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临床试验/NCT06794762
NCT06794762招募中不适用

Examination of the Effects of Core Stabilization Exercises on Physical Function, Functional Muscle Strength, Functional Exercise Capacity, Postural Control and Fatigue in Children with Acute Lymphoblastic Leukemia Receiving Maintenance Treatment

Karamanoğlu Mehmetbey University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
2
主要终点
Timed Up and Go Test (TUG)

研究概览

简要总结

The goal of this clinical trial is to investigate the effects of core stabilization exercises applied in addition to the conventional exercise program on physical function, functional muscle strength, functional exercise capacity, postural control and fatigue in children with acute lymphoblastic leukemia receiving maintenance treatment.

Participants will be divided into two groups; the first group will be given a conventional exercise program, while the second group will be given core stabilization exercises in addition to the conventional exercise program.

详细描述

Acute Lymphoblastic Leukemia (ALL) is a malignancy resulting from the abnormal proliferation of lymphoid cells that can invade the bone marrow, blood, and extramedullary regions, and it is the most common malignancy in childhood. Specific chemotherapy-related problems are frequently observed in children with ALL. These include a reduction in cardiopulmonary fitness, balance, posture, proximal muscle strength, and flexibility, as well as postural control issues and functional mobility impairments, in addition to fatigue.

The aim of this study is to investigate the effects of core stabilization exercises, applied in addition to a conventional exercise program, on physical function, functional muscle strength, functional exercise capacity, postural control, and fatigue in children with Acute Lymphoblastic Leukemia undergoing maintenance therapy.

Participants will be divided into two groups: the first group will follow a conventional exercise program, while the second group will receive core stabilization exercises in addition to the conventional program. All participants will be randomly assigned to the groups using the software available at http://www.randomizer.org. The exercise sessions will be conducted three times a week for a total of 8 weeks, with 24 sessions in total. Demographic information will be recorded for participants who agree to take part in the study and meet the inclusion criteria. The scales and tests designed to assess the participants' physical function, functional muscle strength, functional exercise capacity, postural control, and fatigue will be administered both before and after the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Children aged 7-18
  • Diagnosed with ALL
  • In the maintenance phase of chemotherapy
  • Children without acute thrombosis, active ischemia, hemodynamic instability
  • Children without uncontrolled pain
  • Children who can follow verbal instructions.

排除标准

  • Children who have received or are receiving cranial radiotherapy
  • Children with any cardiovascular disease, acute or chronic respiratory disease
  • Children with acute or chronic bone, joint, muscle problems
  • Children diagnosed with neuromotor deficits or genetic disorders
  • Children with vision problems other than refractive errors

结局指标

主要结局

Timed Up and Go Test (TUG)

时间窗: After 8 weeks of treatment

This test aims to evaluate the physical function.

Sit-up Test

时间窗: After 8 weeks of treatment

This aims to evaluate the functional muscle strength.

6-Minute Walk Test

时间窗: After 8 weeks of treatment

This test aims to evaluate the functional exercise capacity.

Balance Error Scoring System

时间窗: After 8 weeks of treatment

This test aims to evaluate the postural control.

Pediatric Quality of Life Multidimensional Fatigue Scale

时间窗: After 8 weeks of treatment

This scale aims to evaluate the fatigue in pediatric patients.

次要结局

未报告次要终点

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melike Müsevitoğlu

Melike Müsevitoğlu

Karamanoğlu Mehmetbey University

研究点 (2)

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