Clinical trial NCT06794762: Effects of Core Stabilization Exercises in Children with Acute Lymphoblastic Leukemia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Maintenance Chemotherapy
Rehabilitation
Exercise
Core Stabilization Exercises
Cancer
Physical Function
Functional Muscle Strength
Functional Exercise Capacity
Postural Control
Fatigue
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2025-01-27
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: Before 8 weeks of treatment
measure: Timed Up and Go Test (TUG)
timeFrame: After 8 weeks of treatment
measure: Sit-up Test
timeFrame: Before 8 weeks of treatment
measure: Sit-up Test
timeFrame: After 8 weeks of treatment
measure: 6-Minute Walk Test
timeFrame: Before 8 weeks of treatment
measure: 6-Minute Walk Test
timeFrame: After 8 weeks of treatment
measure: Balance Error Scoring System
timeFrame: Before 8 weeks of treatment
measure: Balance Error Scoring System
timeFrame: After 8 weeks of treatment
measure: Pediatric Quality of Life Multidimensional Fatigue Scale
timeFrame: Before 8 weeks of treatment
measure: Pediatric Quality of Life Multidimensional Fatigue Scale
timeFrame: After 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References: