Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia

Not Applicable

Recruiting

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT06794762
• Lead Sponsor: Karamanoğlu Mehmetbey University

Brief Summary

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study Start: 2025-01-14
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey