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NCT Number: NCT06794762

Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Behavior Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

Location status: Recruiting

Location contact

Melike Müsevitoğlu

CONTACT

[email protected]

+905433518466

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional exercises

Other

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.

Core stabilization exercises in addition to conventional exercises

Other

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 outcomes

  1. Timed Up and Go Test (TUG)

    Time frame: Before 8 weeks of treatment

    This test aims to evaluate the physical function.

  2. Timed Up and Go Test (TUG)

    Time frame: After 8 weeks of treatment

    This test aims to evaluate the physical function.

  3. Sit-up Test

    Time frame: Before 8 weeks of treatment

    This test aims to evaluate the functional muscle strength

  4. Sit-up Test

    Time frame: After 8 weeks of treatment

    This aims to evaluate the functional muscle strength.

  5. 6-Minute Walk Test

    Time frame: Before 8 weeks of treatment

    This test aims to evaluate the functional exercise capacity.

  6. 6-Minute Walk Test

    Time frame: After 8 weeks of treatment

    This test aims to evaluate the functional exercise capacity.

  7. Balance Error Scoring System

    Time frame: Before 8 weeks of treatment

    This test aims to evaluate the postural control.

  8. Balance Error Scoring System

    Time frame: After 8 weeks of treatment

    This test aims to evaluate the postural control.

  9. Pediatric Quality of Life Multidimensional Fatigue Scale

    Time frame: Before 8 weeks of treatment

    This scale aims to evaluate the fatigue in pediatric patients.

  10. Pediatric Quality of Life Multidimensional Fatigue Scale

    Time frame: After 8 weeks of treatment

    This scale aims to evaluate the fatigue in pediatric patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Melike Müsevitoğlu, MSc.

CONTACT

[email protected]

+90 (543) 3518466

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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