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IRCT20251023067733N1 IRCT 2025-11-18 The University of Shahid beheshti "Comparison of the effects of balance and aerobic exercises on children with leukemia" BATCL A comparison of the effects of 10 weeks of balance and aerobic exercises on the balance, cancer-related fatigue, and quality of life of children with leukemia. 2025-11-22 anticipated 27 Complete https://irct.ir/trial/87163 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple. Unit of randomization: Individual. Stratified randomization. Randomization tool based on statistical software. Method of generating the random sequence: The allocation sequence was first defined in the aforementioned software by determining block sizes, allocation ratio, and stratification variables. Then, the final list was generated by coding the groups as 'A' and 'B' and kept in an encrypted file. None of the research team members had access to this file until participants were allocated to the groups. Allocation concealment was achieved by using opaque, sealed, and tamper-evident envelopes; each envelope had a serial number synchronized with the random sequence. Upon confirming the eligibility criteria, the person responsible for enrolling study participants opened the envelope corresponding to the individual's number and assigned the participant to the intervention or control group based on the contents inside the envelope. This process prevented the prediction of allocation and eliminated selection bias. N/A Leukemia. Intervention 1: Control group: regular daily activities. Intervention 2: Intervention group: balance exercises. Intervention 3: Intervention group: aerobic exercises. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will make a decision after completing the research and consulting with my supervisor.
public Amir hossein Barati
Evin
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 0000 ah_barati@gmail.com The University of Shahid beheshti scientific Amir hossein Barati
Evin
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 0000 ah_barati@gmail.com The University of Shahid beheshti Iran (Islamic Republic of) Children with leukemia in the age range of 5 to 15 years Children in the maintenance phase of treatment and time elapsed since the start of the phase of more than 20 weeks Height, weight, and BMI within the normal range Children should be capable of performing physical activity Should not have acute illness-related symptoms, for example, fever (< 38 degrees Celsius), severe anemia 5 years 15 years Both Non-leukemic individuals should not enter the study C91 Lymphoid leukemia Rehabilitation Rehabilitation Rehabilitation Control group: regular daily activities. Intervention group: balance exercises. Intervention group: aerobic exercises. Balance score in the Modified Stork Test and Tandem Walking Test. Timepoint: The primary outcomes are measured at two time points: before the start of the intervention and immediately after the completion of 10 weeks of balance and aerobic exercises. Method of measurement: Balance assessment of children: using the modified Stork Test and Tandem Walking. Cancer-related fatigue assessment. Timepoint: Pre-test and post-test. Method of measurement: Cancer-related fatigue assessment: using the Persian version of the Children, Parents, and Staff Fatigue Questionnaire CFS-24h. Assessment of children’s quality of life. Timepoint: Pre-test and in post-test. Method of measurement: Assessing Quality of Life in Children: Using the Child Quality of Life Inventory Questionnaire. Controlling Exercise Intensity. Timepoint: Pre-test and Post-test. Method of measurement: Controlling exercise intensity: using the Visual Analog Scale of Perceived Exertion and measuring heart rate. The University of Shahid beheshti Approved 2025-09-20 Ethics code of Shahid Beheshti University Farhang Street, Farhangian Alley, Third Alley, Sayeh Apartment. Sari Mazandaran Iran (Islamic Republic of)