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Recruiting NCT06794762

Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

No phase Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional exercises, Core stabilization exercises in addition to conventional exercises.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Conventional exercises
    Aerobic exercise and stretching exercises will be applied in the conventional exercise program. A 20-30 minute walking will be done as aerobic exercise. Stretching exercises will be done for major muscle groups in 3 sets and 10 repetitions.
  • Other Core stabilization exercises in addition to conventional exercises
    In addition to the conventional exercise program, core stabilization exercises will be applied. During the exercises, participants will be trained on neutralizing the spine and working the transverse abdominis and multifidus muscles, correct postural control, and performing the exercises with diaphragmatic breathing.

Primary outcome measures

  • Timed Up and Go Test (TUG) [Time frame: Before 8 weeks of treatment]
  • Timed Up and Go Test (TUG) [Time frame: After 8 weeks of treatment]
  • Sit-up Test [Time frame: Before 8 weeks of treatment]
  • Sit-up Test [Time frame: After 8 weeks of treatment]
  • 6-Minute Walk Test [Time frame: Before 8 weeks of treatment]
  • 6-Minute Walk Test [Time frame: After 8 weeks of treatment]
  • Balance Error Scoring System [Time frame: Before 8 weeks of treatment]
  • Balance Error Scoring System [Time frame: After 8 weeks of treatment]
  • Pediatric Quality of Life Multidimensional Fatigue Scale [Time frame: Before 8 weeks of treatment]
  • Pediatric Quality of Life Multidimensional Fatigue Scale [Time frame: After 8 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Necmettin Erbakan University — Konya

Identifiers

NCT: NCT06794762 · 2024/023-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗