Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

NCT ID: NCT06794762

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-14

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Exercises will be applied to the participants participating in the study 3 days a week, 8 weeks, and 24 sessions in total.

Group Type EXPERIMENTAL

Conventional exercises

Intervention Type 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.

Intervention group

Exercises will be applied to the individuals participating in the study 3 days a week, 8 weeks, and 24 sessions in total. Exercises will be applied after the conventional therapy sessions.

Group Type EXPERIMENTAL

Core stabilization exercises in addition to conventional exercises

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role collaborator

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Melike Müsevitoğlu

Melike Müsevitoğlu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Melike Müsevitoğlu, MSc.

Role: CONTACT

+90 (543) 3518466

Facility Contacts

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Melike Müsevitoğlu

Role: primary

+905433518466

Other Identifiers

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2024/023-12

Identifier Type: -

Identifier Source: org_study_id

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