NCT06794762

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 13, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

Acute Lymphoblastic LeukemiaMaintenance ChemotherapyRehabilitationExerciseCore Stabilization ExercisesCancerPhysical FunctionFunctional Muscle StrengthFunctional Exercise CapacityPostural ControlFatigue

Outcome Measures

Primary Outcomes (10)

  • Timed Up and Go Test (TUG)

    This test aims to evaluate the physical function.

    Before 8 weeks of treatment

  • Timed Up and Go Test (TUG)

    This test aims to evaluate the physical function.

    After 8 weeks of treatment

  • Sit-up Test

    This test aims to evaluate the functional muscle strength

    Before 8 weeks of treatment

  • Sit-up Test

    This aims to evaluate the functional muscle strength.

    After 8 weeks of treatment

  • 6-Minute Walk Test

    This test aims to evaluate the functional exercise capacity.

    Before 8 weeks of treatment

  • 6-Minute Walk Test

    This test aims to evaluate the functional exercise capacity.

    After 8 weeks of treatment

  • Balance Error Scoring System

    This test aims to evaluate the postural control.

    Before 8 weeks of treatment

  • Balance Error Scoring System

    This test aims to evaluate the postural control.

    After 8 weeks of treatment

  • Pediatric Quality of Life Multidimensional Fatigue Scale

    This scale aims to evaluate the fatigue in pediatric patients.

    Before 8 weeks of treatment

  • Pediatric Quality of Life Multidimensional Fatigue Scale

    This scale aims to evaluate the fatigue in pediatric patients.

    After 8 weeks of treatment

Study Arms (2)

Control group

EXPERIMENTAL

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

Intervention group

EXPERIMENTAL

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

Interventions

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.

Control group

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 group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaMotor ActivityNeoplasmsFatigue

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Melike Müsevitoğlu, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Melike Müsevitoğlu

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 27, 2025

Study Start

January 14, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations