Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

January 29, 2025 updated by: Melike Müsevitoğlu, Karamanoğlu Mehmetbey University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Recruiting
        • Necmettin Erbakan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
Exercises will be applied to the participants participating in the study 3 days a week, 8 weeks, and 24 sessions in total.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUG)
Time Frame: Before 8 weeks of treatment
This test aims to evaluate the physical function.
Before 8 weeks of treatment
Timed Up and Go Test (TUG)
Time Frame: After 8 weeks of treatment
This test aims to evaluate the physical function.
After 8 weeks of treatment
Sit-up Test
Time Frame: Before 8 weeks of treatment
This test aims to evaluate the functional muscle strength
Before 8 weeks of treatment
Sit-up Test
Time Frame: After 8 weeks of treatment
This aims to evaluate the functional muscle strength.
After 8 weeks of treatment
6-Minute Walk Test
Time Frame: Before 8 weeks of treatment
This test aims to evaluate the functional exercise capacity.
Before 8 weeks of treatment
6-Minute Walk Test
Time Frame: After 8 weeks of treatment
This test aims to evaluate the functional exercise capacity.
After 8 weeks of treatment
Balance Error Scoring System
Time Frame: Before 8 weeks of treatment
This test aims to evaluate the postural control.
Before 8 weeks of treatment
Balance Error Scoring System
Time Frame: After 8 weeks of treatment
This test aims to evaluate the postural control.
After 8 weeks of treatment
Pediatric Quality of Life Multidimensional Fatigue Scale
Time Frame: Before 8 weeks of treatment
This scale aims to evaluate the fatigue in pediatric patients.
Before 8 weeks of treatment
Pediatric Quality of Life Multidimensional Fatigue Scale
Time Frame: After 8 weeks of treatment
This scale aims to evaluate the fatigue in pediatric patients.
After 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karamanoğlu Mehmetbey University

Collaborators

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/023-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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