Protocol summary

Study aim
The overall goal of the present study is to compare the effect of 10 weeks of balance and aerobic exercises on the balance, cancer-related fatigue, and quality of life in children with leukemia.
Design
The study groups include the aerobic intervention group, the balance intervention group, and the control group. It has a control group, with factorial groups, non-blinded, randomized; the tests are conducted on-site/in the field on 27 patients.
Settings and conduct
The research is conducted at Bu-Ali Hospital in Sari, and the pre-tests include assessment of balance, fatigue (CFS-24h), and quality of life (PedsQL).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Children with leukemia between the ages of 5 and 15 years. 2. Children in the maintenance phase of treatment with more than 20 weeks elapsed since the start of the phase. 3. Height, weight, and BMI within the normal range. 4. Children must be capable of performing physical activity. 5. Must not have symptoms related to acute illness, for example, fever (< 38 degrees Celsius), severe anemia. Exclusion Criteria: Non-leukemic individuals are excluded from entry."
Intervention groups
Sample: 27 children with leukemia undergoing chemotherapy were randomly divided into three groups (9 children in each group). Balance Exercise Group: Static and dynamic exercises including two-leg standing, tandem stance, single-leg stance, and crossover walking; for 10 weeks, 2 sessions per week, with each session including a warm-up and cool-down. Aerobic Exercise Group: Outdoor walking for 10 weeks, 2 sessions per week; exercise intensity will be controlled based on the Karvonen formula (50% to 75% HRR) and the Visual Analog Scale (RPE=11-13). Control Group: No exercise intervention, maintaining usual lifestyle and receiving current medical care.
Main outcome variables
Aerobic fitness and balance improvement.

General information

Reason for update
Acronym
BATCL
IRCT registration information
IRCT registration number: IRCT20251023067733N1
Registration date: 2025-11-18, 1404/08/27
Registration timing: prospective

Last update: 2025-11-18, 1404/08/27
Update count: 0
Registration date
2025-11-18, 1404/08/27
Registrant information
Name
Negar Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 0789
Email address
negarazizi183@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
"Comparison of the effects of balance and aerobic exercises on children with leukemia"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Non-leukemic individuals should not enter the study
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics code of Shahid Beheshti University
Street address
Farhang Street, Farhangian Alley, Third Alley, Sayeh Apartment.
City
Sari
Province
Mazandaran
Postal code
4818815393
Approval date
2025-09-20, 1404/06/29
Ethics committee reference number
IR.SBU.REC.1404.172

Health conditions studied

1

Description of health condition studied
Leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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.

Intervention groups

1

Description
Control group: regular daily activities.
Category
Rehabilitation

2

Description
Intervention group: balance exercises.
Category
Rehabilitation

3

Description
Intervention group: aerobic exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahak hospital
Full name of responsible person
Amir hossein barati
Street address
pasdaran blvrd
City
sari
Province
Mazandaran
Postal code
4815838465
Phone
+98 11 3334 1999
Fax
+98 11 3334 1999
Email
mahakcharity@gmail.com
Web page address
https://maahakcharity.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Shahid beheshti
Full name of responsible person
Amir hossein Barati
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
+98 21 2243 1607
Email
ahbarati20@gmail.com
Web page address
https://www.sbu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahid beheshti
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Shahid beheshti
Full name of responsible person
Amir hossein Barati
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
+98 21 2243 1607
Email
ah_barati@gmail.com
Web page address
https://sport.sbu.ac.ir/~ah_barati

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shahid beheshti
Full name of responsible person
Amir hossein Barati
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
+98 21 2243 1607
Email
ah_barati@gmail.com
Web page address
https://sport.sbu.ac.ir/~ah_barati

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid beheshti
Full name of responsible person
Negar azizi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
+98 21 2243 1607
Email
negarazizi183@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
I will make a decision after completing the research and consulting with my supervisor.
When the data will become available and for how long
After completing the research and after the article is published.
To whom data/document is available
I will make a decision after completing the research and consulting with my supervisor.
Under which criteria data/document could be used
I will make a decision after completing the research and consulting with my supervisor.
From where data/document is obtainable
To all authors
What processes are involved for a request to access data/document
Request to the authors
Comments
I will make a decision after completing the research and consulting with my supervisor.
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