analysis of variance and Mann Whitney U test will be used in the evaluation of data that do not conform to the normal distribution. Pearson χ2 and Yates corrected Pearson χ2 test Fisher's exact χ2 will be used for qualitative data. As descriptive statistics, numbers and percentages will be given for categorical data, and Median (Min-Max) values and arithmetic mean±standard deviation will be given for quantitative data. For all statistics, the limit of significance will be chosen as bidirectional p<0.05.

详细描述

As incidence and survival, rates increase in childhood and adolescent cancers, the importance of rehabilitation in this area increases (1-5). Functional limitations in the physical and cognitive domains are reported by children throughout the continuum of cancer care. These limitations are also experienced in very young children under 4 years of age with leukemia and lymphoma, adolescents and young adults struggling with leukemia, sarcoma, or central nervous system tumors (3, 6). Studies in adults who have won the childhood malignancy struggle report adulthood problems. Among these problems, deterioration of physical function, decrease in physical fitness, deterioration of neurocognition, fatigue, and pain, which affect their employment, participation in the life, and quality of life, are reported (2, 5, 7, 8). The roles of rehabilitation professionals, physical medicine and rehabilitation specialists, and physiotherapists in the childhood cancer population are particularly emphasized in the literature to prevent these limitations (1).

Malnutrition in children with chronic diseases is a common condition that causes problems in patient care. Sarcopenia or decreased musculoskeletal muscle mass contributes to the alteration of muscle function. This has been demonstrated in adults with chronic disease, but its impact on clinical outcomes in children has not been adequately described in the pediatric literature. Research in this area is affected by the lack of a uniform definition of sarcopenia in children. However, there is concern that childhood sarcopenia may have a long-term negative impact on growth, neurocognitive development, and quality of life-extending into adulthood. The similarities between sarcopenia and malnutrition are depleted lean muscle mass, changes in muscle function, and suboptimal food intake leading to nutritional deficiencies. In pediatric patients, this leads to growth failure and a potential neurodevelopmental delay in cognition, gross and fine motor development.

In children, both malnutrition and sarcopenia are associated with prolongation of hospital stay, increased morbidity, mortality, and health-related complications (3).

In adult oncological patients (over 18 years of age), the risk of sarcopenia, which is stated to predict malnutrition, is reported to be 40% (9).

As the investigators mentioned before, there is no single definition of sarcopenia with strict rules in childhood sarcopenia. However, in the 2019 European update, three criteria are emphasized in the diagnosis of sarcopenia for elderly individuals. These criteria are:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be between the ages of 2-18 years
  • Being under pediatric oncology outpatient/clinical follow-up
  • Being able to stand unaided without using a cane/walker

排除标准

  • Having any of the diagnoses of hypertension, any cardiac arrhythmia-conduction disorders, coronary artery disease, heart failure, diabetes mellitus, hyperlipidemia, cardiovascular diseases, COPD, pulmonary infection, active infection.
  • Depression Illness that causes balance problems
  • Peripheral vascular disease
  • Presence of disease that prevents standing up with support.
  • Presence of diseases that may cause muscle mass loss (cerebral palsy, neuromuscular disease, congenital metabolic disorder, brain damage) mental retardation
  • Children with a severe emotional disorder, adjustment disorder
  • Physical disability to prevent safe and appropriate testing
  • Having used anti-flu medicine in the last 1 week
  • Failure to obtain consent.

结局指标

主要结局

Physical performance

时间窗: Seven months

Physical performance will be determined by Short Physical Performance Battery (SPPB). The SPPB is a composite test that includes assessment of gait speed, a balance test, and a chair stand test.

Muscle strength.

时间窗: Seven months

Upper extremities (manual muscle strength assessment), the lower extremities will be evaluated (by manual muscle strength assessment and chair rise test). The chair stand test (also called chair rise test) can be used as a proxy for strength of leg muscles (quadriceps muscle group). The chair stand test measures the amount of time needed for a patient to rise five times from a seated position without using his or her arms; the timed chair stand test is a variation that counts how many times a patient can rise and sit in the chair over a 30-second interval. Since the chair stand test requires both strength and endurance, this test is a qualified but convenient measure of strength.

Muscle quantity.

时间窗: Seven months

Bioelectrical impedance analysis (BIA) has been explored for estimation of total or Appendicular Skeletal Muscle Mass (ASM). BIA equipment does not measure muscle mass directly, but instead derives an estimate of muscle mass based on whole-body electrical conductivity. BIA uses a conversion equation that is calibrated with a reference of DXA-measured lean mass in a specific population. BIA equipment is affordable, widely available, and portable, especially single-frequency instruments. Muscle quantity will be determined by measuring the bilateral calf circumference with a tape measure and by BIA, which is considered one of the main standard tools for sarcopenia case-finding in clinical practice. Whole-body skeletal muscle mass (SMM) or Appendicular skeletal muscle mass (ASMM) predicted by BIA.

次要结局

  • Physical activity for preschool children and school-age children and adolescents(Seven months)
  • Symptoms or signs of sarcopenia(Seven months)
  • Physical activity for parent(Seven months)
  • Smartphone Addiction(Seven months)
  • Childhood cancer fatigue(Seven months)
  • Physical activity for elementary 4-8th grades(Seven months)
  • The presence of malnutrition(Seven months)
  • Depression status(Seven months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

FİLİZ TUNA

Assoc Prof

Trakya University

研究点 (1)

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